Should the FDA Recall Yaz and Yasmin?

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Ennis & Ennis, P.A. Raises Questions about Yaz and Yasmin Ahead of the FDA Meeting

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Will the FDA protect Bayer’s profits or women’s safety?

The Food and Drug Administration’s (FDA) primary responsibility is to ensure that all medications it evaluates and approves are safe for public use. The pharmaceutical companies presumably extensively research and test new medications and provide this data to the FDA’s Center for Drug Evaluation Research (CDER). Unfortunately, the CDER conducts no research or testing, rather it simply relies on the data provided to it by the drug company. Ennis & Ennis, P.A. questions this process. What if the manufacturer presents incomplete information? Or excludes possible side affects because the company deems it “statistically unlikely”? These oversights, coupled with the pressure from drug manufacturers to accelerate the approval process, make the FDA especially vulnerable to premature approval of new products. Further compounding this problem is that a large portion of the FDA’s funding comes directly from the drug companies themselves, which creates an astounding conflict of interest.

A classic example of the FDA’s failure as our government watchdog is the current litigation over the birth control pills Yaz/Yasmin/Ocella (hereinafter Yaz), which have been proven to increase the risks of strokes, deep vein thrombosis (DVT), pulmonary embolisms, and gallbladder disease. These lawsuits allege that this drug has gravely or fatally injured thousands of women. Furthermore, according to the former FDA commissioner, Bayer’s unit researchers found increased reports of blood clots in users of its Yasmin birth-control pills and the company withheld the information from U.S. regulators, which was reported by Bloomberg News. David Kessler, the former FDA commissioner, in a document unsealed today in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin safety provided to the agency. The data revealed “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said.

Attorney Holly Ennis of Ennis & Ennis, P.A. asks, "Could this have been prevented if the FDA was not rushed and pressured to approve new medications by Bayer and other companies? Shouldn’t the FDA require stringent post-marketing studies of these products? And, more importantly, what is the FDA doing about Yaz?"

Bayer’s Yasmin was first approved for use in the United States in 2001. Then in 2006 Bayer’s Yaz was approved as an oral contraceptive and as a medication to treat premenstrual dysphonic disorder (PMDD), which is the most severe form of premenstrual syndrome (PMS). However Bayer aggressively marketed Yaz as a seemingly “miracle drug” that treated all types of PMS symptoms, such as irritability, moodiness, bloating and anxiety, while also eliminating increased appetite and acne. As a result, in 2008 the FDA ordered Bayer to pull their television ads wherein Bayer overstated the pill’s effectiveness and minimized the serious risks associated with it. Bayer went on to spend $20 million on corrective spots. Interestingly though, according to TNS Media Intelligence, Bayer spent more than $270 million on TV and magazine advertising between 2007 and 2010. In effect, Yaz was the best-selling birth control pill in the U.S. for 2008 and 2009 and was Bayer’s second best selling product last year generating nearly $1.6 billion in sales.

More importantly, Yaz products contain drospirenone, a synthetic hormone, which is linked to a six-fold increase in the risk of venous thromboembolism, a formation of clots in the lower leg that can become loose and travel to the lungs. This risk is compared with a three-fold risk in women using older contraceptives containing levonorgestrel. Further, there is no evidence that Yaz is superior to older, safer birth control pills.

From 2009 - 2011, there have been over seven published studies finding drospirenone significantly increases the risk of blood clots in women. In fact, it has been found that levonorgestrel, a hormone used in older, first generation birth control pills, had the lowest risk of blood clots, had the same effectiveness in pregnancy prevention and was the safest option. Ennis inquires, "If the efficacy of Yaz is the same as the “older, safer pills” and studies raised the question of Yaz safety in the summer of 2009, why has it taken the FDA this long to convene? Over these last two and half years, how many woman have taken Yaz or Yasmin and suffered these devastating side effects?"

Clearly the FDA is aware of the dangers of these third and fourth generation birth control pills. The FDA not only has reviewed findings from several epidemiologic studies evaluating the risk of blood clots containing drospirenone but has also conducted its own studies. These studies also showed a significant increase in the risks of blood clots and other injuries from drospirenone-containing birth control pills and the FDA “remains concerned” about these increased risks. As such the FDA has scheduled a joint meeting with two advisory committees on December 8, 2011 to discuss these risks.

Given the information widely known regarding Yaz, clearly the FDA is aware that Yaz is nearly twice as likely as other oral contraceptives to cause blood clots and other health consequences and has not been shown to be at all superior or provide other major benefits. That begs the following questions: Why is Yaz still on the market? Why hasn’t the FDA put a black-box warning on the label? Should the FDA recall Yaz and Yasmin? The real question is: Will the FDA protect Bayer’s profits or women’s safety?

Holly Ennis is a Florida attorney who concentrates her practice in representing clients nationwide again pharmaceutical companies and medical device companies. She has represented clients who have suffered adverse side effects from Yaz, Yasmin, Vioxx, Fosamax, Avandia, and Zyprexa, as well as clients who have been affected by the Depuy Hip Implant recall. Holly Ennis can be reached at hckennis(at)ennislaw(dot)com or 1-800-856-6405. To learn more about Holly, visit


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