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Dicyclomine Pregnancy and Breastfeeding Warnings

Dicyclomine is also known as: Bemote, Bentyl, Bentyl Syrup, Byclomine, Di-Spaz, Dibent, Dicyclocot, Dilomine

Dicyclomine Pregnancy Warnings

Animal studies in rats and rabbits have revealed no evidence of harm to the fetus with this drug. Adequate and well-controlled studies have not been conducted in pregnant women. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B

See references

Dicyclomine Breastfeeding Warnings

Use should be avoided. Excreted into human milk: Yes Excreted into animal milk: Data not available Comments: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

A single case has been reported of a breast-fed 12 day old infant who developed apnea whose mother was receiving dicyclomine. A causal relationship between dicyclomine and apnea could not be confirmed. Similar adverse reactions have occurred with direct administration of dicyclomine to infants.

See references

References for pregnancy information

  1. Williams J, Watkins-Jones R "Dicyclomine: worrying symptoms associated with its use in some small babies." Br Med J (Clin Res Ed) 288 (1984): 901
  2. Huff PS "Safety of drug therapy for nausea and vomiting of pregnancy." J Fam Pract 11 (1980): 969-70
  3. Altman PM "Debendox withdrawn." Med J Aust 140 (1984): 119
  4. Congenital Abnormalities Sub-Committee of the Australian Drug Evaluation Committtee "Debendox in pregnancy." Med J Aust 1 (1980): 197
  5. Miklovich L, van den Berg BJ "An evaluation of the teratogenicity of certain antinauseant drugs." Am J Obstet Gynecol 125 (1976): 244-8
  6. DonnaiD, Harris R "Unusual fetal malformations after antiemetics in early pregnancy." Br Med J 1 (1978): 691-2
  7. Mellor S "Fetal malformation after debendox treatment in early pregnancy." Br Med J 1 (1978): 1055
  8. Patterson DC "Congenital deformities associated with Benedectin." Can Med Assoc J 116 (1977): 1348
  9. "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals, Kansas City, MO.
  10. Morelock S, Hingson R, Kayne H, Dooling E, Zuckerman B, Day N, Alpert JJ, Flowerdew G "Bendectin and fetal development. A study of Boston City Hospital." Am J Obstet Gynecol 142 (1982): 209-13
  11. Golden SM, Perman KI "Bilateral clinical anophthalmia: drugs as potential factors." South Med J 73 (1980): 1404-7
  12. Correy JF, Newman NM "Debendox and limb reduction deformities." Med J Aust 1 (1981): 417-8
  13. Gibson GT, Colley DP, McMichael AJ, Hartshorne JM "Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors: an ongoing prospective study." Med J Aust 1 (1981): 410-4
  14. Mitchell AA "Debendox." Med J Aust 144 (1986): 52
  15. Correy JF, Newman NM "Debendox withdrawn." Med J Aust 140 (1984): 796-7
  16. Maling TJ "Debendox: a statement from the New Zealand Adverse Drug Reactions Committee." N Z Med J 97 (1984): 203-4
  17. Sheffield LJ, Batagol R "The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?" Med J Aust 143 (1985): 143-7
  18. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  19. Gordon I "Debendox." Med J Aust 144 (1986): 51-2
  20. Fleming DM, Knox JD, Crombie DL "Debendox in early pregnancy and fetal malformation." Br Med J (Clin Res Ed) 283 (1981): 99-101
  21. Wheatley D "Treatment of pregnancy sickness." Br J Obstet Gynaecol 84 (1977): 444-7
  22. Cordero JF, Oakley GP Jr "Drug exposure during pregnancy: some epidemiologic considerations." Clin Obstet Gynecol 26 (1983): 418-28
  23. Dickson JH "Congenital deformities associated with bendectin." Can Med Assoc J 117 (1977): 721-2
  24. Smithells RW, Sheppard S "Fetal malformation after debendox treatment in early pregnancy." Br Med J 1 (1978): 1055-6
  25. Harris R, Donnai D "Debendox and the media." Br Med J 280 (1980): 480-1
  26. Harron DW, Griffiths K, Shanks RG "Debendox and congenital malformations in Northern Ireland." Br Med J 281 (1980): 1379-81
  27. Shapiro S, Heinonen OP, Siskind V, Kaufman DW, Monson RR, Slone D "Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score." Am J Obstet Gynecol 128 (1977): 480-5

References for breastfeeding information

  1. "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals, Kansas City, MO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

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