FDA States Yaz Birth Control Needs More Risk Information

Thursday, December 8, 2011 FDA Panelists Vote on Safety and Labeling of Yaz/Yasmin

Data suggests higher risk of blood clots in patients using Bayer’s Yaz and Yasmin when compared to older contraceptive pills according to Federal Health Experts.

The expert panel of the Food and Drug Administration voted 21-5 that Bayer’s current labeling on Yaz and Yasmin (drospirenone containing drugs) is “inadequate” and “needs more information” regarding the potential risk of blood clots in the legs and lungs.

Panelists discussed conflicting data for over 9 hours regarding blood clot risks of Yaz compared to other medications. The overwhelming majority of panelists said that because of the potentially fatal nature of blood clots, the drugs’ risks should be more clearly stated in the label.

“Clearly the wording is inadequate and incomplete,” said Dr. Richard Bockman of the New York Hospital for Special Surgery. He continued, “adverse events have to be made graphic, so physicians and patients are aware of the consequences.”

Mark Woods of the New York University School of Medicine states, “I can see no real group of patients that this drug benefited over the existing alternatives.”

According to the most recent study by the FDA, women taking Yaz and Yasmin had a 75 percent higher risk of suffering a blood clot when compared with patients taking a combination of older drugs. Although the absolute risk of a blood clot is still relatively low, even a slightly higher risk can be critical or fatal if the blood clot triggers a heart attack, stroke or blockage to the lungs or blood vessels.

Earlier in the day, panelists heard from patients and family members who blame Yaz and Yasmin for sometimes deadly blood clots. Cindy Ripee spoke of her last conversation with her 20 year old daughter Elizabeth. “My daughter was a very smart young woman. If Elizabeth had been clearly told that Yasmin had more risk, maybe twice as much risk as other pills, she never would have switched to Yasmin and would be here today.”

The Food and Drug administration has not set a timetable for any changes in Yaz’s labeling.