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Yasmin Side Effects Lead to Change of European Warning Labels

March 29, 2010

Yasmin Side Effects Lead to Change of European Warning Labels

As more lawsuits are being filed in North America, pharmaceutical giant Bayer Schering announced it will update its European warning labels for its popular birth control medication Yasmin (drospirinone and ethinylestradiol). An updated label for the European Summary of Product Characteristics is expected in the near future.

Bayer states that Yasmin is still considered safe despite some studies having proven a connection between the drug and venous thromboembolism (a potentially lethal clotting in the veins). Although this rare risk is added, it will not change Yasmin’s overall benefit/risk profile, according to the Pharmaceutical Business Review.

The changes were sparked by four independent studies that showed a high incidence in women taking Yasmin and the development of venous thromboembolism. The revised labels will state that taking Yasmin may be the equivalent of taking the emergency oral contraceptive levonorgesterel, thought to occasionally cause venous thromboembolism. Levonorgesterel is also known as brand name Plan B (made by Duramed Pharmaceuticals).

The studies were done at the request of both American and European health officials. Bayer sponsored two of these studies, according to Dow Jones Newswires, but the verdicts still were not in the company’s favor. The results of two older studies are also to be included at the request of the Committee for Medicinal Products for Human Use (CHMP.) In total, more than 120,000 women taking Yasmin were studied.

Venous thromboembolism is considered to be a very rare side effect in women, caused by either evonorgesterel or drospirinone and ethinylestradiol. In women that did develop it, 1 to 2 percent died, according to the British Medical Journal (13 August, 2009.)

Other complaints against Bayer from America and Canada include charges that Yasmin increased blood potassium, caused heart arrhythmia, liver disease, kidney disease and gallbladder failure. Lawsuits contend that Bayer did not sufficiently test drospirinone, a synthetic hormone, before releasing Yasmin to the general public. However, it is unknown whether Bayer’s decision to revise its European label will have any effect on the North American lawsuits.

Yasmin has also been marketed under the brand name Yaz. A generic form is made by Teva Pharmecusticals.

If you or a loved one has experienced a serious side effect or symptoms of side effects related to Yaz, Yasmin or related birth control medications, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication recalls. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.

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