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Aurovela Fe 1.5/30 Disease Interactions

There are 24 disease interactions with Aurovela Fe 1.5 / 30 (ethinyl estradiol / norethindrone).

Major

Combined oral contraceptives (applies to Aurovela Fe 1.5/30) smoking

Major Potential Hazard, Moderate plausibility.

Cigarette smoking increases the risk of serious cardiovascular events from estrogen-containing combination oral contraceptives (COC). This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in females who are over 35 years of age and smoke.

References

  1. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  2. "Product Information. Gianvi (drospirenone-ethinyl estradiol)." Teva Pharmaceuticals USA (2017):
  3. "Product Information. Alesse-28 (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Canada Inc (2017):
  4. "Product Information. Lo Loestrin Fe (ethinyl estradiol-norethindrone)." Warner Chilcott Laboratories (2017):
  5. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 5 references
Major

Contraceptives (applies to Aurovela Fe 1.5/30) abnormal genital bleeding

Major Potential Hazard, Moderate plausibility. Applicable conditions: Abnormal Uterine Bleeding

The use of contraceptives is contraindicated when there is an undiagnosed abnormal genital bleeding. Adequate diagnostic measures should be undertaken to rule out the presence of any malignancy.

References

  1. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  2. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals (2006):
  3. "Product Information. Liletta (levonorgestrel)." Actavis Pharma, Inc. (2016):
Major

Estrogens (applies to Aurovela Fe 1.5/30) abnormal vaginal bleeding

Major Potential Hazard, High plausibility. Applicable conditions: Abnormal Uterine Bleeding

The use of estrogens is contraindicated in patients with undiagnosed, abnormal vaginal bleeding. Prolonged (> 1 year), unopposed estrogen use (i.e. estrogen without concomitant progestin therapy) has been associated with a significant, dose-related risk of endometrial carcinoma. The risk may be offset substantially by the addition of a progestin but may not be completely abolished. Prior to initiating estrogen therapy, appropriate diagnostic tests should be performed in patients with abnormal vaginal bleeding to rule out endometrial malignancy. The same applies if recurrent or persistent bleeding develops during estrogen therapy.

References

  1. Obrink A, Bunne G, Collen J, Tjernberg B "Endometrial cancer and exogenous estrogens." Acta Obstet Gynecol Scand 58 (1979): 123
  2. Spengler RF, Clarke EA, Woolever CA, Newman AM, Osborn RW "Exogenous estrogens and endometrial cancer: a case-control study and assessment of potential biases." Am J Epidemiol 114 (1981): 497-506
  3. Buring JE, Bain CJ, Ehrmann RL "Conjugated estrogen use and risk of endometrial cancer." Am J Epidemiol 124 (1986): 434-41
  4. Persson I, Adami HO, Bergkvist L, Lindgren A, Pettersson B, Hoover R, Schairer C "Risk of endometrial cancer after treatment with oestrogens alone or in conjunction with progestogens: results of a prospective study." BMJ 298 (1989): 147-51
  5. Antunes CM, Strolley PD, Rosenshein NB, Davies JL, Tonascia JA, Brown C, Burnett L, Rutledge A, Pokempner M, Garcia R "Endometrial cancer and estrogen use. Report of a large case-control study." N Engl J Med 300 (1979): 9-13
  6. Gordon J, Reagan JW, Finkle WD, Ziel HK "Estrogen and endometrial carcinoma. An independent pathology review supporting original risk estimate." N Engl J Med 297 (1977): 570-1
  7. Shapiro S, Kelly JP, Rosenberg L, Kaufman DW, Helmrich SP, Rosenshein NB, Lewis JL Jr, Knapp RC, Stolley PD, Schottenfeld D "Risk of localized and widespread endometrial cancer in relation to recent and discontinued use of conjugated estrogens." N Engl J Med 313 (1985): 969-72
  8. Gray LA Sr, Christopherson WM, Hoover RN "Estrogens and endometrial carcinoma." Obstet Gynecol 49 (1977): 385-9
  9. Woodruff JD, Pickar JH "Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone." Am J Obstet Gynecol 170 (1994): 1213-23
  10. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  11. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  12. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  13. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  14. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  15. The Writing Group for the PEPI Trial "Effects of hormone replacement therapy on endometrial histology in postmenopausal women." JAMA 275 (1996): 370-5
  16. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  17. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  18. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  19. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  20. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  21. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  22. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  23. "Product Information. Emcyt (estramustine)." Pharmacia and Upjohn PROD (2001):
  24. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  25. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  26. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  27. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  28. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  29. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
  30. "Product Information. Intrarosa (prasterone)." Theramex Australia Pty Ltd 1 (2023):
View all 30 references
Major

Estrogens (applies to Aurovela Fe 1.5/30) carcinomas (estrogenic)

Major Potential Hazard, High plausibility. Applicable conditions: Neoplasia -- Estrogen Dependent

The use of estrogens is generally contraindicated in patients with known or suspected estrogen-dependent neoplasia such as breast and endometrial cancer, since it may stimulate tumor proliferation. High dosages of estrogens may be used for the palliative treatment of inoperable, metastatic breast cancer, but only in appropriately selected men and postmenopausal women.

