The European Medicines Agency‘s Pharmacovigilance Risk Assessment Committee (PRAC) has formally started a safety review of acne drug Diane 35 and its generics, after the French announced plans to suspend marketing authorisations for the drug.
The French medicines regulatory agency (ANSM) requested a Europe-wide review of the drug after concerns of a heightened risk of venous and arterial thromboembolism – blood clots in the veins and arteries – associated with the drug over a 20 year period.
Diane 35 is authorised as a contraceptive in women in some member states with hormone-related conditions such as acne, hirsutism and alopecia.
In France the drug is only authorised for the treatment of acne, however, ANSM has noted widespread off-label use as a contraceptive.
EU legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country.
PRAC will now evaluate all available evidence in regards to Diane 35 and its risk and benefits and announce its recommendation on whether its marketing autorisations should remain as they are or be varied, suspended or revoked for the safety of all patients in the EU by 16 May 2012.
It is now advising women currently taking Diane 35 to stop taking the drug and consult their doctor.
Diane 35 is also available in Australia under the trade names Brenda 35, Juliet 35, Estelle 35 and Laila.
Australian regulator, the Therapeutic Goods Administration, has issued a safety warning and is also undertaking a review of the drug.