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Bayer Adds New Label Warnings to Yasmin, Yaz

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Washington, DCBayer, the manufacturer of Yasmin and Yaz birth control, decided earlier this month to beef up product labeling with warnings about blood clots. Sales of the contraceptives will continue in the US and Europe, under the condition that the black box warning is updated there as well.

On 4/4/10 Forbes printed an Associated Press (AP) report on the results of two large multi-year studies of more than 120,000 women using contraceptives in the US and the UK. Based on the findings of those two studies, the US Food and Drug Administration (FDA) approached Bayer about adding new labeling with regard to the risks of blood clots with Yaz and Yasmin—risks also associated with other oral contraceptives.

The 4/13/10 issue of the Virginia HS Injury Law Blog points out that Bayer previously stated that warning labels for Yaz and Yasmin clearly outlined the risks. However, the most recent revisions to the product labeling urged by the FDA "debunks that defense," the blog says.

Judy Jones is a concerned mother whose daughter is allegedly suffering from various side effects associated with Yaz: "My daughter has been taking this pill for about 4 years and is having kidney problems and has not had her period for 5 months she also says that her bowel movements are not normal after hearing about this pill on the news and reading on line I'm concerned..."

Yaz and Yasmin are two of the newer group of contraceptives that contain a combination of drospirenone and ethinyl estradiol, both derivatives of naturally occurring female hormones.

The Yasmin / Yaz pair were identified as the top-selling drugs for Bayer last year, with combined sales of $1.64 billion worldwide. However, Bayer has also been faced with scores of lawsuits from plaintiffs who allege Yaz or Yasmin triggered serious health issues, including blood clots.

Bayer continues to stand behind its product.


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