References

  1. Ewertz M "Oral contraceptives and breast cancer risk in Denmark." Eur J Cancer 28A (1992): 1176-81
  2. Obrink A, Bunne G, Collen J, Tjernberg B "Endometrial cancer and exogenous estrogens." Acta Obstet Gynecol Scand 58 (1979): 123
  3. Palmer JR, Rosenberg L, Clarke EA, Miller DR, Shapiro S "Breast cancer risk after estrogen replacement therapy: results from the Toronto Breast Cancer Study." Am J Epidemiol 134 (1991): 1386-95
  4. Kaufman DW, Palmer JR, de Mouzon J, Rosenberg L, Stolley PD, Warshauer ME, Zauber AG, Shapiro S "Estrogen replacement therapy and the risk of breast cancer: results from the case-control surveillance study." Am J Epidemiol 134 (1991): 1375-85
  5. Spengler RF, Clarke EA, Woolever CA, Newman AM, Osborn RW "Exogenous estrogens and endometrial cancer: a case-control study and assessment of potential biases." Am J Epidemiol 114 (1981): 497-506
  6. Buring JE, Bain CJ, Ehrmann RL "Conjugated estrogen use and risk of endometrial cancer." Am J Epidemiol 124 (1986): 434-41
  7. Persson I, Adami HO, Bergkvist L, Lindgren A, Pettersson B, Hoover R, Schairer C "Risk of endometrial cancer after treatment with oestrogens alone or in conjunction with progestogens: results of a prospective study." BMJ 298 (1989): 147-51
  8. Hoover R, Glass A, Finkle WD, Azevedo D, Milne K "Conjugated estrogens and breast cancer risk in women." J Natl Cancer Inst 67 (1981): 815-20
  9. Thomas DB, Persing JP, Hutchinson WB "Exogenous estrogens and other risk factors for breast cancer in women with benign breast diseases." J Natl Cancer Inst 69 (1982): 1017-25
  10. Antunes CM, Strolley PD, Rosenshein NB, Davies JL, Tonascia JA, Brown C, Burnett L, Rutledge A, Pokempner M, Garcia R "Endometrial cancer and estrogen use. Report of a large case-control study." N Engl J Med 300 (1979): 9-13
  11. Gordon J, Reagan JW, Finkle WD, Ziel HK "Estrogen and endometrial carcinoma. An independent pathology review supporting original risk estimate." N Engl J Med 297 (1977): 570-1
  12. Bergkvist L, Adami HO, Persson I, Hoover R, Schairer C "The risk of breast cancer after estrogen and estrogen-progestin replacement." N Engl J Med 321 (1989): 293-7
  13. Shapiro S, Kelly JP, Rosenberg L, Kaufman DW, Helmrich SP, Rosenshein NB, Lewis JL Jr, Knapp RC, Stolley PD, Schottenfeld D "Risk of localized and widespread endometrial cancer in relation to recent and discontinued use of conjugated estrogens." N Engl J Med 313 (1985): 969-72
  14. Gray LA Sr, Christopherson WM, Hoover RN "Estrogens and endometrial carcinoma." Obstet Gynecol 49 (1977): 385-9
  15. Delgado-Rodriguez M, Sillero-Arenas M, Martin-Moreno JM, Galvez-Vargas R "Oral contraceptives and cancer of the cervix uteri. A meta-analysis." Acta Obstet Gynecol Scand 71 (1992): 368-76
  16. Sillero-Arenas M, Rodriguez-Contreras R, Delgado-Rodriguez M, Bueno-Cavanillas A, Galvez-Vargas R "Patterns of research. Oral contraceptives and cervical cancer." Acta Obstet Gynecol Scand 70 (1991): 143-8
  17. Lund E "Oral contraceptives and breast cancer. A review with some comments on mathematical models." Acta Oncol 31 (1992): 183-6
  18. Miller DR, Rosenberg L, Kaufman DW, Stolley P, Warshauer ME, Shapiro S "Breast cancer before age 45 and oral contraceptive use: new findings." Am J Epidemiol 129 (1989): 269-80
  19. Rosenberg L, Palmer JR, Clarke EA, Shapiro S "A case-control study of the risk of breast cancer in relation to oral contraceptive use." Am J Epidemiol 136 (1992): 1437-44
  20. Schlesselman JJ "Oral contraceptives and breast cancer." Am J Obstet Gynecol 163 (1990): 1379-87
  21. Turnquest MA "Oral contraceptive use and incidence of cervical intraepithelial neoplasia." Am J Obstet Gynecol 168 (1993): 1895-6
  22. Kaunitz AM "Oral contraceptives and gynecologic cancer: an update for the 1990s." Am J Obstet Gynecol 167 (1992): 1171-6
  23. Romieu I, Willett WC, Colditz GA, Stampfer MJ, Rosner B, Hennekens CH, Speizer FE "Prospective study of oral contraceptive use and risk of breast cancer in women." J Natl Cancer Inst 81 (1989): 1313-21
  24. Olsson H, Moller TR, Ranstam J "Early oral contraceptive use and breast cancer among premenopausal women: final report from a study in southern Sweden." J Natl Cancer Inst 81 (1989): 1000-4
  25. Jones MW, Silverberg SG "Cervical adenocarcinoma in young women: possible relationship to microglandular hyperplasia and use of oral contraceptives." Obstet Gynecol 73 (1989): 984-9
  26. Murray PP, Stadel BV, Schlesselman JJ "Oral contraceptive use in women with a family history of breast cancer." Obstet Gynecol 73 (1989): 977-83
  27. Thomas DB "Oral contraceptives and breast cancer: review of the epidemiologic literature." Contraception 43 (1991): 597-642
  28. Brinton LA "Oral contraceptives and cervical neoplasia." Contraception 43 (1991): 581-95
  29. "Oral contraceptives and neoplasia. WHO Scientific Group." World Health Organ Tech Rep Ser 817 (1992): 1-46
  30. Woodruff JD, Pickar JH "Incidence of endometrial hyperplasia in postmenopausal women taking conjugated estrogens (Premarin) with medroxyprogesterone acetate or conjugated estrogens alone." Am J Obstet Gynecol 170 (1994): 1213-23
  31. Mishell DR "Contraception." N Engl J Med 320 (1989): 777-85
  32. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  33. Lavecchia C, Negri E, Franceschi S, Talamini R, Amadori D, Filiberti R, Conti E, Montella M, Veronesi A, Parazzini F, Ferraroni M "Oral contraceptives and breast cancer: a cooperative italian study." Int J Cancer 60 (1995): 163-7
  34. Colditz GA, Hankinson SE, Hunter DJ, et al. "The use of estrogens and progestins and the risk of breast cancer in postmenopausal women." N Engl J Med 332 (1995): 1589-93
  35. Stanford JL, Weiss NS, Voigt LF, Daling JR, Habel LA, Rossing MA "Combined estrogen and progestin hormone replacement therapy in relation to risk of breast cancer in middle-aged women." JAMA 274 (1995): 137-42
  36. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  37. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  38. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  39. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  40. The Writing Group for the PEPI Trial "Effects of hormone replacement therapy on endometrial histology in postmenopausal women." JAMA 275 (1996): 370-5
  41. Zondervan KT, Carpenter LM, Painter R, Vessey MP "Oral contraceptives and cervical cancer - further findings from the oxford family planning association contraceptive study." Br J Cancer 73 (1996): 1291-7
  42. Calle EE, Heath CW, Miraclemcmahill HL, Coates RJ, Liff JM, Franceschi S, Talamini R, Chantarakul N, Koetsawang S, Rachawat D "Breast cancer and hormonal contraceptives: further results." Contraception 54 (suppl (1996): s1-106
  43. Rettig BA, Lemon HM "Cancers related to contraceptive use." Br J Cancer 74 (1996): 1509-10
  44. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  45. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  46. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  47. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  48. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  49. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  50. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  51. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  52. Greendale GA, Reboussin BA, Sie A, et al. "Effects of estrogen and estrogen-progestin on mammographic parenchymal density." Ann Intern Med 130 (1999): 262-9
  53. Gapstur SM, Morrow M, Sellers TA "Hormone replacement therapy and risk of breast cancer with a favorable histology: results of the Iowa women's health study." JAMA 281 (1999): 2091-7
  54. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  55. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  56. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  57. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  58. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
  59. "Product Information. Intrarosa (prasterone)." Theramex Australia Pty Ltd 1 (2023):
View all 59 references
Major

Estrogens (applies to Aurovela Fe 1.5/30) hypercalcemia in breast cancer

Major Potential Hazard, Moderate plausibility.

When treated with an estrogen, patients with breast cancer and bone metastases may develop severe hypercalcemia, in which case the drug should be stopped and measures be taken to reduce serum calcium levels.

References

  1. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  2. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  3. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  4. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  5. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  6. "Product Information. Emcyt (estramustine)." Pharmacia and Upjohn PROD (2001):
  7. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  8. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  9. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  10. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  11. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
View all 11 references
Major

Estrogens (applies to Aurovela Fe 1.5/30) hypertension

Major Potential Hazard, High plausibility.

