FDA Requires Update to Dangerous Side Effects on Yaz/Yasmin Label

On December 8th, experts at the Food and Drug Administration (FDA) met to determine the future of the birth control pills Yaz and Yasmin. Rather than take the drugs off the market, FDA experts voted to require manufacturer Bayer to change its drug labels and include more warnings about the potential risk of blood clots.

The FDA called the meeting after its study and four others revealed that the risk of blood clots is higher with Yaz and Yasmin than with other birth control pills. Experts who participated in the meeting voted 21 to 5 to update the label, while only 15 experts voted that the pills are a beneficial option for women seeking to prevent pregnancy.

Those who voted against the drug cited that there are other birth control pills on the market that work just as well as Yaz and Yasmin to prevent pregnancy. One expert, Mark Woods of New York University School of Medicine, said “I can see no real group of patients that this drug benefitted over existing alternatives. Without any clear benefit, and given the potentially catastrophic risk, I voted no.”

Despite the vote in favor of a label change, the FDA has not yet set a schedule for when the labels must be changed.

Dangerous Side Effects More Common with Yaz/Yasmin
Bayer, the manufacturer of Yaz and Yasmin, conducted two studies in which the risk of blood clots was found to be no higher with Yaz or Yasmin than with other birth control pills. But the FDA’s study of the drugs concluded that the risk of blood clots in women taking Yaz and Yasmin was 75 percent higher than with other birth control pills.

Several patients who suffered blood clots and their families testified before the panel. One of the family members spoke of how she lost her 20 year-old daughter on Christmas Eve of 2008 when a blood clot traveled to her lung, killing her. Her daughter had been on Yasmin for two months.

Know Your Legal Rights
An estimated 6,000 lawsuits are pending against Bayer throughout the United States, with women claiming that Bayer failed to warn them about the increased risk of blood clots.

If you took Yaz, Yasmin, or another birth control pill that contains Drospirenone, and suffered a blood clot, you may have a claim against the drug’s manufacturer. Call experienced dangerous drug attorney Kay Van Wey today at (214) 329-1350 or (800) 489-5082.