FDA approves first extended-cycle OC: available this month: may cause higher incidence of spotting.(News)

The Food and Drug Administration has approved Seasonale, a 91-day oral contraceptive designed to reduce a woman's menstrual periods to four per year.

Although women may like the convenience of having fewer periods, they should be prepared for a higher incidence of breakthrough bleeding than is usually seen with standard 28-day oral contraceptives, said Dr. Pablo Rodriguez, associate chief of ob.gyn. at Women and Infants Hospital of Rhode Island in Providence.

In a trial comparing Seasonale with a dosage-equivalent 28-day regimen, 7.7% of women on Seasonale stopped taking the pills prematurely, compared with 1.8% of those on the 28-day regimen.

Dr. Rodriguez doesn't anticipate that breakthrough bleeding will deter women from using Seasonale if they are fully informed about this possibility. He cites women's ongoing willingness to use Depo-Provera and Norplant, both of which can cause breakthrough bleeding.

"It's a matter of counseling [patients] appropriately and letting them know that breakthrough bleeding has nothing to do with efficacy. Women get upset and sometimes scared when they see breakthrough bleeding, not because it's happening, but because they feel that the contraceptive may not be working," he said.

Women who use Seasonale will take pills containing active hormones for 84 days (12 weeks) followed by placebo pills for 7 days. The active ingredients--levonorgestrel and ethinyl estradiol--are used in other OCs.

The manufacturer, Barr ...