FRANKFURT, Jan 30 (Reuters) - Bayer said it was “surprised” by the decision of France’s health regulator ANSM to suspend sales of its acne pill Diane 35, which is also used as a contraceptive.
“We are not aware of any new scientific evidence leading to a change in the positive benefit-risk assessment of Diane-35,” Bayer said in a statement, adding that it would work closely with the ANSM to address the regulator’s questions on the drug.
The ANSM said earlier on Wednesday it was suspending the pill and its generic versions in France, after four deaths over the past 25 years were linked to its use.
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 Jonathan Gould and Frank Siebelt)