The European Medicines Agency (EMA) has announced that it has started a safety review of Diane 35 (cyproterone acetage 2mg, ethinylestradiol 35µg), a hormone-regulating drug commonly indicated for birth control or acne, in response to French regulators' concerns that patients are at an unacceptably high risk of developing venous and arterial thromboembolism (VTE/ATE).
The drug, as well as its generics, came to the attention of regulators in recent months after French regulator ANSM received reports that as many as four women had died after taking the drug, all having suffered from blood clots. Those risks, inherent in many third- and fourth-generation contraceptives, have long been known to regulators. In France, for example, the drug has been prescribed for more than 20 years.
But Diane 35 and its generics suffer from one regulatory lapse in oversight: They have never been centrally evaluated.
"These medicines have been authorised at the level of individual Member States for many years," EMA explained. "They are widely used across Europe. However, their authorised uses differ between Member States."
In some countries, they are indicated for contraceptive use; in others just for hormone-related contraceptive use. In France, Diane 35 is indicated only for the treatment of acne, though regulators have told EMA the drug is widely used off-label as well.
So now, after French officials conducted a months-long investigation into the product culminating in them asking EMA to conduct an EU-wide investigation, the relatively new Pharmacovigilance Risk Assessment Committee (PRAC) has agreed to investigate the products.
That investigation is set to wrap up in May 2013, when PRAC said it is likely to adopt a recommendation.
This is the first time the PRAC had been asked to conduct a review by a member state under the new pharmacovigilance legislation, EMA said in previous statement.
EMA said patients currently taking the drug should not stop taking it without first consulting with their respective physicians.