|The ANSM is suspending sales of Diane-35.--Courtesy of Bayer|
France's drug regulators last year faced scathing criticism for dragging their feet when it came to the dangers of off-label use of diabetes drug Mediator. Now faced with consumer fears over deaths tied to off-label use of Bayer acne drug, Diane-35, they are acting with dispatch.
The National Agency for the Safety of Drugs and Health Products (ANSM) is suspending sales of the drug but giving users three months to find alternatives, The Telegraph reports. The agency said the drug is prescribed to 315,000 women in France. The ANSM took the steps days after launching a probe into four deaths linked to Diane-35, also used as a contraceptive. And that came three weeks after it started an inquiry into Méliane, another Bayer contraceptive, and similar third- and fourth-generation birth-control pills. It also has asked the European Medicines Agency to do a review of the contraceptives.
The investigations are looking over 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 ethinylestradiol, 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. ANSM Director Dominique Maraninchi, in a press conference, said the a benefit-risk review of the drug as an acne treatment had also not been favorable, leading the agency to pull the product.
In a statement to The Telegraph Bayer said the risks are known and spelled out in its labeling. It said the drug shouldn't be prescribed for anything but its intended use.
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. There also was an outcry when the public learned that a French company had been making breast implants using industrial-grade silicone, which were rupturing and causing medical issues.
- read The Telegraph story