France to Suspend Sale of Diane 35


January 30, 2013

The French National Agency for Medicines and Health Products Safety (ANSM) announced today that it plans to suspend sales of an acne treatment used off-label as an oral contraceptive that is linked to at least 4 deaths from venous thromboembolism (VTE) over the last 25 years.

The acne drug in question is cyproterone acetate 2 mg, ethinylestradiol 35 mg (Diane 35, Bayer, and its generics). Diane 35 is approved in France only for treating acne, but several other countries in the European Union (EU) have approved it for treating acne in women who also want to use it as an oral contraceptive, according to the European Medicines Agency (EMA), which functions as a food and drug regulatory agency for the entire EU. In addition, clinicians widely prescribe Diane 35 as a contraceptive on an off-label basis.

The US Food and Drug Administration (FDA) has not approved the drug for use in the United States.

Today's announcement by the French equivalent of the FDA followed a review of Diane 35 that concluded that the drug and its generic versions increase the risk for VTE. At the same time, Diane 35 is only moderately effective at treating acne, and clinicians can turn to alternative treatments, ANSM stated.

The ANSM said it would suspend sales of Diane 35 and its generic versions 3 months from now. In the meantime, it said, clinicians should no longer prescribe the medication. Patients should not abruptly stop taking Diane 35, but instead should talk to their clinician about the treatment options best for them.

Bayer released a statement today saying that it was surprised by the ANSM decision. It said there is no new scientific evidence that would warrant a change in the risk-benefit assessment of Diane 35.

The decision to suspend sales of Diane 35 resembles another action that European regulators have taken in response to the VTE risk of oral contraceptives. On January 28, the EMA announced that, at the request of the ANSM, it will review whether the EU should restrict the use of third- and fourth-generation combined oral contraceptives to women who cannot take earlier versions. There is a higher risk for VTE with the latter generations of these contraceptives, according to the EMA.

The EMA today said in a press release that France intends to request a similar European-wide review of Diane 35 and its generic versions. Once that request is received, the EMA's Pharmacovigilance Risk Assessment Committee will study the risks and benefits of these drugs and recommend on how they should be marketed, if at all.