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Acetazolamide Pregnancy and Breastfeeding Warnings

Acetazolamide is also known as: Diamox, Diamox Sequels

Acetazolamide Pregnancy Warnings

Despite widespread usage, there is no evidence of a direct association between acetazolamide and birth defects during human pregnancy. Two cases are noteworthy. In one, a woman who used acetazolamide 750 mg/day for glaucoma during the first and second trimesters gave birth to an infant with sacrococcygeal teratoma. In a second case, a woman who used acetazolamide 500 mg/day for glaucoma throughout pregnancy gave birth to an infant who demonstrated metabolic complications postpartum. These problems included metabolic acidosis, hyperbilirubinemia, hypocalcemia, and hypomagnesemia. The neonate was successfully treated, and was only observed to have mild hypertonicity of the lower limbs at up to eight months of age. Retrospective studies, such as the Collaborative Perinatal Project (CCP), reveal no evidence of a relationship between major or minor categories of defects to the use of acetazolamide. The CPP found 12 of 50,282 monitored mother-child pairs had been exposed to the drug during the first or second trimester. A total of 1,024 pairs were exposed to the drug during pregnancy. None of the 12 and 18 of the 1,024 were observed to have anomalies. The incidence of expected anomalies was 18.06 in the 1,024. Therefore, there is no evidence of teratogenicity associated with the use of acetazolamide from this retrospective study. Physicians are encouraged to register patients before fetal outcome is known (e.g., ultrasound, results of amniocentesis, etc) into the Antiepileptic Drug (AED) Pregnancy Registry at 1-888-233-2334 or 1-888-AED-AED4. This is an ongoing study at the Massachusetts General Hospital/Harvard Medical School. This study is designed to monitor the outcomes of pregnant women exposed to antiepileptic drugs in order to determine which therapies are associated with increased risk.

Acetazolamide has been assigned to pregnancy category C. Animal studies have shown it to be teratogenic (limb defects, axial skeletal and genitourinary malformations). There are no controlled data from human pregnancy. Acetazolamide should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

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Acetazolamide Breastfeeding Warnings

Acetazolamide is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. Acetazolamide is considered compatible with breast-feeding by the American Academy of Pediatrics.

Limited data are available. A single case of a woman who breast-fed while taking acetazolamide SR 1000 mg/day for glaucoma has been reported. Milk acetazolamide levels after 5 days between 1 and 9 hours after a dose ranged from 1.3 to 2.1 mcg/mL, which represented approximately 25% of the maternal serum drug levels. Plasma levels in the nursing infant ranged from 0.2 to 0.6 mcg/mL. No side effects in the nursing infant were observed. In short, limited data suggest that nursing infants are likely to receive only miniscule amounts of acetazolamide, amounts unlikely to result in side effects.

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References for pregnancy information

  1. Worsham GF, Beckman EN, Mitchell EH "Sacrococcygeal teratoma in a neonate: association with maternal use of acetazolamide." JAMA 240 (1978): 251-2
  2. "Product Information. Diamox (acetazolamide)." Lederle Laboratories, Wayne, NJ.
  3. McBride WG "The teratogenic action of drugs." Med J Aust 2 (1963): 689-93
  4. Miller TA, Scott WJ, Jr "Abnormalities in ureter and kidney development in mice given acetazolamide-amiloride or dimethadione (DMO) during embryogenesis." Teratology 46 (1992): 541-50
  5. Merlob P, Litwin A, Mor N "Possible association between acetazolamide administration during pregnancy and metabolic disorders in the newborn." Eur J Obstet Gynecol Reprod Biol 35 (1990): 85-8
  6. Nakatsuka T, Somatsu T, Fuji T "Axial skeletal malformations induced by acetazolamide in rabbits." Teratology 45 (1992): 629-36
  7. Reiss WG, Oles KS "Acetazolamide in the treatment of seizures." Ann Pharmacother 30 (1996): 514-9
  8. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297

References for breastfeeding information

  1. Reiss WG, Oles KS "Acetazolamide in the treatment of seizures." Ann Pharmacother 30 (1996): 514-9
  2. Soderman P, Fagerlund PH, Hartvig C "Acetazolamide excretion into human breast milk." Br J Clin Pharmacol 17 (1984): 599-60
  3. "Product Information. Diamox (acetazolamide)." Lederle Laboratories, Wayne, NJ.

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