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Study: Yaz Has Higher Risks of Blood Clots ... - Prescriptions Blog

A new study of 1.3 million Danish women over nine years adds to the evidence that some newer birth-control pills, including the best-seller Yaz, have a higher risk of causing potentially dangerous blood clots.

Newer pills containing drospirenone, a synthetic hormone, were linked to a six-fold increase in the risk of venous thromboembolism, which is the formation of clots in the lower leg or thigh that can break loose and travel to the lungs.

That risk was compared with a three-fold increase in women using older contraceptives containing the synthetic hormone levonorgestrel. The study was published Tuesday on the Web site of BMJ, formerly known as the British Medical Journal.

A BMJ editorial added, “It is crucial, however, not to exaggerate the risk — oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality.”

The Food and Drug Administration is already studying the possible increased risk of blood clots with pills containing the drospirenone. The F.D.A. says its preliminary results suggest a 1.5-fold increased risk compared with other hormonal contraceptives, to about 10 women in 10,000 from 6 women in 10,000.

Studies have differed, though. Some found no increased risk among women taking the newer pills. The F.D.A. has scheduled a joint meeting of two advisory committees on Dec. 8 to review the risks and benefits.

Bayer, the German drug company that makes Yaz and the related product Yasmin, has said the two have similar clot risks to other combination birth control pills, including levonorgestrel. The company updated its labels last year with that indication.

The new study, sought by the European Medicines Agency, challenges that finding.

Bayer, in a brief statement Wednesday, said it is “currently evaluating this publication and cannot comment at this time.”

Bayer also said its clinical data from more than 15 years supports the company’s assessment that its hormonal birth control products are safe and effective when used as indicated and that the risk of venous thromboembolism is similar to that from taking any other low-dose estrogen product studied.

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