Yaz was pitched as the blockbuster birth control pill with benefits, the choice for women desperate for relief from severe PMS and acne. But now, several new independent studies have found that Yaz carries higher blood clotting risks than other leading birth control pills, leading to new scrutiny from safety regulators.
Former FDA Commissioner Dr. David A. Kessler, who is now working for lawyers suing Bayer, which makes Yaz, accusing the drugmaker of concealing the contraceptive’s health risks.
“Bayer violated its duties under FDA regulations and state law by selectively presenting data as to [blood clotting] events,” Kessler said in court documents, citing studies that Bayer itself conducted but allegedly misreported to regulators.
He indicated that if he had been head of the FDA in 2000 and knew what he knows now, he may not have approved the drug.
“In my opinion, had I, or a medical review officer, known these facts prior to approval, further investigation would be…