The risk of myocardial infarction and strokes, including those associated with oral contraceptive use and some estrogen use, is increased in patients with hypertension. Moreover, estrogens (and progestogens) may elevate blood pressure and worsen the hypertension, thus compounding the risk. Clinically significant blood pressure increases have been reported during estrogen therapy, particularly in patients receiving high dosages or treated with oral contraceptive combinations having high progestational activity. These effects also increase with duration of therapy and patient age. Therapy with estrogens should be administered cautiously in patients with preexisting hypertension. Patients should be monitored for changes in cardiovascular status, and their antihypertensive regimen adjusted or estrogen therapy withdrawn as necessary. In patients requiring contraception, alternative methods should be considered for those who are hypertensive, over age 35, and smoke.

References

  1. Leiman G "Depo-medroxyprogesterone acetate as a contraceptive agent: its effect on weight and blood pressure." Am J Obstet Gynecol 114 (1972): 97-102
  2. Williams RS "Benefits and risks of oral contraceptive use." Postgrad Med 92 (1992): 155-7
  3. Crane MG, Harris JJ "Estrogens and hypertension: effect of discontinuing estrogens on blood pressure, exchangeable sodium, and the renin-aldosterone system." Am J Med Sci 276 (1978): 33-55
  4. Crane MG, Harris JJ, Winsor W 3d "Hypertension, oral contraceptive agents, and conjugated estrogens." Ann Intern Med 74 (1971): 13-21
  5. Rosenberg L, Slone D, Shapiro S, Kaufman D, Stolley PD, Miettinen OS "Noncontraceptive estrogens and myocardial infarction in young women." JAMA 244 (1980): 339-42
  6. Jick H, Dinan B, Rothman KJ "Noncontraceptive estrogens and nonfatal myocardial infarction." JAMA 239 (1978): 1407-8
  7. Wren BG, Routledge DA "Blood pressure changes: oestrogens in climacteric women." Med J Aust 2 (1981): 528-31
  8. Rosenberg L, Palmer JR, Lesko SM, Shapiro S "Oral contraceptive use and the risk of myocardial infarction." Am J Epidemiol 131 (1990): 1009-16
  9. Thorogood M, Mann J, Murphy M, Vessey M "Fatal stroke and use of oral contraceptives: findings from a case- control study." Am J Epidemiol 136 (1992): 35-45
  10. Leaf DA, Bland D, Schaad D, Neighbor WE, Scott CS "Oral contraceptive use and coronary risk factors in women." Am J Med Sci 301 (1991): 365-8
  11. Thorneycroft IH "Oral contraceptives and myocardial infarction." Am J Obstet Gynecol 163 (1990): 1393-7
  12. Lidegaard O "Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study." BMJ 306 (1993): 956-63
  13. Derman RJ "Oral contraceptives and cardiovascular risk. Taking a safe course of action." Postgrad Med 88 (1990): 119-22
  14. Hannaford PC, Croft PR, Kay CR "Oral contraception and stroke. Evidence from the Royal College of General Practitioners' Oral Contraception Study." Stroke 25 (1994): 935-42
  15. Steinberg WM "Oral contraception: risks and benefits." Adv Contracept 5 (1989): 219-28
  16. Peterson HB, Lee NC "Long-term health risks and benefits of oral contraceptive use." Obstet Gynecol Clin North Am 17 (1990): 775-88
  17. Derman R "Oral contraceptives: a reassessment." Obstet Gynecol Surv 44 (1989): 662-8
  18. Belchetz PE "Hormonal treatment of postmenopausal women." N Engl J Med 330 (1994): 1062-71
  19. Stampfer MJ, Colditz GA, Willett WC, et al. "Postmenopausal estrogen and cardiovascular disease. Ten-year follow-up from the Nurses' Health Study." N Engl J Med 325 (1991): 756-62
  20. Barrett-Connor E, Bush TL "Estrogen and coronary heart disease in women." JAMA 265 (1991): 1861-7
  21. Barrett-Connor E, Wingard DL, Criqui MH "Postmenopausal estrogen use and heart disease risk factors in the 1980s. Rancho Bernardo, Calif, revisited." JAMA 261 (1989): 1095-2100
  22. Mishell DR "Contraception." N Engl J Med 320 (1989): 777-85
  23. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  24. Schwartz J, Freeman R, Frishman W "Clinical pharmacology of estrogens: cardiovascular actions and cardioprotective benefits of replacement therapy in postmenopausal women." J Clin Pharmacol 35 (1995): 1-16
  25. The Writing Group for the PEPI Trial "Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial." JAMA 273 (1995): 199-208
  26. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  27. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  28. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  29. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  30. Norris LA, Bonnar J "The effect of oestrogen dose and progestogen type on haemostatic changes in women taking low dose oral contraceptives." Br J Obstet Gynaecol 103 (1996): 261-7
  31. Levine AB, Teppa J, Mcgough B, Cowchock FS "Evaluation of the prethrombotic state in pregnancy and in women using oral contraceptives." Contraception 53 (1996): 255-7
  32. Petitti DB, Sidney S, Bernstein A, Wolf S, Quesenberry C, Ziel HK "Stroke in users of low-dose oral contraceptives." N Engl J Med 335 (1996): 8-15
  33. Speroff L "Oral contraceptives and venous thromboembolism." Int J Gynaecol Obstet 54 (1996): 45-50
  34. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG, Debertribeiro M, Medina E, Artigas J, Shen H, Zhong YH, Zhang DW, "Ischaemic stroke and combined oral contraceptives: results of an international, multicentre, case-control study." Lancet 348 (1996): 498-505
  35. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG "Haemorrhagic stroke, overall stroke risk, and combined oral contraceptives: results of an international, multicentre, case-control study." Lancet 348 (1996): 505-10
  36. Piegsa K, Guillebaud J "Oral contraceptives and the risk of DVT." Practitioner 240 (1996): 544
  37. Martinelli I, Rosendaal FR, Vandenbroucke JP, Mannucci PM "Oral contraceptives are a risk factor for cerebral vein thrombosis." Thromb Haemost 76 (1996): 477-8
  38. Farley TMM, Meirik O, Poulter NR, Chang CL, Marmot MG "Oral contraceptives and thrombotic diseases: impact of new epidemiological studies." Contraception 54 (1996): 193-5
  39. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  40. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  41. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  42. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  43. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  44. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  45. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  46. Sidney S, Petitti DB, Quesenberry CP "Myocardial infarction and the use of estrogen and estrogen-progestogen in postmenopausal women." Ann Intern Med 127 (1997): 501-8
  47. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  48. Thorogood M "Risk of stroke in users of oral contraceptives." JAMA 281 (1999): 1255-6
  49. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  50. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  51. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  52. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  53. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 53 references
Major

Estrogens (applies to Aurovela Fe 1.5/30) thromboembolism/cardiovascular

Major Potential Hazard, Moderate plausibility. Applicable conditions: Migraine, History - Thrombotic/Thromboembolic Disorder, Cerebral Vascular Disorder, Thrombotic/Thromboembolic Disorder, Ischemic Heart Disease

The use of estrogens is considered by manufacturers and some authorities to be contraindicated in patients with active thrombotic or thromboembolic disorders. The use of estrogen-containing oral contraceptives is additionally deemed contraindicated in patients with a history of such disorders and/or current cerebrovascular or coronary artery disease. Females with a history of migraines with aura are at an increased risk for stroke and this stroke risk may be further increased in females who have migraines with aura with use of combination oral contraceptives. Hypercoagulability and changes in various clotting factors and blood components have been observed in women receiving estrogen therapy. Although the clinical significance of these effects is unknown, epidemiological data suggest it may be dose-dependent. The risk is probably slight with the use of newer, low-dose oral contraceptives in the absence of known risk factors (e.g., smoker, particularly over the age of 35; hypertension; hyperlipidemia; obesity; diabetes; age over 40). However, a much more significant risk has been reported with higher dosages, such as those used to treat prostate or metastatic breast cancer or those used in older formulations of birth control pills. Therapy with estrogens should be administered cautiously in the lowest effective dosage and only after careful consideration of risks and benefits. Estrogens should be avoided in patients with a history of thrombotic and thromboembolic disorders associated with estrogen use, except when used in the treatment of breast or prostatic malignancy.

