France's drug regulator in January yanked Bayer's contraceptive Diane-35 off the market and insisted the European Medicines Agency investigate its off-label use as an acne treatment and its risk of blood clots. The EMA has done that and has come down in support of the drug, even for the off-label use.
"EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Diane 35 and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms continue to outweigh their risks for the treatment of moderate to severe acne," it reported today. It did suggest the drug only be used when other treatments have failed, and it suggested some labeling changes related to blood clot risks. Its recommendation now goes to a coordinating committee for European states, which will make a final ruling.
France's National Agency for the Safety of Drugs and Health Products (ANSM) in January suspended sales of the drug but gave the 315,000 women who were prescribed the Bayer drug three months to find alternatives. The ANSM took the steps days after launching a probe into four deaths linked to Diane-35. That came three weeks after it started an inquiry into Méliane, another Bayer contraceptive, and similar third- and fourth-generation birth-control pills.
The investigations were looking into concerns about blood clots, which are known risks of all hormonal contraceptives. Current-generation contraceptives, however, contain particular synthetic hormones not used in older versions, and some studies have found a higher risk of serious, sometimes life-threatening, blood clots with those pills. Some of the pills linked to blood clots contain ethinyl estradiol, which is also an active ingredient in Diane-35. The ANSM reported that in the last 25 years, in addition to the four deaths, another 125 women have had blood clots attributed to Diane-35.
France last year remade its drug-regulatory agency after outrage arose about the diabetes drug Mediator, which was being prescribed off-label for weight control. The predecessor agency had allowed the drug, developed by a French company, to remain on the market for years even when it was linked to an estimated 2,000 deaths and thousands of cases of heart-valve damage.
- here's is PRAC's finding (PDF)
- see the EMA release