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FDA Panel Says Yasmin Labeling "Inadequate"

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Washington, DCThe concern over Yasmin birth control continues to mount, after an expert panel of the US Food and Drug Administration (FDA) voted overwhelmingly December 8 that labeling information for the hugely popular form of birth control is woefully inadequate. While the panel agreed—in a closer vote—that Yasmin should remain on the market, concern abounds nonetheless.

In Canada, that country's national health agency announced prior to the FDA panel meeting that Yasmin, in Health Canada's view, carried a higher risk of blood clots than risks associated with older contraceptives. There have been lawsuits initiated in both countries with the help of a Yasmin lawyer.

Bayer continues to stand behind its product, as do some doctors. And the evidence continues to lurk in the periphery of reasonable doubt. Indeed, according to a CBS News report on December 10, there was much disagreement amongst the expert panelists concerning the quality of evidence suggesting an increased risk for Yasmin blood clots.

Still, in a vote 21-5, the panel members decreed that current product labeling is inadequate.

"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. He added that adverse events have to be articulated in a more graphic way, allowing physicians and patients the chance to become aware of the potential for Yasmin side effects.

Yasmin is among the latest generation of birth control pills, employing the use of a synthetic hormone known as drospirenone. Amidst a marketing campaign that touted (inappropriately, as it was later determined) Yasmin's capacity for fostering clearer skin and reduced water retention, women turned to Yasmin and its sister contraceptive Yaz in droves—rapidly propelling it to become the most popular oral contraceptive in the US.

That popularity has dipped, however, since safety concerns over Yasmin and Yaz side effects have surfaced. CBS News noted that prescriptions have fallen more than 80 percent in the last two years.

Most in the medical profession agree that there is a slight risk for blood clots associated with all contraceptives. Bayer, the manufacturer of Yasmin birth control, has always maintained that products containing drospirenone carry no greater risk for blood clots than any of the others. Two studies undertaken by Bayer, in fact, support that conclusion.

But other studies into the Yasmin pill have experienced different outcomes. CBS reported that five large studies determined a slightly higher risk for blood clots associated with the use of drospirenone when compared against other birth control pills. Those studies noted events are rare. And a recent FDA study found that the absolute risk of blood clot is far less than a fraction of one percent.

In the same breath, however, the FDA study found that women taking Yasmin were 75 percent more likely to suffer a blood clot, then patients taking older-generation contraceptives.

Mark Woods, a panel member who voted against leaving Yasmin on the market, noted in a CBS interview "I can see no real group of patients that this drug benefitted over existing alternatives."

Woods, of the New York University School of Medicine, continued, "without any clear benefit, and given the potentially catastrophic risk, I voted no."

That vote was 15-11 in favor of allowing Yasmin birth control to remain on the market. The panelist voted more decisively to recommend beefed-up labeling.

"I think we can do a much better job than labels I have seen," said Dr. Valerie Montgomery Rice, of the Morehouse School of Medicine, in comments published by CBS on December 10.

Previous research suggests 10 in 10,000 women taking the newer birth control pills will experience a blood clot, compared with 20 out of 10,000 women who are now pregnant or have just given birth.

Health Canada announced earlier this month that Yasmin carries a risk factor for blood clot of 1.5, to three times higher for women on Yasmin and Yaz v. those on older contraceptives.

Many women have become incapacitated, allegedly from taking Yasmin or Yaz. Some women have died from blood clots, including women in their twenties. Many a Yasmin lawsuit has resulted.


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