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Nadolol Pregnancy and Breastfeeding Warnings

Nadolol is also known as: Corgard

Nadolol Pregnancy Warnings

One case report in human pregnancy suggests significant risk. A hypertensive mother with kidney disease gave birth to an infant with growth retardation, marked tachypnea, mild hypoglycemia, followed, at age 4.5 hours, by profound bradycardia, slowed respirations, and decreased core body temperature. Although implication of nadolol alone is not possible, the authors believe some or all of the defects may have been caused by nadolol. Because nadolol has a relatively long serum half-life and relatively low serum protein binding, the authors believe that other beta-blockers, if necessary, are probably safer in pregnancy. Data from the Michigan Medicaid Birth Defects Study failed to reveal an association between the use of nadolol and congenital abnormalities, although the data are limited due to the small number of pregnancies with known exposure to the drug (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This study was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 32 were exposed to nadolol at some time during the first trimester, and 54 were exposed to the drug at any time during pregnancy. Of these pregnancies, a single case of cardiovascular defect was observed. This observation did not achieve statistical significance. These data do not support an association between nadolol and birth defects, although conclusions have not been made due to the small number of pregnancies with known exposure to the drug.

Nadolol has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryo- and fetotoxicity in rabbits, but not in rats or hamsters, after dosages 5 to 10 times the maximum recommended human dosage (on a mg per kg basis). There are no controlled data in human pregnancy. Nadolol should only be used when benefit outweighs risk.

See references

Nadolol Breastfeeding Warnings

Nadolol is excreted into human milk. The effect of nadolol on the nursing infant is not known. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A study of 12 normotensive and 7 mildly hypertensive lactating women who were taking nadolol 80 mg daily for 5 to 13 days revealed concentration of nadolol in human milk. The mean ratio of milk to maternal serum nadolol was 4.6 at steady state. The authors estimated that, if a 5 kg nursing infant would consume approximately 1 liter of milk per day (highly unlikely), the infant would receive 2% to 7% of the therapeutic dose that would be recommended for a person of that weight. The plasma clearance of nadolol is not known in infants, however, and is expected to be decreased because of decreased renal function in neonates. The pediatric dose of nadolol is not determined. Because the effects of nadolol on the nursing infant are not known, caution is recommended in the use of nadolol in lactating mothers who nurse. As with other beta-blockers, it is advisable to monitor the nursing infant for signs and symptoms of beta-blockade, such as bradycardia, hypotension, and hypoglycemia, during breast-feeding.

See references

References for pregnancy information

  1. Fox RE, Marx C, Stark AR "Neonatal effects of maternal nadolol therapy." Am J Obstet Gynecol 152 (1985): 1045-6
  2. "Product Information. Corgard (nadolol)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. Devlin RG, Duchin KL, Fleiss PM "Nadolol in human serum and breast milk." Br J Clin Pharmacol 12 (1981): 393-6
  2. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  3. "Product Information. Corgard (nadolol)." Bristol-Myers Squibb, Princeton, NJ.

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