France Concerned About Yaz Side Effects

Paris, FranceAuthorities in France are reportedly concerned enough about the risk of Yaz side effects that they will ask the European Union to restrict the use of certain birth control pills. Newer generation birth control pills, including Yasmin, Yaz and Ocella, have been linked to an increased risk of deep vein thrombosis and other health problems. Although the US Food and Drug Administration (FDA) has issued warnings about Yasmin side effects and the risks associated with Yaz birth control pills, the contraceptives have not been pulled from the market.

According to Reuters (1/11/13), officials in France are not asking the EU to recall the pills, but will ask that the prescription guidelines be changed, to recommend that only women who cannot use other contraceptives be given the newer birth control pills. The newer birth control pills have been linked to an increased risk of blood clot, although the European Medicines Agency has said women should continue using the contraceptives.

One study that confirmed the link between drospirenone-containing birth control and venous thrombosis was published in CMAJ (Canadian Medical Association Journal; 11/7/11). Researchers analyzed the records of 330,000 women in Israel. What they found was a significantly increased risk of deep vein thrombosis and pulmonary embolism in women who used birth control that contained drospirenone. According to researchers, the risk with drospirenone-containing birth control was between 43 and 65 percent higher than with older birth control pills.

Overall, the risk is still low, at about eight to 10 blood clots per 10,000 women who use the birth control each year. But it is higher than the six blood clots per 10,000 women who use other birth control pills each year.

Researchers also noted that the risk of a thromboembolism decreases within three months of a woman discontinuing her birth control and that the risk of a thromboembolic event was highest in the first months of using the birth control.

Venous thromboembolisms generally form in the patient’s legs, but if they come loose they can travel to the lungs, causing a potentially fatal pulmonary embolism. Lawsuits have been filed against Bayer HealthCare Pharmaceuticals, Inc, the maker of various drospirenone-containing birth control pills, alleging patients were not adequately warned about the risks associated with the pills.