French Regulators Pull Bayer Acne Drug Over Deaths

Two days after launching an investigation into four deaths linked to the Diane-35 acne medicine sold by Bayer, which is also prescribed as a contraceptive, French authorities have halted the sale of the drug. More than 300,000 women are using the drug for contraception, according to the National Agency for the Safety of Drugs and Health Products. The deaths were attributed to venous thrombosis, a risk that has been noted with the drug and an issue that prompted French authorities to ask the European Medicines Agency to change prescribing guidelines for third- and fourth-generation oral contraceptives after the drugs were found to carry a higher risk of blood clots compared with earlier versions of the medicines (see this). Since 2011, French authorities have been reviewing the risks and benefits of medicines that were approved for use prior to 2005. And they note that, since 1987, 113 other non-fatal cases of venous thrombosis have been reported (see a question-and-answer summary here). The suspension also covers generic versions. “This drug is not licensed for use as a contraceptive,” ANSM director Dominique Maraninchi told a press conference, according to France24. “…But it is being used as such, in this secondary role… yet there are plenty of other alternative contraceptives that can be used in this country.” The move to suspend sales is significant because this signals a tougher stance by authorities in a major Western market toward saf...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Acne Bayer Contraceptives Diane-35 Mediator Servier Source Type: blogs