Bloomberg is reporting, in “BAYER WITHELD YASMIN DATA FROM U.S., FORMER FDA HEAD SAYS” that former FDA Commissioner, David Kessler, in his capacity as an expert witness in litigation against the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, has stated that “Bayer presented a selective view of the data, and the presentation obscured the potential risks associated with YASMIN“. Presently, all FDA approved DRSP (DROSPIRENONE) containing contraceptives contain 3mg of DRSP (DROSPIRENONE). In referring to the company’s ‘new drug application’, he is quoted as stating: “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“. Additional details in the story call into question when the now confirmed higher risk of blood clots was in fact known to BAYER, or the prior manufacturer, BERLEX, which was acquired by BAYER.
The nondisclosure of risk information to potential users, and physicians, arguably demonstrates a failure to properly, or adequately inform the public of risks associated with DRSP (DROSPIRENONE) containing birth control pills. How can anyone undertake a risk, or consent to accept them, if they are not disclosed or communicated. Kessler is further quoted as stating that “Bayer had a duty to present a full and balanced view of all the data and analysis concerning YASMIN to the FDA and health care professionals and failed to do so“. The impact of Kessler’s anticipated testimony on pending FDA hearings remains to be determined. FDA hearings are scheduled for 12.8.11 to consider the findings of FDA funded study that confirmed a higher risk was associated with DRSP (DROSPIRENONE) birth control and echoed findings of prior studies that have repeatedly reached the same conclusion. The manufacturer continues to dispute this data and refers back to studies it used to gain FDA approval for the pills.
Within hours of the story above being reported, HEALTH CANADA announced that it had concluded a ‘safety review’ of DRSP (DROSPIRENONE) containing birth control pills. HEALTH CANADA concluded, through a review of recent observational studies, that current evidence suggests the risk of a blood clots, from DRSP (DROSPIRENONE) containing birth control, is 1.5x-3.0x higher than with those containing different hormones (i.e.> levonorgestrel). Additional information was reported by CBCNEWS, in “YASMIN, YAZ Birth Control Pills May Increase Clot Risks“.
Granted, the statistical risk of having a blood clot is reported as 1 in 10,000 women that fails to consider the fact that the DRSP (DROSPIRENONE) family of birth control pills have been on the market for over a decade and current labeling is still ‘evolving’ to represent this risk in warning labels. Meanwhile, the manufacturer continues to dispute the risks and findings of studies. Notably, even FDA funded study arrived at the conclusion that the pills were 1.74x higher risk, or 74% higher risk, and thus presented a significantly higher risk than other FDA approved birth control pills. The failure to warn, when information was available and how, if at all it was disclosed, or buried as suggested by Kessler above, is at the heart of over 10,500 DRSP lawsuits. Not all of these cases are blood clot cases, however it appears that without civil litigation there would not be full disclosure of risks or the impetus to sponsor science to reach conclusions other than those advanced by the manufacturer.
What will the FDA do following 12.8.11?
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