Yaz Pulmonary Embolism Death Leads to Investigation by Swiss Regulators

A probe has been launched by Swissmedic, the medical regulatory agency in Switzerland, over the death of a young woman who suffered a pulmonary embolism that appears to have been caused by side effects of Yaz birth control. The investigation comes as the drug’s maker, Bayer Pharmaceuticals, faces a growing number of Yaz lawsuits and Yasmin lawsuits in the United States over similar injuries.

According to Swissmedic, a Yaz pulmonary embolism potentially resulted in the mid-September death of a woman who had been taking the birth control pill for 10 months. The Swiss investigators are looking into a possible link between the woman’s death and Yaz, which has been associated with an increased risk of blood clots when compared with some other birth control pills.

Yaz is a reformulated version the Yasmin birth control pill, and both medications are manufactured by Bayer. They are combined oral contraceptives containing ethinyl estradiol and drosperinone, which is a new type of progestin that is not used in any other birth control pill. The use of drosperinone can cause an increase in potassium levels, potentially leading to a condition known as hyperkalemia, which can cause heart problems and potentially be fatal.

Over 50 reports of Yasmin or Yaz deaths were received by the FDA between the first quarter of 2004 and the third quarter of 2008, according to some of the complaints filed in the United States. The deaths involved women as young as 17 and included cardiac arrests, pulmonary embolisms and strokes, with elevated levels of potassium in the blood frequently reported.

This is the second time Swissmedic has investigated Yaz side effects, as the regulatory agency first began investigating Yaz and all birth control pills after the May 2009 death of a 16-year-old girl, who suffered a lung embolism while taking Yaz. The agency reports that there have been nine deaths in Switzerland that may be due to birth control pill side effects since 1990.

In response to the Swiss investigation, Bayer officials have maintained that they do not believe Yaz has any higher risk of pulmonary embolism than other contraceptive.

Last week, the United States Judicial Panel on Multidistrict Litigation heard arguments from attorneys on whether to consolidate the litigation over Yaz and Yasmin birth control pills. There are currently at least 74 lawsuits filed against the company where users allege that they suffered a heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism, gallbladder disease or sudden death from Yaz or Yasmin.

The complaints allege that the drug maker failed to adequately research their birth control products, fraudulently concealed the risk of injury, negligently failed to warn about the degree of risk women faced and misrepresented the safety of Yasmin and Yaz in comparison to other available birth control pills.