Regulatory Focus™ > News Articles > EMA to Conduct EU-Wide Review of Third-, Fourth-Generation Contraceptives

EMA to Conduct EU-Wide Review of Third-, Fourth-Generation Contraceptives

Posted 28 January 2013 | By Alexander Gaffney, RAC

French regulatory authorities, already reeling from two major scandals involving regulated healthcare products, are now facing yet a third involving an acne and contraceptive drug known as Diane-35.

A report authored by French regulator ANSM and obtained by French newspaper Le Figaro describes serious adverse events suffered by approximately 125 women who took the drug, which is manufactured by Bayer.

The currently unpublished report-set to be released this week-details the deaths from thrombosis of at least four women who took the drug, reports Reuters. An additional three deaths were possibly linked to use of the drug, but less clearly. It remains unclear if those deaths were caused by the drug, or merely associated with it.

Diane-35, generically known as cyproterone acetate, regulates hormones, and is primarily used to treat acne. However, in many countries it is either indicated for use or used off-label as an oral contraceptive-part of the so-called third and fourth generation of contraceptives.

EMA to Conduct Review

In response to the concerns raised in the report, ANSM has reportedly asked the European Medicines Agency (EMA) to review third- and fourth-generation combined oral contraceptives to determine if there is a need to restrict their use to women who are otherwise unable to take other, earlier-generation combined oral contraceptives.

"France has made this request amid recent initiatives to reduce the use of third- and fourth-generation combined oral contraceptives by French women in favor of using second-generation oral contraceptives," EMA wrote in an online post announcing the review.

EMA's announcement noted the already-established risk of patients developing blood clots, but said its Pharmacovigilance Risk Assessment Committee (PRAC) would review the contraceptives to "give its opinion on whether the currently available product information provides the best information possible for patients and doctors to take appropriate healthcare decisions."

Regulators said this is the "first time" that a member state has requested a review and recommendation regarding a medicine under the new pharmacovigilance legislation.

A Series of Scandals

The potential scandal comes in the wake of two other major scandals that occurred between 2011 and 2012 when ANSM's predecessor, Afsapps, was rocked by allegations that it had kept the diabetes drug Mediator on the marketed for years longer than it should have to benefit French drug manufacturer Servier. Then, in 2012, regulators were again rocked by findings that medical device manufacturer Poly Implant Prothese, a breast implant manufacturer, had for years sold a defective implant product made with industrial-rather than medical-grade silicone.

French legislators would eventually reconstitute Afssaps as ANSM in the hopes of giving the regulator a new start and freshened image, as well as new authorities with which to regulate products in postmarket settings.

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