Bayer AG, the German drug maker responsible for the Yaz and Yasmin line of birth-control pills, will have to pay “at least $110 million to settle about 500 lawsuits,” Bloomberg News reported recently. According to the article, Bayer officials agreed to pay out an average of around $220,000 per case for allegations that Yasmin and Yaz caused blood clots in users, sometimes leading to fatal stroke and heart attack.
Blood clots that develop in larger, deeper veins are known as deep vein thrombosis (DVT) and can lead to serious and life-threatening complications. Use of these medications also presents a risk of pulmonary embolism, which occurs when blood clots travel to the lungs and block one or more of the arteries there.
Bloomberg notes this case was just the first of about 11,000 lawsuits Bayer faces regarding alleged injuries caused by these drugs. On April 10, the U.S. Food and Drug Administration released an updated warning for the risk of blood clot associated with drospirenone-containing birth control medications, which includes Yaz and Yasmin.
According to some studies, drugs containing this synthetic hormone present as much as a threefold risk increase of blood clot compared to products with other hormones. The FDA notes that label changes on these drugs will notify users of the risks.
However, critics of the medication remain doubtful whether these simple label changes will actually help protect consumers. Furthermore, this is not the first time Bayer has been forced to update written information on this line of birth control products.
In 2009, the company came under fire for ads that regulators said overstated Yaz’s other health benefits in users, including acne relief and mood improvement. The FDA and attorneys general of 27 states then forced the company to run new ads which corrected those misleading marketing claims.
The company agreed to spend a minimum of $20 million on clarifying advertisements, as well as submit all new Yaz ads for federal screening for the next six years. At that time, Yaz was the best-selling oral contraceptive in the U.S., holding about 18 percent of the market.
Yasmin was first approved by the FDA in 2001 and Yaz followed five years later. While very similar, 24 of the 28 Yaz tablets in each packet contain drospirenone, compared to just 21 of Yasmin’s 28 pills.
Today, Bloomberg explains that Bayer’s Yasmin is the fourth most popular oral contraceptive in the U.S., holding about 4.6 percent of the market as of last September. This is despite the growing number of lawsuits Bayer has faced since 2009. From 2004 to 2008, Bloomberg reports at least 50 deaths have been linked to this line of the drug maker’s medications.