References

  1. Notelovitz M "Oral contraception and coagulation." Clin Obstet Gynecol 28 (1985): 73-83
  2. Meade TW "Oral contraceptives, clotting factors, and thrombosis." Am J Obstet Gynecol 142 (1982): 758-61
  3. Williams RS "Benefits and risks of oral contraceptive use." Postgrad Med 92 (1992): 155-7
  4. Rosenberg L, Slone D, Shapiro S, Kaufman D, Stolley PD, Miettinen OS "Noncontraceptive estrogens and myocardial infarction in young women." JAMA 244 (1980): 339-42
  5. Jick H, Dinan B, Rothman KJ "Noncontraceptive estrogens and nonfatal myocardial infarction." JAMA 239 (1978): 1407-8
  6. Boschetti C, Cortellaro M, Nencioni T, Bertolli V, Della Volpe A, Zanussi C "Short- and long-term effects of hormone replacement therapy (transdermal estradiol vs oral conjugated equine estrogens, combined with medroxyprogesterone acetate) on blood coagulation factors in postmenopausal women." Thromb Res 62 (1991): 1-8
  7. Rosenberg L, Palmer JR, Lesko SM, Shapiro S "Oral contraceptive use and the risk of myocardial infarction." Am J Epidemiol 131 (1990): 1009-16
  8. Thorogood M, Mann J, Murphy M, Vessey M "Fatal stroke and use of oral contraceptives: findings from a case- control study." Am J Epidemiol 136 (1992): 35-45
  9. Leaf DA, Bland D, Schaad D, Neighbor WE, Scott CS "Oral contraceptive use and coronary risk factors in women." Am J Med Sci 301 (1991): 365-8
  10. Thorneycroft IH "Oral contraceptives and myocardial infarction." Am J Obstet Gynecol 163 (1990): 1393-7
  11. Lidegaard O "Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study." BMJ 306 (1993): 956-63
  12. Derman RJ "Oral contraceptives and cardiovascular risk. Taking a safe course of action." Postgrad Med 88 (1990): 119-22
  13. Hannaford PC, Croft PR, Kay CR "Oral contraception and stroke. Evidence from the Royal College of General Practitioners' Oral Contraception Study." Stroke 25 (1994): 935-42
  14. Steinberg WM "Oral contraception: risks and benefits." Adv Contracept 5 (1989): 219-28
  15. Miwa LJ, Edmunds AL, Shaefer MS, Raynor SC "Idiopathic thromboembolism associated with triphasic oral contraceptives." DICP 23 (1989): 773-5
  16. Beaumont V, Lemort N, Beaumont JL "Oral contraceptives, sex steroid-induced antibodies and vascular thrombosis: results from 1318 cases." Eur Heart J 12 (1991): 1219-24
  17. Key JD, Hammill WW, Everett L "Pulmonary embolus in an adolescent on oral contraceptives." J Adolesc Health 13 (1992): 713-5
  18. Burkman RT Jr "Benefits and risk of oral contraceptives. A reassessment." J Reprod Med 36 (1991): 217-8
  19. Peterson HB, Lee NC "Long-term health risks and benefits of oral contraceptive use." Obstet Gynecol Clin North Am 17 (1990): 775-88
  20. Boston Collaborative Drug Surveilance Program "Surgically confirmed gallbladder disease, venous thromboembolism, and breast tumors in relation to postmenopausal estrogen therapy." N Engl J Med 290 (1974): 15-9
  21. Belchetz PE "Hormonal treatment of postmenopausal women." N Engl J Med 330 (1994): 1062-71
  22. Devor M, Barrett-Connor E, Renvall M, Feigal D, Ramsdell J "Estrogen replacement therapy and the risk of venous thrombosis." Am J Med 92 (1992): 275-81
  23. Barrett-Connor E, Bush TL "Estrogen and coronary heart disease in women." JAMA 265 (1991): 1861-7
  24. Grady D, Rubin SM, Petiti DB, et al. "Hormone therapy to prevent disease and prolong life in postmenopausal women." Ann Intern Med 117 (1992): 1016-36
  25. Barrett-Connor E, Wingard DL, Criqui MH "Postmenopausal estrogen use and heart disease risk factors in the 1980s. Rancho Bernardo, Calif, revisited." JAMA 261 (1989): 1095-2100
  26. Mishell DR "Contraception." N Engl J Med 320 (1989): 777-85
  27. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  28. Schwartz J, Freeman R, Frishman W "Clinical pharmacology of estrogens: cardiovascular actions and cardioprotective benefits of replacement therapy in postmenopausal women." J Clin Pharmacol 35 (1995): 1-16
  29. Lidegaard O "Oral contraceptives, pregnancy and the risk of cerebral thromboembolism: the influence of diabetes, hypertension, migraine and previous thrombotic disease." Br J Obstet Gynaecol 102 (1995): 153-9
  30. The Writing Group for the PEPI Trial "Effects of estrogen or estrogen/progestin regimens on heart disease risk factors in postmenopausal women: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial." JAMA 273 (1995): 199-208
  31. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  32. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  33. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  34. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  35. Norris LA, Bonnar J "The effect of oestrogen dose and progestogen type on haemostatic changes in women taking low dose oral contraceptives." Br J Obstet Gynaecol 103 (1996): 261-7
  36. Levine AB, Teppa J, Mcgough B, Cowchock FS "Evaluation of the prethrombotic state in pregnancy and in women using oral contraceptives." Contraception 53 (1996): 255-7
  37. Petitti DB, Sidney S, Bernstein A, Wolf S, Quesenberry C, Ziel HK "Stroke in users of low-dose oral contraceptives." N Engl J Med 335 (1996): 8-15
  38. Speroff L "Oral contraceptives and venous thromboembolism." Int J Gynaecol Obstet 54 (1996): 45-50
  39. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG, Debertribeiro M, Medina E, Artigas J, Shen H, Zhong YH, Zhang DW, "Ischaemic stroke and combined oral contraceptives: results of an international, multicentre, case-control study." Lancet 348 (1996): 498-505
  40. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG "Haemorrhagic stroke, overall stroke risk, and combined oral contraceptives: results of an international, multicentre, case-control study." Lancet 348 (1996): 505-10
  41. Piegsa K, Guillebaud J "Oral contraceptives and the risk of DVT." Practitioner 240 (1996): 544
  42. Martinelli I, Rosendaal FR, Vandenbroucke JP, Mannucci PM "Oral contraceptives are a risk factor for cerebral vein thrombosis." Thromb Haemost 76 (1996): 477-8
  43. Farley TMM, Meirik O, Poulter NR, Chang CL, Marmot MG "Oral contraceptives and thrombotic diseases: impact of new epidemiological studies." Contraception 54 (1996): 193-5
  44. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  45. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  46. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  47. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  48. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  49. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  50. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  51. Sidney S, Petitti DB, Quesenberry CP "Myocardial infarction and the use of estrogen and estrogen-progestogen in postmenopausal women." Ann Intern Med 127 (1997): 501-8
  52. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E "Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women." JAMA 280 (1998): 605-13
  53. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  54. Petitti DB "Hormone replacement therapy and heart disease prevention: experimentation trumps observation." JAMA 280 (1998): 650-2
  55. Thorogood M "Risk of stroke in users of oral contraceptives." JAMA 281 (1999): 1255-6
  56. Mendelsohn ME, Karas RH "The protective effects of estrogen on the cardiovascular system." N Engl J Med 340 (1999): 1801-11
  57. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  58. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  59. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  60. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  61. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
  62. "Product Information. Intrarosa (prasterone)." Theramex Australia Pty Ltd 1 (2023):
View all 62 references
Major

