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Conflict regarding the Dangers of Yasmin/Yaz

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Washington, DCSince 2003, the FDA has been warning women of blood clots and other serious side effects associated with Yasmin or Yaz, and just recently announced another safety warning, yet the agency stopped short of stating that the birth control pill's risks outweigh the benefits.

The FDA issued a safety announcement (Sept 26, 2011) stating concern "about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills." Yet after completing its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills (Yasmin and Yaz contain the highest amount of drospirenone), it has not reached a conclusion. The agency is still reviewing the "conflicting" studies and is scheduled to release full findings of the agency-funded study this December.

Between 2004 and 2008, Yasmin (also known as Yaz) had reportedly caused more than 50 deaths in women as young as 17. In 2007, the advocacy group Public Citizen called for a ban on Yaz, citing studies from 1995 onwards linking it to heart attack and stroke.

Since that time, thousands of lawsuits have been filed against Bayer, the manufacturer. Bayer has also come under fire from the FDA for misleading the public, saying its marketing is misleading and that it has promised medical benefits such as treatment of PMS and even acne not approved by the agency. Still, Yasmin and Yaz are widely prescribed.

Bayer's $20 million advertising campaign a few years back may have backfired as plaintiffs say it did nothing to warn them about the pill's dangers before they started taking it. Instead, it promoted the benefits of drospierenone as opposed to other progestins.

Bayer's voice-over says in the commercial that "You may have seen some Yaz commercials recently that were not clear…The FDA wants us to correct a few points in those ads." But its corrections were not in synch with the FDA. Instead Bayer said that "Yaz is used to treat the less serious premenstrual dysphoric disorder and moderate acne, not the more serious premenstrual syndrome or mild acne as Bayer once advertised." It also said "Ask about Yasmin, and the difference a little chemistry can make."

Consequently, Bayer was issued a warning letter by the FDA in July 2003 because, among other things, the maker failed to disclose that "YAZ has additional risks because it contains the progestin, drospirenone...which may result in potentially serious heart and health problems."

According to Bayer's 2009 Annual Report (page 243), as of February 15, 2010, there were about 1,100 (including Yaz, Yasmin and Ocella) lawsuits pending in the US. "Plaintiffs seek compensatory and punitive damages, claiming, in particular, that Bayer knew or should have known the alleged risks and should be held liable for having failed to disclose them or adequately warn users of Yasmin® and yaz®..."

According to the Madison St. Clair Record, 53 more lawsuits were filed against Bayer in St. Clair County Circuit Court this past summer. Their claims are similar to those plaintiffs in the Multi-District Litigation in federal court in East St. Louis: Yasmin and Yaz cause gallstones, blood clots and more serious adverse events—including heart attack and stroke.

Bayer's annual report also says that "additional lawsuits are anticipated."


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