FDA eyes stronger warning on birth control

WASHINGTON -- Federal health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed birth control pills such as Yaz in light of evidence that the newer contraceptive drugs may be riskier than older drugs.

In documents released yesterday, the Food and Drug Administration said there is conflicting evidence on the risk, but that the information should appear in labeling used by doctors and patients. "We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility," state the briefing documents from FDA scientists.

On Thursday, the FDA will ask a panel of outside experts to weigh in on the issue and to consider whether some women should not take the drugs. The FDA is not required to follow the panel's advice, though it often does.

Yaz and several other pills contain a man-made hormone called drospirenone, which was heavily marketed as carrying fewer side effects than earlier drugs.

In the past two years several large independent studies have suggested the blood clot rate with drospirenone-containing drugs is slightly higher than with other hormone-based contraceptives.

Studies conducted by German drugmaker Bayer, which markets Yaz and the related pill Yasmin, found no increased risk of blood clots.

But looking across the half-dozen studies available, FDA scientists say the risk of blood clots appears most likely in the first 3 to 6 months taking a drug, and increases among older women. -- AP