Estrogens/progestogens (applies to Aurovela Fe 1.5/30) hepatic neoplasms

Major Potential Hazard, High plausibility. Applicable conditions: Hepatic Tumor, Hepatic Tumor

The use of oral contraceptives is contraindicated in patients with liver tumors. An increased risk of benign hepatic adenomas and hepatocellular carcinomas has been associated with long-term, oral estrogen- progestin contraceptive use of at least 4 years and 8 years, respectively. Although these tumors are rare and have not been reported with other types of estrogen or progestogen therapies, any preparation containing estrogens and/or progestogens should probably be avoided in patients with existing tumors of the liver. Hepatic hemangiomas and nodular hyperplasia of the liver have been reported with isolated estrogen therapy.

References

  1. Tao LC "Oral contraceptive-associated liver cell adenoma and hepatocellular carcinoma." Cancer 68 (1991): 341-7
  2. "Depot-medroxyprogesterone acetate (DMPA) and risk of liver cancer. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives." Int J Cancer 49 (1991): 182-5
  3. Conter RL, Longmire WP Jr "Recurrent hepatic hemangiomas. Possible association with estrogen therapy." Ann Surg 207 (1988): 115-9
  4. Aldinger K, Ben-Menachem Y, Whalen G "Focal nodular hyperplasia of the liver associated with high-dosage estrogens." Arch Intern Med 137 (1977): 357-9
  5. Palmer JR, Rosenberg L, Kaufman DW, Warshauer ME, Stolley P, Shapiro S "Oral contraceptive use and liver cancer." Am J Epidemiol 130 (1989): 878-82
  6. Mooney MJ, Nyreen MR, Hall RA, Carter PL "Hepatic adenoma presenting as a right lower quadrant mass." Am Surg 59 (1993): 229-31
  7. Gyorffy EJ, Bredfeldt JE, Black WC "Transformation of hepatic cell adenoma to hepatocellular carcinoma due to oral contraceptive use." Ann Intern Med 110 (1989): 489-90
  8. Tavani A, Negri E, Parazzini F, Franceschi S, La Vecchia C "Female hormone utilisation and risk of hepatocellular carcinoma." Br J Cancer 67 (1993): 635-7
  9. Mathieu D, Zafrani ES, Anglade MC, Dhumeaux D "Association of focal nodular hyperplasia and hepatic hemangioma." Gastroenterology 97 (1989): 154-7
  10. Le Bail B, Jouhanole H, Deugnier Y, Salame G, Pellegrin JL, Saric J, Balabaud C, Bioulac-Sage P "Liver adenomatosis with granulomas in two patients on long-term oral contraceptives." Am J Surg Pathol 16 (1992): 982-7
  11. "Oral contraceptives and neoplasia. WHO Scientific Group." World Health Organ Tech Rep Ser 817 (1992): 1-46
  12. Mishell DR "Contraception." N Engl J Med 320 (1989): 777-85
  13. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  14. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  15. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  16. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  17. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  18. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  19. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  20. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  21. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  22. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  23. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  24. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  25. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  26. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  27. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  28. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  29. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  30. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  31. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  32. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  33. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals (2006):
  34. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 34 references
Major

Progestogens (applies to Aurovela Fe 1.5/30) breast malignancy

Major Potential Hazard, High plausibility. Applicable conditions: Breast Cancer

The use of progestogens is considered by manufacturers to be contraindicated in patients with existing or suspected malignancy of the breast. Some supportive data are available for medroxyprogesterone. Specifically, medroxyprogesterone treatment may be associated with breast cancer, primarily when the drug is administered intramuscularly. A pooled analysis of two case-control studies, one from the World Health Organization and the other from New Zealand, revealed a small overall relative risk of breast cancer in women who have ever used intramuscular medroxyprogesterone acetate. The relative risk was higher in the subgroup of women who had initiated therapy within the previous 5 years. Thus, an increased risk (approximately 2-fold) is associated with intramuscular medroxyprogesterone use in the first 5 years. A more recent U.S. study also found a statistically significant increase in breast cancer risk among recent users (defined as last use within the past five years) who used depo-medroxyprogesterone acetate for 12 months or longer.

References

  1. Liang AP, Levenson AG, Layde PM, Shelton JD, Hatcher RA, Potts M, Michelson MJ "Risk of breast, uterine corpus, and ovarian cancer in women receiving medroxyprogesterone injections." JAMA 249 (1983): 2909-12
  2. "Breast cancer, cervical cancer, and depot medroxyprogesterone acetate. WHO Collaborative Study of Neoplasia and Steroid Contraceptives" Lancet 2 (1984): 1207-8
  3. "Breast cancer and depot-medroxyprogesterone acetate: a multinational study. WHO Collaborative Study of Neoplasia and Steroid Contraceptives" Lancet 338 (1991): 833-8
  4. Jordan A "Toxicology of depot medroxyprogesterone acetate." Contraception 49 (1994): 189-201
  5. Chilvers C "Breast cancer and depot-medroxyprogesterone acetate - a review." Contraception 49 (1994): 211-22
  6. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  7. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  8. Skegg DC, Noonan EA, Paul C, Spears GF, Meirik O, Thomas DB "Depot medroxyprogesterone acetate and breast cancer." JAMA 273 (1995): 799-807
  9. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  10. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  11. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  12. "Product Information. Prometrium (progesterone)." Virtus Pharmaceuticals LLC PROD (2001):
  13. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals (2006):
View all 13 references
Major

Progestogens (applies to Aurovela Fe 1.5/30) liver disease

Major Potential Hazard, High plausibility.

The use of progestogens, in general, is contraindicated in patients with impaired hepatic function or liver disease. There are little or no data concerning the pharmacokinetic disposition of the different progestogens in patients with hepatic disease. However, most hormones, including progestational hormones, are known to be extensively metabolized by the liver. Medroxyprogesterone should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur.

