Inhaled steroids for Asthma appear safe in pregnancy. (Concerns Raised With Oral Steroids).

SAN ANTONIO -- Accumulating data suggest that the use of inhaled corticosteroids to treat asthma does not pose an increased risk to the fetus, Dr. Michael Schatz said at an AstraZeneca-sponsored symposium held at the annual meeting of the American College of Allergy Asthma, and Immunology.

Indeed, physicians who care for asthmatic women of childbearing age should be aware that the budesonide dry powder inhaler has been upgraded to pregnancy category B, Dr. Nancy K. Ostrom said in a poster presentation at the meeting.

Current guidelines from the National Heart, Lung, and Blood Institute recommend inhaled corticosteroids as preferred first-line therapy for patients with mild to severe asthma.

Until recently, however, all of these drugs were rated as pregnancy category C by the Food and Drug Administration because human and animal data were insufficient to rule out teratogenicity. The rating suggested that they only be used during pregnancy if their benefits justified any potential risk to the fetus, said Dr. Ostrom, who is in group practice in San Diego.

In December 2001, the FDA upgraded the labeling of the budesonide dry powder inhaler (Pulmicort Turbohaler) to pregnancy category B, based on Swedish birth registry data from 2,014 infants that showed no increased risk for congenital malformations (Obstet. Gynecol. 93[3]:392-95, 1999).

The budesonide dry powder inhaler is currently the only inhaled corticosteroid with a pregnancy category B rating and the only asthma controller medication for which that rating is based on human data. (The nonsteroidal agents cromolyn, ipratropium, montelukast, nedocromil, and zafirlukast also are category B, based on animal studies showing no fetal risk.)

In a study sponsored by AstraZeneca, maker of the Pulmicort Turbohaler, faxes were sent to ob.gyns. in the United States who had been in practice 2-25 years and were treating at least five women of childbearing age (15-44 years) with asthma in a typical month. Some were randomly selected, while others were selected from a group who wrote high numbers of asthma prescriptions.