French regulators are on Bayer's trail again. The ANSM agency has launched a probe into four deaths linked to the acne drug Diane-35, also used as a contraceptive. The investigation comes three weeks after ANSM started an inquiry into Méliane, another Bayer contraceptive, and similar third- and fourth-generation birth-control pills.
Both investigations involve worries about blood clots, which are known risks of all hormonal contraceptives. But the newer birth-control pills 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.
As the Telegraph reports, ANSM cited four deaths linked to thrombosis in Diane-35 users over the past 25 years. Three other deaths, reported in the French newspaper Le Figaro, were due to pre-existing health conditions, the agency said. A database of reports from French doctors shows 125 cases of thrombosis related to Diane-35 and related versions of the drug since it was first launched in 1987, the Telegraph says.
Diane-35 is sold as Dianette in some countries. It's only approved in France to treat acne. In all, the drug is available in 116 countries, and about 315,000 French women used it last year, ANSM said. The agency has been particularly sensitive to reports about drug-related side effects since it came under fire for allowing a diabetes drug, Mediator, to stay on the market in France long after other agencies barred it. Mediator has been linked with at least 500 deaths, and the founder of Servier, which made the drug, faces a manslaughter investigation in France.
The FDA and its European counterpart, the European Medicines Agency, have backed the newer contraceptive pills' overall safety. U.S. labeling was updated to include cautionary language about clotting risks. After France announced its probe into newer contraceptives, including Méliane and Bayer's Yasmin line, EU officials said they see no new risks with the drugs.
- read the Telegraph piece