Acne Drug Pulled After Women Die
The National Agency for the Safety of Drugs and Health Products (ANSM) in France this week suspended sales of an acne drug linked to the deaths of several women.
The drug, Diane-35, is a hormonal acne treatment, but was begin prescribed as contraceptives to hundreds of thousands of women in France. The medication was found to have played a role in at least four deaths. Blood clots in other women have also been linked to the medication.
The suspension will roll out over the course of months, allowing women enough time to find alternate contraceptive methods.
The director of the ANSM, Dominique Maraninchi, told the AFP that the drug is not licensed for use as a contraceptive. He emphasized that there are many other contraceptives available to French women.
The AFP report states that the ANSM has requested a change in prescription guidelines for third and fourth generation oral contraceptives (such as Diane-35), which have higher blood clot risks.
This suspension is similar to one ANSM issued in November 2009. At that time, at drug marketed as “Mediator” (benfluorex) was pulled from pharmacy shelves after it was linked to hundreds of deaths in France. The drug was approved for the treatment of diabetes, but was often prescribed as an appetite suppressant for overweight patients.