Tuesday, July 30, 2013
EU Commission clears way for Bayer acne pill sales in France
BRUSSELS |
(Reuters) - The European Commission confirmed on Tuesday that the Bayer acne pill Diane 35 was safe for use, a seal of approval which will oblige France to allow sales of the product.
France is the only European Union country where sales of the treatment were suspended earlier this year after four deaths over the past 25 years were linked to its use.
"The product is entitled to be sold on the market in France," Frederic Vincent, the Commission's spokesman for health affairs, said commenting on the EU executive's decision to approve the drug.
The Commission's seal of approval follows a formal safety review by the European Medicines Agency in May which concluded that the benefits of the pill outweighed any risks provided measures were taken to minimize the chance of blood clots forming in veins and arteries.
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 Claire Davenport; Editing by David Evans)
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