I’ve been closely following the ongoing litigation and safety reviews surrounding Yaz and Yasmin—and, as a pharmaceutical liability attorney, I help clients who believe they’ve been injured by those drugs. So I was very interested to see a report from the Canadian Press that Health Canada, the Canadian national health agency, believes it can attribute at least 23 women’s deaths to the use of Yaz or Yasmin. The numbers come from a review of adverse reaction reports submitted to Health Canada. A total of 600 adverse reactions were reported for the two drugs, and among those were 23 deaths, largely sudden deaths attributed to blood clots. The information will fuel the ongoing lawsuits against the drugs’ manufacturer, Bayer, which, in the U.S., allege that Bayer failed to adequately warn patients of the increased blood clot risk compared to older contraceptives.
Blood clots are a known risk of oral contraceptives, which mimic female hormones that also cause a higher risk of blood clots during pregnancy and childbirth. Yaz and Yasmin use a newer type of oral contraceptive called drospirenone, which was first sold in the U.S. in 2001 as Yasmin; Yaz followed in 2006. Bayer’s own studies found no increased risk of blood clots from using the drospirenone-containing drugs, but independent studies later found a substantially increased risk. In October of 2011, an FDA warning said women taking drospirenone-containing pills were 74 percent more likely to suffer blood clots than women on other hormonal contraceptives. In federal court documents, a former FDA commissioner alleged that Bayer withheld evidence of the increased risk in Yasmin safety reviews provided to the agency. Bayer is now facing thousands of lawsuits in the United States alone.
The company also faces lawsuits in Canada, including a class-action suit with plaintiffs including Stephanie Kerr of Ontario. Kerr was an acive 16-year-old when she started taking Yasmin. About a month later, she nearly collapsed from shortness of breath while she was out on a run. A hospital scan showed her lungs were full of blood clots. She took blood thinners for six months, missed school, had to give up dancing and even said she had trouble walking long distances for a while. She is one of hundreds of Ontario women claiming injuries in the class-action case; their law firm also represents families of 13 patients who died. The Health Canada data shows that more than half of the patients who died after taking drospirenone were under the age of 26; one was a fourteen-year-old girl.
As a dangerous drug lawyer, I’m pleased to see that the Canadian authorities are keeping track of this. Here in the United States, the FDA has estimated at least 50 deaths from Yasmin and Yaz between 2004 and 2008. But all the same, the FDA took no action during previous safety reviews, and the drugs remain on the market—though since 2007, they’ve carried a “black box” warning, the FDA’s strongest, of the blood clot risk. Blood clots are a medical emergency because they are life-threatening when they travel to the lungs, causing a condition called pulmonary embolism. With that much at stake, I believe Bayer would be negligent if it truly failed to warn patients about a risk it knew they ran from taking its new, highly profitable drugs. As a defective drug attorney, I help patients sue drug companies for this kind of potentially dangerous failure.
If you believe you were hurt by a medication you thought would help, you should call Carey, Danis & Lowe today to discuss your legal options. You can reach us toll-free at 1-877-678-3400 or send us a message online.
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