Controversy continues to swirl around Yaz and Yasmin, Bayer Healthcare’s popular birth control pills. While Bayer touts two studies it commissioned as proof that the drugs are safe, 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.
One study, which looked at blood clot risks in healthy Danish women ages 15 to 49, found that of 4,213 cases of various kinds of blood clots reported between 1995 and 2005, more than 2,000 occurred in women who used oral contraceptives. Contraceptive pills made with the synthetic progestins desogestrel, gestodone and drospirenone all had a higher risk of blood clots compared to those made with an older form of progestin called levonorgestrel.
The second study, which involved 3,200 women in the Netherland, found those taking pills with levonorgestrel had a four times higher risk of getting blood clots than women taking no birth control. However, the other types of pills carried a higher risk. Those made with drospirenone were 6.3 times more likely to be associated with blood clots. Only pills made with desogestrel had a higher risk – 7.3 times greater.
Dr. Sidney Wolfe, founder and director of Public Citizen’s Health Research Group, told The Los Angeles Times that the studies’ conclusions are reason for concern. He said the second study “clearly concludes that the safest thing to do is take the older [birth control pills], not the third generation or Yaz.” Wolfe also added that his group has already put Yasmin on its “Do Not Use” list because it can raise blood potassium levels.
Bayer, of course, insists that Yaz and Yasmin are safe. According to the Los Angeles Times, the company cites two studies that concluded that there was no greater risk of mortality, cancer or cardiovascular problems from pills with drospirenone than other oral contraceptives. But both of those studies were paid for by the drug maker.
The controversy surrounding Yaz and Yasmin has attracted scrutiny. According to The Times, the U.S. Food & Drug Administration (FDA) is conducting an ongoing study of pills like Yaz and Yasmin to evaluate their safety. As of November, the agency had 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.
In the U.S., Yaz and Yasmin have been named in about 1,100 lawsuit, many of which are consolidated in a multidistrict litigation in federal court in the Southern District in Illinois. Bayer also faces three putative consumer class actions claiming economic loss, one of them also claiming personal injuries, as well as two class actions in Canada. The lawsuits claim Yaz and Yasmin caused plaintiffs to suffer blood clots, heart attacks, stroke, gallbladder disease and other side effects of Yaz.