FDA Advisory Panel to Take Up Yaz, Yasmin

The U.S. Food and Drug Administration (FDA) recently sought assistance in its review of Bayer’s Yaz and Yasmin birth control pill line of medications. The advisory panel is scheduled to convene this December to determine if <"http://www.yourlawyer.com/topics/overview/Yaz-Yasmin-Ocella-Lawsuit-Side-Effects-injury-clots-embolism-dvt">Yaz, Yasmin, and other similar medications increase blood clot risks, versus other birth control pills, said FiercePharma.

The panel will review information on the Yaz and Yasmin brands and the generic equivalents of these medications, all of which contain the controversial, synthetic progestin, drospirenone, noted FiercePharma, and which have been linked, in some studies, to increased blood clot risks. As we’ve reported peviously, drospirenone is also found in birth control pills sold under the brands Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi, and Loryna.

Pending the panel’s review, the FDA has warned women taking drospirenone birth control pills, such as Yaz and Yasmin, to be aware of the medications’ possible risks, said FiercePharma.

U.S. health regulators have long been concerned about the blood clot potential from drospirenone-containing birth control pills, such as Yaz and Yasmin. As a matter-of-fact, a recent drug safety communication the FDA posted on its Web site indicated that initial agency-funded study results suggest women who take Yaz, Yasmin and other drospirenone oral contraceptives could face a 1.5-fold increase in the risk of blood clots versus women taking other oral contraceptives.

Although hormonal contraceptives are known to increase risks for venous thromboembolism (VTE), the early FDA data of 800,000 women points to more significant risks, added FiercePharma. Prior studies published in the British Medical Journal (BMJ) revealed risks that are double-to-triple over the typically expected risks for clotting, according to HealthDay; other studies found no change in risk.

The FDA stated that it completed its review of the BMJ research and is analyzing its own research. “… [g]iven the conflicting nature of the findings,” said the FDA, it scheduled a joint meeting of two advisory committees, explained FiercePharma. One committee focuses on reproductive health; the other is concerned with drug safety.

Bayer, not unexpectedly, said its analysis of current data indicates that the clotting risks seen in its line of Yaz and Yasmin oral contraceptives are “comparable” to risks seen in other oral birth control medications, according to the Wall Street Journal. Despite its assertions that Yaz and Yasmin are as safe as other similar drugs on the market, Bayer is looking at thousands of lawsuits alleging just the opposite and that also accuse the drug maker of having run ad campaigns that never disclosed those risks, said FiercePharma.

Because both Yaz and Yasmin are made with drospirenone, they are different from many other oral contraceptives. Drospirenone can elevate potassium levels, which can lead to hyperkalemia in certain patients. Hyperkalemia can result in potentially serious heart and health problems.

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