Regulatory Focus™ > News Articles > Safety Concerns Assuaged, Birth Control Pill Back on the Market in France

Safety Concerns Assuaged, Birth Control Pill Back on the Market in France

Posted 14 January 2014 | By

An acne drug also commonly used for birth control indications is slated to return to the market in France more than a year after French regulators first warned that the drug could be dangerous, prompting an EU-wide review of the drug and changes to its approved indications.


The drug, known as Diane 35 (cyproterone acetage 2mg, ethinylestradiol 35µg), had been associated with an elevated risk of developing venous and arterial thromboembolisms (VTE/ATE), more commonly known as blood clots.

Though the association between contraceptives and thromboembolisms has long been known, French regulators (ANSM) were concerned that the risk inherent in Diane 35 was overly pronounced, and called upon the European Medicines Agency (EMA) to review the medicine through its central evaluation procedure.

The drug, regulators noted, had never undergone full EU review as it had been marketed before EMA even existed.

Responding to the French regulator's concerns, EMA initiated an investigation through its Pharmacovigilance Risk Assessment Committee (PRAC), marking the first time the committee-which was then relatively new-had been asked by a member state to review an already-marketed medication.

In May 2013, the PRAC returned its assessment of the drug, calling it generally safe on balance but in need of some precautions to minimize the risk of blood clots to patients.

"Since Diane 35 and its generics act as hormonal contraceptives, women should not take these medicines in combination with other hormonal contraceptives," EMA wrote. "Concomitant use of Diane 35 and its generics with another hormonal contraceptive will expose women to a higher dose of oestrogen and increase the risk of thromboembolism."

Back on the Market

But even as PRAC cleared the drug of the most serious regulatory concerns, French regulators-who have experienced several major scandals since 2012-have been slow to allow the drug to return to the market.

But according to a statement on the website of ANSM, the drugs will, as of mid-January 2014, be allowed to return to the French market with certain restrictions. For example, the drugs will now be reserved for second-line treatment of moderate to severe acne for patients with hyperandrogenism.

ANSM also said that a risk management plan (RMP) will be established by each manufacturer in order to "minimize risks and in particular to study the use of these drugs."

ANSM Statement on Diane 35

Tags: France, EU

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