References

  1. Utaaker E, Lundgren S, Kvinnsland S, Aakvaag A "Pharmacokinetics and metabolism of medroxyprogesterone acetate in patients with advanced breast cancer." J Steroid Biochem 31 (1988): 437-41
  2. Castegnaro E, Sala G "Pharmacokinetics and metabolism of medroxyprogesterone acetate. Influence of the route of administration and of its physical state." Steroidologia 2 (1971): 13-26
  3. Riippa P, Kauppila A, Sundstrom H, Vihko R "Hepatic impairment during simultaneous administration of medroxyprogesterone acetate and tamoxifen in the treatment of endometrial and ovarian carcinoma." Anticancer Res 4 (1984): 109-12
  4. Meyer WJ, 3d Wiener I, Emory LE, Cole CM, Isenberg N, Fagan CJ, Thompson JC "Cholelithiasis associated with medroxyprogesterone acetate therapy in men." Res Commun Chem Pathol Pharmacol 75 (1992): 69-84
  5. Hendeles SM, Galand N, Schwers J "Metabolism of orally administered D-norgestrel in women." Acta Endocrinol (Copenh) 71 (1972): 557-68
  6. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  7. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  8. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  9. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  10. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  11. "Product Information. Prometrium (progesterone)." Virtus Pharmaceuticals LLC PROD (2001):
  12. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals (2006):
View all 12 references
Major

Progestogens (applies to Aurovela Fe 1.5/30) thromboembolism

Major Potential Hazard, Moderate plausibility. Applicable conditions: Cerebral Vascular Disorder, History - Thrombotic/Thromboembolic Disorder, Thrombotic/Thromboembolic Disorder

The use of progestogens, in general, is considered by manufacturers to be contraindicated in patients with active thrombophlebitis, cerebrovascular disease, or a current or past history of thromboembolic disorders. While the role of progestogens in the development of thromboembolic events associated with hormonal therapy is often unclear and thought to be secondary to that of estrogens, it may not be insignificant. Medroxyprogesterone, a common progestational agent, has been shown to produce a hypercoagulable state in high dosages. Whether or not this effect contributes to the development of thrombotic events is unknown. However, thrombophlebitis and pulmonary embolism have been reported with megestrol, an antineoplastic and progestational agent. In addition, an increased risk of nonfatal venous thrombosis has been associated with oral contraceptive combinations containing desogestrel or gestodene relative to those that contain other progestins (e.g., levonorgestrel, norethindrone), suggesting some degree of hemostatic effect by progestogens.

References

  1. Astedt B, Jeppsson S, Pandolfi M "Fibrinolytic activity of veins during use of depot medroxyprogesterone acetate as a contraceptive." Fertil Steril 23 (1972): 489-92
  2. Yamamoto H, Noguchi S, Miyauchi K, Inaji H, Imaoka S, Koyama H, Iwanaga T "Changes in hematologic parameters during treatment with medroxyprogesterone acetate for breast cancer." Jpn J Cancer Res 82 (1991): 420-5
  3. Fukutomi T, Nanasawa T, Yamamoto H, Adachi I, Watanabe T "The induction of a hypercoagulable state by medroxyprogesterone acetate in breast cancer patients." Jpn J Surg 20 (1990): 665-70
  4. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  5. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  6. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  7. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  8. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  9. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  10. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  11. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  12. "Product Information. Megace (megestrol)." Bristol-Myers Squibb PROD (2001):
  13. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  14. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  15. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  16. "Product Information. Prometrium (progesterone)." Virtus Pharmaceuticals LLC PROD (2001):
  17. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals (2006):
View all 17 references
Moderate

Estrogens (applies to Aurovela Fe 1.5/30) angioedema

Moderate Potential Hazard, Moderate plausibility.

The use of exogenous estrogens may induce or exacerbate symptoms of angioedema, particularly in women with hereditary angioedema. Close monitoring is recommended when prescribing these agents to patients predisposed to angioedema.

References

  1. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  2. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  3. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  4. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  5. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  6. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  7. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 7 references
Moderate

Estrogens (applies to Aurovela Fe 1.5/30) gallbladder disease

Moderate Potential Hazard, Moderate plausibility.

A two- to four-fold increase in risk of gallbladder disease has been noted in women receiving postmenopausal estrogen therapy. The risk for gallbladder disease may be less for premenopausal women using oral contraceptives containing low-dose estrogens and/or progestins. Therapy with estrogens should be administered cautiously in patients with preexisting gallbladder disease.

References

  1. Boston Collaborative Drug Surveilance Program "Surgically confirmed gallbladder disease, venous thromboembolism, and breast tumors in relation to postmenopausal estrogen therapy." N Engl J Med 290 (1974): 15-9
  2. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  3. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  4. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  5. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  6. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  7. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  8. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  9. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  10. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  11. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  12. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  13. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  14. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  15. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  16. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  17. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  18. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  19. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 19 references
Moderate

Estrogens (applies to Aurovela Fe 1.5/30) hypercalcemia

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Hyperparathyroidism, Renal Dysfunction

Estrogens influence the metabolism of calcium and phosphorus. Intestinal absorption and retention of calcium are increased, which may occasionally result in hypercalcemia. Therapy with estrogens should be administered cautiously in patients with preexisting hypercalcemia, renal dysfunction, or metabolic bone diseases that are associated with hypercalcemia.

References

  1. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  2. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  3. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  4. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  5. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  6. "Product Information. Emcyt (estramustine)." Pharmacia and Upjohn PROD (2001):
  7. "Product Information. Duavee (bazedoxifene-conjugated estrogens)." Pfizer U.S. Pharmaceuticals Group (2013):
View all 7 references
Moderate

Estrogens (applies to Aurovela Fe 1.5/30) hyperlipidemia

Moderate Potential Hazard, Moderate plausibility.

Although estrogens have generally favorable effects on plasma lipids, including increases in HDL and decreases in total cholesterol and LDL, they have also been associated with significant elevations in triglyceride levels, particularly when high dosages are used. Severe hyperlipidemia is known to sometimes cause pancreatitis. Patients with preexisting hyperlipidemia may require closer monitoring during estrogen therapy, and adjustments made accordingly in their lipid-lowering regimen.

References

  1. Molitch ME, Oill P, Odell WD "Massive hyperlipemia during estrogen therapy." JAMA 227 (1974): 522-5
  2. Janaud A, Rouffy J, Upmalis D, Dain MP "A comparison study of lipid and androgen metabolism with triphasic oral contraceptive formulations containing norgestimate or levonorgestrel." Acta Obstet Gynecol Scand Suppl 156 (1992): 33-8
  3. Steinberg WM "Oral contraception: risks and benefits." Adv Contracept 5 (1989): 219-28
  4. Burkman RT, Zacur HA, Kimball AW, Kwiterovich P, Bell WR "Oral contraceptives and lipids and lipoproteins: Part I--Variations in mean levels by oral contraceptive type." Contraception 40 (1989): 553-61
  5. Derman R "Oral contraceptives: a reassessment." Obstet Gynecol Surv 44 (1989): 662-8
  6. Godsland IF, Crook D "Update on the metabolic effects of steroidal contraceptives and their relationship to cardiovascular disease risk." Am J Obstet Gynecol 170 (1994): 1528-36
  7. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  8. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  9. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  10. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  11. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  12. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  13. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  14. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  15. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  16. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  17. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  18. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  19. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E "Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women." JAMA 280 (1998): 605-13
  20. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  21. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  22. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  23. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  24. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  25. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 25 references
Moderate

Estrogens (applies to Aurovela Fe 1.5/30) liver disease

Moderate Potential Hazard, High plausibility.

