Yaz and Yasmin Safety and Labeling
Author:Law Office of Rudolph F.X. Migliore, P.C.
On December 8, 2011, Food and Drug Administration panelists voted 21-5 that Bayer’s current labeling on Yaz and Yasmin, (drospirenoen containing drugs,) is “inadequate” and “needs more information” regarding the potential risk of blood clots in the legs and lungs.
The panelists discussed conflicting data for over 9 hours regarding blood clot risk of Yaz, compared to other medications. The overwhelming majority of panelists said that because of the potentially fatal nature of blood clots, the drug risks should be more clearly stated in the label.
“Clearly the wording is inadequate and incomplete,” said Dr. Richard Bockman of 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 New York University School of Medicine stated, “I can see no real group of patients that this drug benefited over the existing alternatives.”
According to the most FDA recent study, women taking Yaz/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.”
It is important for doctors who prescribe Yasmin to discuss the risks of the birth control drug with their patients. Patients who believe they have been harmed by Yaz or Yasmin should consult an experienced products liability attorney (http://www.migliorelaw.com) who can explain their legal rights and determine whether they have grounds for a lawsuit to recover damages.