France Launches Bayer Drug Safety Probe After Deaths Linked to Diane-35

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By: Irvin Jackson | Published: January 30th, 2013

French officials are investigating the potental side effects of a Bayer acne and birth control drug, known as Diane-35, following reports of at least four deaths. 

The investigation is the most recent problem for Bayer’s birth control products, several of which have come under scrutiny in recent years for an increased risk of blood and other serious health problems.

While Diane-35 (cyproterone acetate) is marketed as an acne drug in France, it is sold under the name Dianette as a contraceptive in Canada and some European countries. It has not been approved for sale in the U.S.

The French National Drugs Safety Agency (ANSM) has said that four deaths due to blood clots have been linked to Diane-35 in that country. Another three deaths among users of the drug were identified, but those cases involved other health issues that make the connection less clear. The agency expects to release a report of its findings next week.

The investigation was announced less than a month after ANSM also began calling for limitations on the use of new contraceptives, such as Bayer’s controversial Yaz and Yasmin birth control pills. At the beginning of the year ANSM launched an inquiry into how so-called third and fourth-generation birth control pills are being prescribed, and said that the country will no longer reimburse prescription costs of third-generation pills, like Bayer’s Meliane, after March 31.

Concerns center around recent findings that newer birth control pills may double the risk of blood clots when compared to older birth control pills. As a result, users may face an increased risk of health problems like deep vein thrombosis, pulmonary embolism, and stroke.

The findings come as Bayer continues to face thousands of Yaz lawsuits and Yasmin lawsuits filed in the United States. The complaints allege that the drug maker failed to adequately research the risk of potential side effects from Yaz and Yasmin before aggressively promoting the products as superior to older birth control pills.

An increasing number of women are also pursuing claims against Bayer over health problems from the Mirena intrauterine device (IUD), an implantable form of birth control that has been linked to problems where it may migrate from the intended position, perforate the uterine wall or cause other complications. The Mirena IUD lawsuits also allege that Bayer failed to adequately research the potential risks associated with the birth control and improperly marketed the birth control while providing misleading information about the potential side effects.

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