Estrogens are primarily metabolized by the liver. Patients with impaired hepatic function may be at increased risk for adverse effects associated with estrogen administration due to decreased drug clearance. Therapy with estrogens should be administered cautiously in patients with liver disease. In addition, clinicians should be aware that estrogen therapy may affect liver function tests. Increased sulfobromophthalein retention has been reported with the use of estrogen-containing oral contraceptives and may be expected with larger doses of estrogens.

References

  1. Bhavnani BR, Cecutti A "Pharmacokinetics of 17 beta-dihydroequilin sulfate and 17 beta- dihydroequilin in normal postmenopausal women." J Clin Endocrinol Metab 78 (1994): 197-204
  2. Adlercrueuta H "Hepatic metabolism of estrogens in health and disease." N Engl J Med 290 (1974): 1081-3
  3. Goldzieher JW "Pharmacology of contraceptive steroids: a brief review." Am J Obstet Gynecol 160 (1989): 1260-4
  4. Kuhnz W, al-Yacoub G, Fuhrmeister A "Pharmacokinetics of levonorgestrel and ethinylestradiol in 9 women who received a low-dose oral contraceptive over a treatment period of 3 months and the same contraceptive formulation." Contraception 46 (1992): 455-69
  5. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  6. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  7. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  8. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  9. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  10. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  11. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  12. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  13. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  14. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  15. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  16. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  17. "Product Information. Emcyt (estramustine)." Pharmacia and Upjohn PROD (2001):
  18. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  19. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  20. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  21. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  22. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  23. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 23 references
Moderate

Estrogens (applies to Aurovela Fe 1.5/30) melasma

Moderate Potential Hazard, Moderate plausibility.

The use of exogenous estrogens may occasionally cause chloasma, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking combination oral contraceptives.

References

  1. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  2. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  3. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  4. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  5. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  6. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  7. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 7 references
Moderate

Estrogens/progestogens (applies to Aurovela Fe 1.5/30) depression

Moderate Potential Hazard, Moderate plausibility.

The use of oral contraceptives has been associated with an increased incidence of depression. It is uncertain whether this effect is related to the estrogenic or the progestogenic component of the contraceptive, although excess progesterone activity is associated with depression. Patients with a history of depression receiving estrogen and/or progestogen therapy should be followed closely. The manufacturer of medroxyprogesterone recommends monitoring patients who have a history of depression and to not re- administer medroxyprogesterone if depression recurs.

References

  1. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  2. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  3. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  4. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  5. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  6. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  7. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  8. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  9. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  10. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  11. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  12. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  13. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  14. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  15. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  16. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  17. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  18. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  19. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  20. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  21. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  22. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  23. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals (2006):
  24. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 24 references
Moderate

Estrogens/progestogens (applies to Aurovela Fe 1.5/30) fluid retention

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Migraine, Asthma, Seizures, Congestive Heart Failure, Renal Dysfunction, Congestive Heart Failure, Migraine, Renal Dysfunction, Seizures, Asthma, Hypertension

Estrogens and progestogens may cause fluid retention, particularly when given in high dosages or for prolonged periods. Therapy with these agents should be administered cautiously in patients who have preexisting problems with excess fluid. In addition, patients with conditions that may be adversely affected by fluid accumulation, such as asthma, epilepsy, migraine, and cardiovascular or renal dysfunction, should be observed for exacerbation of their condition during estrogen and/or progestogen therapy.

References

  1. Leiman G "Depo-medroxyprogesterone acetate as a contraceptive agent: its effect on weight and blood pressure." Am J Obstet Gynecol 114 (1972): 97-102
  2. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  3. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  4. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  5. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  6. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  7. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  8. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  9. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  10. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  11. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  12. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  13. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  14. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  15. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  16. "Product Information. Emcyt (estramustine)." Pharmacia and Upjohn PROD (2001):
  17. "Product Information. Megace (megestrol)." Bristol-Myers Squibb PROD (2001):
  18. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  19. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  20. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  21. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  22. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  23. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  24. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  25. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  26. "Product Information. Prometrium (progesterone)." Virtus Pharmaceuticals LLC PROD (2001):
  27. "Product Information. Implanon (etonogestrel)." Organon Pharmaceuticals (2006):
View all 27 references
Moderate

Estrogens/progestogens (applies to Aurovela Fe 1.5/30) glucose intolerance

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Diabetes Mellitus, Diabetes Mellitus

Impaired glucose tolerance has been observed in some patients administered oral contraceptives and appears to be related primarily to the estrogen dose. However, progestogens can increase insulin secretion and produce insulin resistance to varying degrees, depending on the agent. Patients with diabetes mellitus should be monitored more closely during therapy with estrogens and/or progestogens, and adjustments made accordingly in their antidiabetic regimen.

References

  1. Haiba NA, el-Habashy MA, Said SA, Darwish EA, Abdel-Sayed WS, Nayel SE "Clinical evaluation of two monthly injectable contraceptives and their effects on some metabolic parameters." Contraception 39 (1989): 619-32
  2. Virutamasen P, Wongsrichanalai C, Tangkeo P, Nitichai Y, Rienprayoon D "Metabolic effects of depot-medroxyprogesterone acetate in long-term users: a cross-sectional study." Int J Gynaecol Obstet 24 (1986): 291-6
  3. Who Task Force on Long-acting Agents for Fertility Regulation "Metabolic side-effects of injectable depot-medroxyprogesterone acetate, 150 mg three-monthly, in undernourished lactating women." Bull World Health Organ 64 (1986): 587-94
  4. Garg SK, Chase HP, Marshall G, Hoops SL, Holmes DL, Jackson WE "Oral contraceptives and renal and retinal complications in young women with insulin-dependent diabetes mellitus." JAMA 271 (1994): 1099-102
  5. Hannaford PC, Kay CR "Oral contraceptives and diabetes mellitus." BMJ 299 (1989): 1315-6
  6. Stubblefield PG "Choosing the best oral contraceptive." Clin Obstet Gynecol 32 (1989): 316-28
  7. Spellacy WN, Ellingson AB, Tsibris JC "The effects of two triphasic oral contraceptives on carbohydrate metabolism in women during 1 year of use." Fertil Steril 51 (1989): 71-4
  8. Steinberg WM "Oral contraception: risks and benefits." Adv Contracept 5 (1989): 219-28
  9. Derman R "Oral contraceptives: a reassessment." Obstet Gynecol Surv 44 (1989): 662-8
  10. Belchetz PE "Hormonal treatment of postmenopausal women." N Engl J Med 330 (1994): 1062-71
  11. Luciano AA, De Souza MJ, Roy MP, Schoenfeld MJ, Nulsen JC, Halvorson CV "Evaluation of low-dose estrogen and progestin therapy in postmenopausal women." J Reprod Med 38 (1993): 207-14
  12. Kaunitz AM "Long-acting injectable contraception with depot medroxyprogesterone acetate." Am J Obstet Gynecol 170 (1994): 1543-9
  13. "Product Information. Ortho-Novum 1/35 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  14. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  15. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  16. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  17. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  18. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  19. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  20. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  21. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  22. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  23. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  24. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 24 references
Moderate

