Propranolol Pregnancy and Breastfeeding Warnings
Propranolol Pregnancy Warnings
Propranolol has been assigned to pregnancy category C by the FDA. Some animal studies using high doses have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy. Propranolol has been given during pregnancy to treat both maternal and fetal conditions without evidence of teratogenicity. However, fetal and neonatal adverse effects are reported and should be monitored. Propranolol should only be given during pregnancy when benefit outweighs risk.
Propranolol has been used safely to treat a variety of conditions during pregnancy, including hypertension and pheochromocytoma in the mother, and tachyarrhythmias in both the mother and fetus. There are a number of abnormalities associated with the use of propranolol during pregnancy, but many of these may be attributable to underlying diseases. These abnormalities include some signs and symptoms of beta-blockade, such as bradycardia, hypoglycemia, and respiratory depression. Other abnormalities that may be due to propranolol include intrauterine growth retardation, small placentas, polycythemia, thrombocytopenia, and hypocalcemia. Structural anomalies associated with propranolol are rare, and have been reported when propranolol was used with a possible teratogen, such as an angiotensin converting enzyme inhibitor, or in the case of significant underlying maternal diseases. In short, propranolol does not appear to be teratogenic, but maternal and fetal propranolol toxicity may occur. For this reason, it is recommended that neonates of mothers who are receiving propranolol be observed for at least 48 hours for signs and symptoms of toxicity, such as bradycardia, hypotension, and hypoglycemia. Data from the Michigan Medicaid Birth Defects study failed to reveal an association between the use of propranolol and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 274 were exposed to propranolol at some time during the first trimester and 470 were exposed to the drug at any time during pregnancy. Eleven total and 3 cardiovascular defects were observed (12 and 3 were expected, respectively). There were two cases of hypospadias. The incidence of birth defects did not achieve statistical significance. These data do not support an association between propranolol and birth defects. The pharmacokinetics of propranolol do not appear to be altered during pregnancy.
Propranolol Breastfeeding Warnings
Propranolol milk to maternal plasma ratios as high as 1.5 are reported. While no adverse effects in the nursing infant are reported, experts advise monitoring the infant for signs and symptoms of beta-blockade and to schedule feedings at least three hours after maternal propranolol administration.
Propranolol is excreted into human milk. Adverse effects in the nursing infant are not reported, and are unlikely. The manufacturer recommends caution be used when administering propranolol to nursing women.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.