Pregnancy Warnings

Beclomethasone Pregnancy and Breast Feeding Warnings

Beclomethasone is also known as: Beclovent, Qvar, Vanceril, Vanceril DS

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Beclomethasone Aerosol Solution while you are pregnant. It is not known if Beclomethasone Aerosol Solution is found in breast milk. If you are or will be breast-feeding while you use Beclomethasone Aerosol Solution, check with your doctor. Discuss any possible risks to your baby.

Beclomethasone Pregnancy Warnings

Beclomethasone has been assigned to pregnancy category C by the FDA. Beclomethasone administered subcutaneously (not available in the US) has been shown to be teratogenic in animals when given at doses 10 times the doses administered to humans. Teratogenic effects in animals were not seen when beclomethasone was administered at high doses by inhalation or orally. There are no reports of adverse pregnancy outcomes in patients receiving beclomethasone during pregnancy. There are no controlled data in human pregnancy. Beclomethasone is only recommended for use during pregnancy when benefit outweighs risk.

Successful pregnancy has been reported in patients receiving beclomethasone by inhalation to control asthma. Review of 56 pregnancies in 51 women who received either beclomethasone or oral prednisone found a lower birth weight and higher incidence of premature births but no other adverse effects. Birth weight was lowest in patients experiencing status asthmaticus during pregnancy. In another review of 45 pregnancies in 40 women, beclomethasone use again was not associated with adverse pregnancy outcomes. One patient, whose pregnancy was complicated by schizophrenia, diabetes mellitus and status asthmaticus, gave birth to an infant with numerous cardiac malformations. In a review of 229,101 deliveries to Michigan Medicaid patients, 395 first-trimester exposures to beclomethasone were recorded and 970 exposures any time during pregnancy. A total of 16 birth defects were reported with first trimester exposure (16 expected). (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) This data does not support an association with adverse fetal outcome.

Beclomethasone Lactation Warnings

There are no data on the excretion of beclomethasone into human milk. However, considering the low systemic absorption of the drug by the mother and rapid metabolism, excretion into milk is unlikely.

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