Estrogens/progestogens (applies to Aurovela Fe 1.5/30) retinal thrombosis

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Visual Defect/Disturbance, Visual Defect/Disturbance

Estrogens and progestogens may cause retinal thrombosis. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Therapy with these agents should be administered cautiously in patients who have preexisting ocular problems and appropriate diagnostic and therapeutic measures should be instituted. Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

References

  1. "Product Information. Ortho-Novum 1/35 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  2. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  3. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  4. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  5. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  6. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  7. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  8. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  9. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  10. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  11. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  12. "Product Information. Prometrium (progesterone)." Virtus Pharmaceuticals LLC PROD (2001):
  13. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 13 references
Moderate

Estrogens/progestogens (applies to Aurovela Fe 1.5/30) thyroid function tests

Moderate Potential Hazard, Moderate plausibility. Applicable conditions: Thyroid Disease, Thyroid Disease

When administering estrogen and/or progestogen therapy in patients with thyroid disorders, clinicians should be aware that these hormones may affect thyroid function tests. Changes have mostly been reported with the use of combination oral contraceptives. Specifically, thyroid-binding globulin (TBG) may be increased, resulting in elevated circulating total thyroid hormone, as measured by PBI (protein-bound iodine), T4 by column or radioimmunoassay, or T3 by radioimmunoassay. Free T3 resin uptake may be decreased. On the contrary, a decrease in TBG and, consequently, thyroxine concentration, has been reported by the manufacturers of the progestin-only (norethindrone) oral contraceptives.

References

  1. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  2. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  3. "Product Information. Premarin (conjugated estrogens)." Wyeth-Ayerst Laboratories PROD (2001):
  4. "Product Information. Deltasone (prednisone)." Pharmacia and Upjohn PROD (2001):
  5. "Product Information. Climara (estradiol)." Berlex Laboratories PROD (2001):
  6. "Product Information. Estrace (estradiol)." Warner Chilcott Laboratories PROD (2001):
  7. "Product Information. Estraderm (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  8. "Product Information. Vivelle (estradiol)." Ciba-Geigy Pharmaceuticals PROD (2001):
  9. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  10. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  11. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  12. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  13. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  14. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  15. "Product Information. Ortho-Novum 1/50 (mestranol-norethindrone)." Ortho McNeil Pharmaceutical
  16. "Product Information. Emcyt (estramustine)." Pharmacia and Upjohn PROD (2001):
  17. "Product Information. Ortho-Est (estropipate)." Ortho McNeil Pharmaceutical PROD (2001):
  18. "Product Information. Ortho Dienestrol (dienestrol topical)." Ortho McNeil Pharmaceutical PROD
  19. "Product Information. Ogen (estropipate topical)." Pharmacia and Upjohn PROD (2001):
  20. "Product Information. Estinyl (ethinyl estradiol)." Schering Corporation PROD
  21. "Product Information. Estratab (esterified estrogens)." Solvay Pharmaceuticals Inc PROD (2001):
  22. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  23. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  24. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  25. "Product Information. Nextstellis (drospirenone-estetrol)." Mayne Pharma (2021):
View all 25 references
Moderate

Progestogens (applies to Aurovela Fe 1.5/30) hyperlipidemia

Moderate Potential Hazard, Moderate plausibility.

Some progestogenic agents may elevate plasma LDL levels and/or lower HDL levels, although data have been inconsistent. Patients with preexisting hyperlipidemia may require closer monitoring during progestogen therapy, and adjustments made accordingly in their lipid-lowering regimen.

References

  1. Barnes RB, Roy S, Lobo RA "Comparison of lipid and androgen levels after conjugated estrogen or depo-medroxyprogesterone acetate treatment in postmenopausal women." Obstet Gynecol 66 (1985): 216-9
  2. Haiba NA, el-Habashy MA, Said SA, Darwish EA, Abdel-Sayed WS, Nayel SE "Clinical evaluation of two monthly injectable contraceptives and their effects on some metabolic parameters." Contraception 39 (1989): 619-32
  3. Virutamasen P, Wongsrichanalai C, Tangkeo P, Nitichai Y, Rienprayoon D "Metabolic effects of depot-medroxyprogesterone acetate in long-term users: a cross-sectional study." Int J Gynaecol Obstet 24 (1986): 291-6
  4. Teichmann AT, Wander HE, Cremer P, et al. "Medroxyprogesterone acetate and lipid metabolic changes." Arzneimittelforschung 37 (1987): 573-77
  5. Who Task Force on Long-acting Agents for Fertility Regulation "Metabolic side-effects of injectable depot-medroxyprogesterone acetate, 150 mg three-monthly, in undernourished lactating women." Bull World Health Organ 64 (1986): 587-94
  6. Luciano AA, De Souza MJ, Roy MP, Schoenfeld MJ, Nulsen JC, Halvorson CV "Evaluation of low-dose estrogen and progestin therapy in postmenopausal women." J Reprod Med 38 (1993): 207-14
  7. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  8. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  9. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  10. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  11. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  12. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  13. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  14. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  15. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  16. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  17. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
View all 17 references
Minor

Progestogens (applies to Aurovela Fe 1.5/30) weight gain

Minor Potential Hazard, Moderate plausibility. Applicable conditions: Obesity

Progestogens can cause weight gain, which may be significant (as is the case with parenteral medroxyprogesterone) and undesirable in obese patients attempting to lose weight.

References

  1. Leiman G "Depo-medroxyprogesterone acetate as a contraceptive agent: its effect on weight and blood pressure." Am J Obstet Gynecol 114 (1972): 97-102
  2. Amatayakul K, Sivasomboon B, Thanangkul O "A study of the mechanism of weight gain in medroxyprogesterone acetate users." Contraception 22 (1980): 605-22
  3. "Product Information. Depo-Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  4. "Product Information. Provera (medroxyprogesterone)." Pharmacia and Upjohn PROD (2001):
  5. "Product Information. Ortho-Novum 10/11 (ethinyl estradiol-norethindrone)." Ortho McNeil Pharmaceutical
  6. "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical PROD (2001):
  7. "Product Information. Demulen 1/50 (ethinyl estradiol-ethynodiol)." Searle PROD
  8. "Product Information. Triphasil (ethinyl estradiol-levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  9. "Product Information. Ortho-Cyclen (ethinyl estradiol-norgestimate)." Ortho McNeil Pharmaceutical PROD (2001):
  10. "Product Information. Lo/Ovral (ethinyl estradiol-norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  11. "Product Information. Norplant System (levonorgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
  12. "Product Information. Micronor (norethindrone)." Ortho McNeil Pharmaceutical PROD (2001):
  13. "Product Information. Ovrette (norgestrel)." Wyeth-Ayerst Laboratories PROD (2001):
View all 13 references

Aurovela Fe 1.5/30 drug interactions

There are 458 drug interactions with Aurovela Fe 1.5 / 30 (ethinyl estradiol / norethindrone).

Aurovela Fe 1.5/30 alcohol/food interactions

There are 8 alcohol/food interactions with Aurovela Fe 1.5 / 30 (ethinyl estradiol / norethindrone).


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.