Washington, DCWith reports of more than 50 deaths in the approximately four years from 2004 to 2008, little wonder the US Food and Drug Administration (FDA) has ordered the manufacturer of Yasmin and Yaz, together with the makers of other third-generation oral contraceptives containing the synthetic hormone drospirenone, to strengthen warnings with regard to blood clots, or deep-vein thrombosis. Yasmin blood clots, and similar concerns over Yaz, have been at the forefront of countless lawsuits.
It's been about four months since the FDA mandated those warnings. And yet, many of the deaths and grievous health issues that have befallen countless woman date back prior to the FDA mandating labeling changes in an effort to further illuminate Yasmin side effects.
For manufacturer Bayer, the German-based pharmaceutical giant, it appears to be business as usual.
Bloomberg News (7/31/12) reported at the end of July Bayer had set aside more than $600 million in reserve to fund the expected settlements, court costs and legal fees associated with lawsuits concerning its drospirenone-based contraceptives. And this is over and above any proceeds from insurance coverage. Bayer, according to Bloomberg, has said that in excess of $402 million has already been paid out to settle one category of Yaz side effects and Yasmin blood clot cases. Industry analysts have said the German drug maker may have to pay out over $2 billion to settle all outstanding and expected claims.
And yet neither Bayer, nor the FDA appear to be in any hurry to do anything beyond increase the clarion call of warnings, and to fund a defense against a growing parade of lawsuits. Bayer, to any outcry surrounding adverse reactions associated with Yasmin or Yaz birth control, consistently answers with staunch support of its products, noting that all oral contraceptives carry a risk for blood clot.
That's essentially true. However, various studies have suggested that Yasmin, Yaz and other birth control pills containing drospirenone carry a higher risk for blood clots. That risk, according to Bloomberg, is quantified to reflect a tripled threat for Yasmin DVT over that of older, more conventional birth control pills.
Nonetheless, Bayer said in an emailed statement to Bloomberg News, "We believe we have made appropriate provisions for most of the cases we consider to be worthy of settlement with these accounting measures." The statement related to funds already paid, and funds held in reserve for future costs associated with Yaz lawsuits (and those associated with Yasmin), beyond funds available through insurance, an amount Bayer would not specify.
Yasmin birth control, and its close cousin Yaz have, in under a decade, risen to become one of the top choices for birth control in America. Early marketing efforts, which Bayer had to eventually rescind, promised less bloating and clearer skin with use of Yasmin and Yaz.
Yaz birth control pills, as well as Yasmin, are the third best-selling drug in Bayer's global portfolio, according to data compiled by Bloomberg. Bayer appears to be acknowledging Yaz lawsuits while keeping their product on the market. The tripled threat of blood clots potentially associated with Yasmin and Yaz has yet to deter the FDA, either.
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