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FDA Looking into Yaz, Yasmin Blood Clot Risk

Jun 1, 2011 | Parker Waichman LLP

Yaz, Yasmin and other birth control pills that contain a synthetic progestin called drospirenone are the subject of a new U.S. Food & Drug Administration (FDA) safety review because of their possible connection to blood clots.  In addition to Yaz and Yasmin, the FDA safety review will encompass generic forms of both drugs (Yaz: Gianvi, Loryna; Yasmin: Ocella, Syeda, and Zarah), as well as birth control pills sold under the brand names Beyaz and Safyral.

Yaz, Yasmin and other drospirenone contraceptives have already been named in more than 6,000 U.S. lawsuits, many of which claim the drugs caused users to suffer blood clots.  Many of those lawsuits have been consolidated in a multidistrict litigation in federal court in the Southern District in Illinois (MDL No. 2100).  A partner in the firm of Parker Waichman LLP is a member of the Plaintiffs' Steering Committee in that litigation.

The FDA announced it was reviewing the safety of all drospirenone contraceptives in a Drug Safety Communication released yesterday afternoon.   The review was prompted by two studies that recently appeared in The British Medical Journal which reported a two- to three-fold greater risk of venous thromboembolic events (VTEs) – including life threatening deep vein thrombosis and pulmonary embolism  – in women using oral contraceptives containing drospirenone rather than levonorgestrel (another form of progestin).

All birth control pills carry a risk of blood clots.  According to the FDA, four earlier studies had been inconclusive as to whether the risk of blood clots was higher with drospirenone.  Two, which were commissioned by the FDA or European regulators, found no higher risk.  However, two others published in 2009 did indicate that the risk of blood clots was higher in women using drospirenone-containing products than in women who use levonorgestrel-containing products, according to the FDA.  The results from all four studies are already summarized in the label for drospirenone contraceptives.

The FDA is still evaluating data from a large study of 800,000 women that examined blood clot risks with  all forms of oral contraceptives.   Those results should be available this summer, the agency said.

In yesterday's Drug Safety Communication, the FDA said it would continue to evaluate the safety of Yaz, Yasmin and other contraceptives made with drospirenone.  However, the agency is allowing these drugs to stay on the market. The FDA is advising that patients and physicians should be able to recognize symptoms of deep vein thrombosis and VTE, and they should discuss the risks that may be associated with drospirenone.

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