Tuesday, December 13, 2011

Yaz Litigation Likely to Heat Up After FDA Relabeling

Last week the FDA voted 21-5 to revise the labeling on Yaz, Yasmin, Beyaz, Safyral, and its generic versions to clarify the potential risk of blood clots in the legs and lungs from taking the pills.  After debating the conflicting data for more than nine hours, the panelists disagreed on the evidence's quality but agreed that the risks should be clearly stated in the label.  Here's an excerpt from the Huffington Post's report:

"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

In an earlier vote, panelists voted 15-11 that the pills remain a beneficial option for preventing pregnancy. The majority ruling amounts to a vote of confidence for keeping the drugs on the market, though well over a third of panelists voted against the drug's overall benefit, citing numerous alternatives available.

"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."

Two large studies conducted by German drugmaker Bayer have shown no difference in blood clots between patients taking the company's drugs and patients taking older medications.

But since 2009, five large studies have suggested drospirenone-containing pills carry a slightly higher risk of blood clots than older birth control pills, though events in both groups are very rare. Even a slightly higher risk can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels.

Here's a link to a TIME magazine report and to a recent NY Times piece.

ECB

 

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