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Hydralazine Pregnancy and Breastfeeding Warnings

Hydralazine is also known as: Apresoline

Hydralazine Pregnancy Warnings

Hydralazine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity after doses 20 to 30 times the maximum recommended daily human dose (on a per kg basis) were given to mice. Teratogenicity was possibly related to hydralazine after doses 10 to 15 times the maximum recommended daily human dose (on a per kg basis) were given to rabbits. There are no controlled data in human pregnancy. Hydralazine should only be given during pregnancy when benefit outweighs risk.

In general, hydralazine has been used extensively and safely for the treatment of maternal hypertension during pregnancy. There are reports of neonatal asymptomatic and symptomatic thrombocytopenia and maternal and fetal lupus-like syndromes. Among 50,282 mother-child pairs monitored in the Collaborative Perinatal Project, 136 instances of the use of hydralazine during pregnancy were found. Of the 136 pairs, eight malformed children were observed at "anytime" during pregnancy (3.8 were expected from the population studied), yielding a standardized relative risk of 2.09. Underlying preeclampsia makes implication of drug therapy alone difficult. Data from the Michigan Medicaid Birth Defects Study (MMBDS) failed to reveal an association between the use of hydralazine and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The MMBDS is a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 40 were exposed to hydralazine at some time during the first trimester, and 341 were exposed to the drug at any time during pregnancy. These data do not support an association between hydralazine and birth defects. However, results of a meta-analysis comprised of randomized controlled trials do not support the use of hydralazine as a first line agent for the treatment of severe hypertension in pregnancy. Compared with other antihypertensives, use of hydralazine was associated with more cesarean sections, placental abruption, maternal oliguria, and maternal side effects such as headache, palpitations, hypotension, and tachycardia.

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Hydralazine Breastfeeding Warnings

In one case report of a woman who was taking hydralazine 50 mg three times a day, the milk to maternal serum concentration ratio was 1.4, indicating concentration of hydralazine in milk. Even so, the amount of drug exposed to the nursing infant is relatively small, and no adverse effects in the nursing infant were observed.

Hydralazine is excreted into human milk. Adverse effects in the nursing infant are unlikely. The American Academy of Pediatrics considers hydralazine to be compatible with breast-feeding; however, some experts recommend against breast-feeding during hydralazine therapy.

See references

References for pregnancy information

  1. Lodeiro JG, Feinstein SJ, Lodeiro SB "Fetal premature atrial contractions associated with hydralazine." Am J Obstet Gynecol 160 (1989): 105-7
  2. "Product Information. Apresoline (hydralazine)." Ciba Pharmaceuticals, Summit, NJ.
  3. Cunningham FG, Gant NF "Management of eclampsia." Semin Perinatol 18 (1994): 103-13
  4. Magee LA, Cham C, Waterman EJ, Ohlsson A, von Dadelszen P "Hydralazine for treatment of severe hypertension in pregnancy: meta-analysis." BMJ 327 (2003): 955
  5. Mabie WC, Gonzalez AR, Sibai BM, Amon E "A comparative trial of labetalol hydralazine in the acute management of severe hypertension complicating pregnancy." Obstet Gynecol 70 (1987): 328-33
  6. Johnson GT, Thompson RB "A clinical trial of intravenous apresoline in the management of toxaemia of late pregnancy." J Obstet Gynaecol 65 (1958): 360-6
  7. Bott-Kanner G, Schwitzer A, Schoenfeld A, Joel-Cohen J, Rosenfeld JB "Treatment with propranolol and hydralazine throughout pregnancy in a hypertensive patient." Isr J Med Sci 14 (1978): 466-8
  8. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  9. Patersonbrown S, Robson SC, Redfern N, Walkinshaw SA, Deswiet M "Hydralazine boluses for the treatment of severe hypertension in pre-eclampsia." Br J Obstet Gynaecol 101 (1994): 409-13
  10. Pritchard JA, Pritchard SA "Standardized treatment of 154 consecutive cases of eclampsia." Am J Obstet Gynecol 123 (1975): 543-52
  11. De Swiet M "Antihypertensive drugs in pregnancy." Br Med J (Clin Res Ed) 291 (1985): 365-6
  12. Yemini M, Shoman (Schwartz) Z, Dgani R, et al. "Lupus-like syndrome in a mother and newborn following administration of hydralazine; a case report." Eur J Obstet Gynecol Reprod Biol 30 (1989): 193-7
  13. Kuzniar J, Skret A, Piela A, Szmigiel Z, Zaczek T "Hemodynamic effects of intravenous hydralazine in pregnant women with severe hypertension." Obstet Gynecol 66 (1985): 453-8
  14. Chapman ER, Strozier WE, Magee RA "The clinical use of apresoline in the toxemias of pregnancy: a preliminary report." Am J Obstet Gynecol 68 (1954): 1109-7
  15. Gudmundsson S, Gennser G, Marsal K "Effects of hydralazine on placental and renal circulation in pre-eclampsia." Acta Obstet Gynecol Scand 74 (1995): 415-8
  16. Rosenfeld J, Bott-Kanner G, Boner G, et al. "Treatment of hypertension during pregnancy with hydralazine monotherapy or with combined therapy with hydralazine and pindolol." Eur J Obstet Gynecol Reprod Biol 22 (1986): 197-204
  17. Widerlov E, Karlman I, Storsater J "Hydralazine-induced neonatal thrombocytopenia." N Engl J Med 303 (1980): 1235
  18. Liedholm H, Wahlin-Boll E, Hanson A, Ingemarsson I, Melander A "Transplacental passage and breast milk concentrations of hydralazine." Eur J Clin Pharmacol 21 (1982): 417-9

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  2. Liedholm H, Wahlin-Boll E, Hanson A, Ingemarsson I, Melander A "Transplacental passage and breast milk concentrations of hydralazine." Eur J Clin Pharmacol 21 (1982): 417-9
  3. "Product Information. Apresoline (hydralazine)." Ciba Pharmaceuticals, Summit, NJ.

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