(9R)-9-chloro-11-17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10-13-16-trimethyl-6-7-8-11-12-14-15-16-octahydrocyclopenta[a]phenanthren-3-one and Abnormalities--Drug-Induced

Approximately 4% to 12% of pregnant women have asthma; few studies have examined the effects of maternal asthma medication use on birth defects. We examined whether maternal asthma medication use during early pregnancy increased the risk of selected birth defects.. National Birth Defects Prevention Study data for 2853 infants with 1 or more selected birth defects (diaphragmatic hernia, esophageal atresia, small intestinal atresia, anorectal atresia, neural tube defects, omphalocele, or limb deficiencies) and 6726 unaffected control infants delivered from October 1997 through December 2005 were analyzed. Mothers of cases and controls provided telephone interviews of medication use and additional potential risk factors. Exposure was defined as maternal periconceptional (1 month prior through the third month of pregnancy) asthma medication use (bronchodilator or anti-inflammatory). Associations between maternal periconceptional asthma medication use and individual major birth defects were estimated by using adjusted odds ratios (aOR) and 95% confidence intervals (95%CI).. No statistically significant associations were observed for maternal periconceptional asthma medication use and most defects studied; however, positive associations were observed between maternal asthma medication use and isolated esophageal atresia (bronchodilator use: aOR = 2.39, 95%CI = 1.23, 4.66), isolated anorectal atresia (anti-inflammatory use: aOR = 2.12, 95%CI = 1.09, 4.12), and omphalocele (bronchodilator and anti-inflammatory use: aOR = 4.13, 95%CI = 1.43, 11.95).. Positive associations were observed for anorectal atresia, esophageal atresia, and omphalocele and maternal periconceptional asthma medication use, but not for other defects studied. It is possible that observed associations may be chance findings or may be a result of maternal asthma severity and related hypoxia rather than medication use.

Topics: Abnormalities, Drug-Induced; Adult; Albuterol; Anal Canal; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Anus, Imperforate; Asthma; Beclomethasone; Bronchodilator Agents; Case-Control Studies; Esophagus; Female; Fluticasone; Heart Defects, Congenital; Humans; Kidney; Limb Deformities, Congenital; Male; Middle Aged; Pregnancy; Pregnancy Complications; Pregnancy Trimester, First; Radius; Risk Factors; Spine; Trachea; United States; Young Adult

The safety of using inhaled beclomethasone dipropionate for the treatment of severe asthma during pregnancy was evaluated during 45 pregnancies in 40 women. Despite chronic administration of theophylline and, in some women, ephedrine, the asthma was so severe that corticosteroids were essential to prevent emergency room visits and status asthmaticus. At conception, beclomethasone dipropionate was being used regularly during 38 pregnancies and was initiated during the first trimester in 4 other pregnancies. The range of beclomethasone dipropionate inhalations was 4 to 16/d with a mean of 9.5/d (336 micrograms). Prednisone administration was necessary during 37 pregnancies. Status asthmaticus occurred in five women but no mothers or fetuses died. Cardiac malformations occurred in an infant born to a woman who was diabetic and schizophrenic whose pregnancy was complicated by diabetic ketoacidosis and status asthmaticus. It is not known whether beclomethasone dipropionate was the cause of these malformations. The prevalence of congenital malformations (1 of 43 live births) is within the normal range and shows that treatment with beclomethasone dipropionate is safe during pregnancy when recommended doses are used.

Topics: Abnormalities, Drug-Induced; Adult; Aerosols; Asthma; Beclomethasone; Drug Therapy, Combination; Female; Humans; Middle Aged; Pregnancy; Pregnancy Complications; Prospective Studies; Retrospective Studies