French regulators are tightening the purse strings on later-generation contraceptives--and studying limits on their use. Acting on concerns that the pills carry a higher risk of blood clots than older birth-control brands, the country's health ministry will stop paying for third-generation pills beginning March 31.
Meanwhile, as Reuters reports, France's ANSM health regulator launched a probe this week, saying that doctors may be over-prescribing third- and fourth-generation birth-control pills. French officials said the newer pills should only be prescribed by specialists. Now, midwives and nurses can also prescribe the pills.
The French moves follow the FDA's long-term review of some lower-dose contraceptives. After new studies suggested a higher risk of serious blood clots with birth-control pills containing drospirenone, the agency in 2011 asked an advisory committee to weigh the data. The committee backed the pills in a 15-11 vote but suggested a labeling update. Then, in April, the FDA added data on the pills' clotting risks to their official labels. Bayer maintains that its own research hasn't turned up any additional risk with its newer pills when compared with older contraceptives.
The courts are conducting their own review, with thousands of U.S. lawsuits over the Bayer pills Yaz and Yasmin. The German drugmaker set aside $500 million last year to settle a big chunk of that litigation, and then earmarked another 200 million euros ($262.2 million) during the third quarter. And now that litigation extends to France as well; a woman sued Bayer in mid-December, saying her stroke was caused by the contraceptive Méliane, a third-generation pill that contains gestodene, a form of progestin.