FDA reviewers are calling for more research on the safety of newer birth-control pills. The agency's expert panelists are gearing up to weigh evidence at a meeting later this week. Canadian regulators say Bayer will revise the labeling on Yaz and Yasmin to reflect an increased risk of blood clots.
And in the middle of all this back-and-forth about Bayer's Yaz and Yasmin contraceptives, some court documents were unsealed, revealing allegations of a Bayer cover-up from ex-FDA Commissioner David Kessler, Bloomberg reports. Expected to testify in upcoming patient lawsuits, Kessler stated Bayer withheld information and analysis suggesting an increase in blood-clotting risk for those taking Yasmin.
"Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin," Kessler said in the document (as quoted by Bloomberg). Kessler also maintained Bayer held back data before Yasmin won agency approval in 2001--including details about clot risks from an internal study, plus two cases of clots in patients using the pill. "Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin's NDA could be made," he stated.
As Bloomberg notes, the court documents were unsealed too late to make the FDA's deadline for materials for this week's advisory committee meeting. The agency wouldn't comment on the documents, the news service reports. Nor would Bayer, whose spokeswoman said the company doesn't comment on outstanding litigation.
- read the Bloomberg story
- get more from The Globe and Mail
- see the Reuters news
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