EU watchdog backs Bayer acne drug for certain patients

Bayer’s acne pill Diane 35 and its generic versions are safe to use in certain women when other options have failed, the European Medicines Agency said on Friday.

Following a formal safety review, conducted at the request of French authorities, the agency concluded that the benefits outweighed the risks - provided measures were taken to minimize the chance of blood clots forming in veins and arteries.

The medicines should be used solely in the treatment of moderate to severe acne in women of reproductive age and only when alternative treatments, such as topical therapy and oral antibiotic treatment, have failed.

French authorities suspended sales of drugs in January after four deaths over the past 25 years were linked to their use. Bayer said at the time it was “surprised” by the suspension.

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.

(Reporting by Ben Hirschler; editing by Kate Kelland)

###

Reuters