Beclomethasone Pregnancy and Breastfeeding Warnings
Beclomethasone Pregnancy Warnings
FDA pregnancy category: C Potential benefit should outweigh the potential risk to the fetus.
Beclomethasone administered subcutaneously (not available in the US) has been shown to be teratogenic and embryocidal in animals when given at approximately one-half the maximum recommended inhalation adult dose. No teratogenicity or embryocidal effects were seen in animals exposed to an inhalation dose of approximately 190 times the maximum recommended daily inhalation dose in adults. There are no reports of adverse pregnancy outcomes in patients receiving beclomethasone during pregnancy. Beclomethasone dipropionate caused decreased conception rates in animals an oral dose approximately 200 times the maximum recommended daily inhalation adult dose. Impairment of fertility was observed in animals following an oral dose approximately 20 times the maximum recommended daily inhalation adult dose. No inhibition of the estrous cycle in animals was seen following 12 months of exposure to beclomethasone dipropionate by the Inhalation route at approximately 15 times the maximum recommended daily inhalation adult dose. 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. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Beclomethasone Breastfeeding Warnings
A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown. Corticosteroids are secreted in human milk. However, considering the low systemic absorption of the inhaled beclomethasone by the mother and rapid metabolism, excretion into milk is unlikely.
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