France’s National Security Agency for Medicines and Health Products (“ANSM”) announced today that swift action has been taken to halt the sale of the hormonal acne drug, Diane-35. Linked to the deaths of four women recently, the drug manufactured by Bayer was also being prescribed as a birth control pill in Europe. Women in France will need to find a new birth control/acne medication within the next three months.
French investigators have also requested that the European Medicines Agency (an agency similar to the FDA that harmonizes all medicine agencies in the European Union, including France) change prescription guidelines for so-called third and fourth generation oral contraceptives after these drugs were found to carry a higher risk of blood clots as compared to earlier versions.
In addition to today’s action, France’s ANSM initiated an investigation into Méliane, another of the newer generation contraceptives manufactured by Bayer. Meliane has also been linked to life threatening blood clots.
France has indicated that the investigations will not end with Diane-35 and Meliane. Bayer’s Yasmin line (Yaz, Yasmin and Ocella) are also newer generation contraceptives that have been linked to blood clots and are likely to be added to the French investigation. In the United States, there have been just short of 23,000 adverse health reports where Yaz was found to be the primary suspect.
We will continue to watch where the EMA takes this investigation. In the United States, Bayer finds themselves deeply entrenched in litigation with regards to Yaz, Yasmin and Ocella. Just last November, Bayer announced $750 million settlement to 3,490 claimants and those settlement will continue to grow as more women come forward to report their injuries.
So with serious injuries continuing to mount, evidence of overstated success already demonstrated, and overseas investigations ongoing, one can only hope that manufacturers like Bayer work to fix the damages they have already caused.