Since the late 2000s, more than 12,000 women have filed lawsuits claiming that the birth control drug Yaz, and a similar product, Yasmin, caused blood clots that led to injuries or deaths. Both drugs are manufactured by Bayer.
Yaz was approved in 2006 as a treatment for premenstrual dysphoric disorder, a more severe form of PMS.
A ڴŮ/Journal Sentinel analysis found the drugs were tied to more than 10,800 adverse events reported to the FDA by health professionals and manufacturers since 2013. That included more than 200 deaths and more than 6,000 hospitalizations.
Those problems were all reported years after the market peaked for the drugs in 2008. Further, the analysis focused on reports of problems submitted by health care professionals and drug companies.
As such, the number of complications is likely much higher.
The actual number likely is much higher because the system is voluntary for doctors.
"We take all adverse events seriously," said Bayer spokesperson Jennifer Brendel, who noted the reports to the FDA are not verified to determine if the drug listed actually caused the reaction.
Cayla Hibbard, 29, of Oconomowoc, Wisc., began using Yasmin in 2006 for birth control and also to help control her menstrual symptoms, including bad cramps, according to a 2010 lawsuit she filed against Bayer.
At the time, she was active in sports such as soccer and was going to school to learn how to be a massage therapist.
As she was walking up a flight of stairs one day in 2007, she had trouble breathing. She was taken to a hospital where a CT scan showed she had a pulmonary embolism, a potentially deadly blood clot in the lungs.
Yasmin has never been approved to treat premenstrual syndrome. Yaz only is approved to treat the more severe symptoms that occur in women with PMDD.
However, in 2008 the FDA issued a citing the company for using TV ads that misleadingly indicated that Yaz could be used to treat PMS. The FDA said the ads also misled women into thinking that Yaz would eliminate their symptoms entirely when in reality the drug was not much more effective than a placebo.
In 2009, studies linked such as Yaz and Yasmin that contain the to a higher rate of dangerous blood clots.
Three years later, an by as much as threefold, compared with other hormonal birth control pills. It added that information to the labels of the drugs and told women and their doctors to weigh the risk before prescribing the pills.
Hibbard's lawsuit, which like many of the other lawsuits was settled confidentially, claimed Bayer knew or should have known that Yasmin was being used to treat menstrual symptoms, even though it is not approved for that. The lawsuit also argued the company fraudulently concealed the safety risks of the drug in order to induce doctors to prescribe it.
Hibbard said she needed to use blood thinners for 6 months until the danger posed by the clot passed.
"I am very lucky," she said.
Bayer spokesperson Tara DiFlumeri said the FDA has supported the continued use of Yaz and Yasmin, and their generic versions. She said the company settled the cases to avoid the cost and distraction of lawsuits.
She noted the agreements do not include an admission of wrongdoing and said the company strongly believes the drugs do not increase the risk of either deep vein thrombosis or pulmonary embolism.
"As part of our longstanding commitment to women's health," she wrote in an email, "Bayer believes that it is important that women have access to a wide range of safe and effective birth control options."