FDA advisory panel recommends stronger warning for drospirenone-containing birth control

February 1, 2012

An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.

An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.

The day-long joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of FDA in December was to involve discussion on the risks and benefits of drospirenone-containing birth control pills because of emerging safety concerns over the potentially higher risk of venous thromboembolism associated with these drugs compared with levonorgestrel-containing drugs, according to FDA meeting materials.

The committee heard testimony on research results from Bayer HealthCare Pharmaceuticals, the manufacturer of a family of drospirenone-containing birth control pills. Research results presented by Bayer demonstrated no increased risk of blood clots, which conflicted with other studies that found evidence that drospirenone was associated with higher risk of blood clot formation.

In September, FDA released a statement informing the public that it remained concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. The agency scheduled the December meeting after several studies demonstrated conflicting results.

"None of the studies to date provides a definitive answer as to the safety of [these contraceptives] with regard to thrombotic and thromboembolic events. The entire body of studies provides conflicting evidence that cannot be easily reconciled by any single difference among studies," according to the FDA materials released prior to the meeting.

Bayer HealthCare thanked the committee members for their efforts and participation in the discussion on the benefit-risk profile for drospirenone-containing combination oral contraceptives.

The company added that it will continue to work with FDA and other regulatory authorities to make label updates as appropriate.