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FDA Wants Blood Clots Added to YAZ Labels

The U.S. Food & Drug Administration (FDA) has recommended that the labels for birth control pills Yaz and Yasmin, manufactured by Bayer HealthCare Pharmaceuticals, be strengthened to include more information about the increased risk of blood clots.

This is not Bayer’s first appearance at the FDA scrutiny rodeo. In 2008, Yaz was the best-selling birth control pill in the United States, pushed by an advertising campaign said to have cost hundreds of millions of dollars. You might remember these original ads:  A group of beautiful, young women in a cool restaurant or club are talking with their friend, who happens to be a doctor. She informs her friends that Yaz is birth control, but also prevents severe premenstrual symptoms and clears up acne. As the saying goes, if it sounds too good to be true, it probably is.  The FDA cracked down, and in 2009, Bayer was required to run a $20 million advertising campaign designed to correct its previously deceptive—and some might say irresponsible—commercial ads. Bayer’s new ads warned that nobody should take Yaz hoping that it would also prevent PMS or pimples.

This new problem is more serious.

According to an article in The New York Times, there has been a question of whether Yaz, which contains a synthetic form of progestin called drospirenone, is more likely to cause blood clots than other, more conventional contraceptive pills. In October 2011, the British Journal of Medicine published research showing that women taking Yaz or Yasmin had double the risk of blood clots, compared with women taking older contraceptives.

Currently more than 10,000 lawsuits have been filed on behalf of women who were harmed by Yaz or Yasmin…including about 100 fatalities. According to The New York Times:

In documents released recently in those lawsuits, David Kessler, a former F.D.A. commissioner working as an expert witness for the plaintiffs, said that Bayer researchers found increased reports of blood clots in women using Yasmin in the United States, compared with those using three other pills, but did not provide that information to the F.D.A. in a 2004 safety review.

“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Dr. Kessler testified. He also said the company promoted the pill for alleviating premenstrual syndrome, when it was not approved for that use.

To many experts and non-experts alike, blood clots are too great a risk. And many young women may not understand what “blood clots” really means. It sounds innocuous and minor, but the results can be devastating. If the clot lodges in the heart, it can cause a heart attack…if it lodges in the brain, it can cause a life-changing stroke. According to an article in the New York Daily News:

“I can see no real group of patients that this drug benefited over existing alternatives,” said Mark Woods of New York University School of Medicine. “Without any clear benefit, and given the potentially catastrophic risk, I voted no [to keeping the drug on the market].”

If you are a woman who has been injured after taking Yaz or Yasmin birth control pills and have questions about your rights, feel free to call the experienced attorneys of HensonFuerst. Someone is available to take your call 24 hours a day, 7 days a week at 1-800-4-LAWMED. If you have questions, HensonFuerst has answers.

RESOURCES

To read the article in The New York Times about the 2009 advertising correction, click here: A Birth Control Pill That Promised Too Much

To read the article in The New York Times about the blood clot risk, click here: More Detail on Risk Urged for a Contraceptive Label

To read the article in the New York Daily News, click here: Yaz and other birth control pills to get harsher labels

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