In December 2001, the US FDA upgraded the pregnancy category rating for budesonide dry-powder inhaler (BUD DPI) to Category B, making it the first ICS with this rating. Two surveys assessed the potential impact of this change on future treatment decisions by allergists and pulmonologists (A/Ps) and obstetricians and gynecologists (Ob/Gyns). (Budesonide inhalation suspension—indicated for use in children 12 months to 8 years of age—was upgraded to Pregnancy Category B in January 2003, making it the second ICS product with this rating.)
Participating physicians who had been practicing for 2-25 years were selected from a marketing database. The first survey included 15 allergists and 60 pulmonologists who spent ≥65% and ≥30% of their practice time, respectively, in an office/outpatient clinic. The second survey included 154 Ob/Gyns who were treating ≥5 asthma patients of childbearing age (15-44 years) per month.
Both A/Ps and Ob/Gyns frequently prescribed ICS for their pregnant patients requiring asthma therapy (68% and 60%, respectively). More A/Ps were aware of a Category B ICS treatment choice (56% of A/Ps versus 30% of Ob/Gyns were aware that an ICS had been upgraded to Category B; 55% of the A/Ps knew that this ICS was BUD DPI, versus 16% of Ob/Gyns.) When informed of this upgrade, A/Ps reported that they would likely prescribe BUD DPI for 61% of their next 20 pregnant patients with asthma appropriate for ICS therapy versus 32% of their previous 20. Ob/Gyns reported that they would likely prescribe BUD DPI for 64% of their next 10 such patients compared with 6% of their previous 10.CONCLUSIONS: Treatment of pregnant women with asthma by A/Ps and Ob/Gyns is consistent with current national asthma treatment guidelines that recommend ICS as a first-line therapy for persistent asthma.
Increased awareness of the availability of a Category B ICS (BUD DPI) will allow appropriate, informed consideration of treatment options for specialists treating pregnant patients with persistent asthma.
N.K. Ostrom, AstraZeneca LP, Grant monies. Professional consultation