PARIS — France's health regulator ANSM said on Wednesday it would suspend sales of Bayer acne pill Diane 35 and its generic versions, all also used as a contraceptive, after four deaths over the past 25 years were linked to its use.
About 315,000 women used Diane 35 or its generic version in France last year. Bayer officials were not immediately available to comment on the suspension of the drug, which is sold in over 100 countries, typically under brand names including Dianette.
The four deaths linked to Diane 35 were due to blood clots, and three other deaths possibly connected to the drug were also linked to other health issues, the agency said.
ANSM said it would phase the suspension over three months to allow women to switch to other treatments.
Diane 35 reduces acne by regulating hormones and blocking ovulation, and is often prescribed as a contraceptive even though it is not approved for this use.
Doctors will not be able to prescribe Diane 35 or its generic versions to new patients from Wednesday.
ANSM said this month it was studying the possibility of limiting the use of third- and fourth-generation contraceptive pills, also made by Bayer, after a woman sued the German drugmaker over alleged side-effects including blood clots.
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