New Yaz, Yasmin Warnings May Understate Blood Clots Risk
The law firm of Hissey Kientz, LLP is concerned that soon to be released warnings about the risk of blood clots from the birth control pills Yaz and Yasmin may not go far enough to warn users about the potential health risks of these products.
The manufacturer of the two drugs, Bayer Pharmaceuticals, recently announced plans to add a new warning about the risk of blood clots from Yaz and Yasmin to drug labels in Europe and the United States. “While we welcome the decision to add new information about the link between Yasmin or Yaz and blood clots, we are concerned that these warnings will not go far enough to alert women of the true dangers of these drugs,” says attorney Kristin Giaquinta Schoen of Hissey Kientz.
In a press release announcing its plans to update the labels of Yaz and Yasmin, Bayer stated that the risk of blood clots for women taking these pills was “comparable” to that of other birth control pills. But according to two studies published by the British Medical Journal in July 2009, women who use Yaz and Yasmin are twice as likely to suffer blood clots as they are when taking other forms of birth control containing the synthetic hormone levonorgestrel. This increased blood clot risk can lead to other serious and potentially deadly conditions, including heart attack, stroke, pulmonary embolism and deep vein thrombosis.
“Bayer’s claim that the risk of blood clots with Yaz and Yasmin is ‘comparable’ to other birth control pills is contradicted by the research of scientists who have investigated these drugs,” Schoen says. “Studies have shown that women taking Yaz and Yasmin are more likely to experience blood clots and other side effects than women taking other birth control pills.”
Yasmin and Yaz were approved by the FDA in 2001 and 2006, respectively. Since then, the FDA has received more than 50 reports of deaths among users of these products and hundreds of reports of blood clots or other injuries from Yaz and Yasmin.
In 2009, the FDA sent a warning letter to Bayer after the company aired a television ad campaign promoting Yaz. The agency said that the campaign understated the risk of side effects associated with Yaz while improperly promoting it to treat acne and PMS symptoms, two conditions which it was not approved to treat. As a result of these advertisements, the FDA forced Bayer to run a $20 million ad campaign to correct the “misleading” claims about Yaz and to warn users of the health risks they may face from taking it.
Approximately 1,100 lawsuits have been filed by women who were injured after using Yaz or Yasmin. Although hundreds of women have been injured after using the two drugs, both remain top-sellers for Bayer, with over $1.64 billion in combined sales during 2009. The company has not announced any plans to recall Yaz or Yasmin.