Swiss media reports that nearly 200 women have died while taking Bayerâ€™s blockbuster contraceptives <"http://www.yourlawyer.com/topics/overview/YAZ">Yaz and Yasmin. According to BNET, 190 women have died and Bayerâ€™s shareholders are furious with how Bayer marketed the drugs.
A shareholder motion is expected at the annual meeting on April 29; however, said BNET, the motion will likely not pass. Regardless, shareholders are hoping that the move will bring attention to Bayerâ€™s contraceptive medication debacle.
As of February 2011, lawsuits against Bayer topped 6,850 in the United States with claims that the pills led to potentially lethal blood clots and gall bladder damage, said BNET, citing page 242 of Bayerâ€™s annual report. Lawsuits are expected to continue to rise based on prior figures in which 4,200 lawsuits had been filed as of October 2010 and 2,000 as of September, said BNET.
While the number of deaths cited in the lawsuits is not known, a German-language report on Swiss Television claimed that a U.S. Food and Drug Administration (FDA) adverse event database search discovered 140 fatalities linked to Yasmin and 50 to Yaz, said BNET, which said that the search described the numbers â€œin round figures.â€ The disturbing figures will be brought up at this monthâ€™s shareholder meeting.
Meanwhile, said BNET, because the database includes unconfirmed reports, the actual number of deaths linked to Yaz and Yasmin might be lower; however, release of those numbers and the number of lawsuits filed will create challenges for the drug maker, especially when it attempts to defend its estrogen-progestin combination as being safer than older medications.
We recently wrote that Bayer has been touting two studies it commissioned as proof that the drugs are safe, while other studies have found that contraceptives like Yaz and Yasmin increase the risk of blood clots more than other types of birth control pills.
Yasmin, first marketed in 2001, and Yaz, introduced in 2006, are made with a synthetic progestin called drospirenone. It was once thought that this ingredient was safer than other forms of progestin. But, according to a report in The Los Angeles Times, two 2009 studies published in The British Medical Journal have called this theory into question.
Dr. Sidney Wolfe, founder and director of Public Citizenâ€™s Health Research Group, told The Los Angeles Times that the studiesâ€™ findings are reason for concern. One study, Dr. Wolfe said, â€œclearly concludes that the safest thing to do is take the older [birth control pills], not the third generation or Yaz.â€ Wolfe also added that his group has already put Yasmin on its â€œDo Not Useâ€ list because it can raise blood potassium levels.
Bayer continues to insist that Yaz and Yasmin are safe and, according to the Los Angeles Times, cites two studies that found there was no greater risk of mortality, cancer, or cardiovascular problems from pills with drospirenone than other oral contraceptives. Those studies were paid for by Bayer.
The controversy continues prompting the FDA to conduct an ongoing study of pills like Yaz and Yasmin to evaluate their safety. As of November, the agency received reports of 993 cases of pulmonary embolism (blood clots in the lungs), 487 of deep vein thrombosis (clots in the deep veins), and 229 of other blood clots for the two medications combined, The Times said.