The return of Diane 35 to pharmacy shelves

Publié le : 2 August 2013

 On Tuesday 30 July, the European Commission instructed France to relaunch the third generation contraceptive pill, Diane 35. However, the Agence nationale de sécurité du médicament (ANSM) (French National Agency for the Safety of Medicines and Health Products) opted for "a procedure to suspend the marketing authorisation" of the medicinal product in question and its generics – a measure introduced on 21 May 2013. In view of the increased risk of venous thrombosis and pulmonary embolism, the ANSM considers that this anti-acne drug, which is widely prescribed as a contraceptive, has an unfavourable benefit/risk ratio.      

The European Commission based its decision on conclusions reached by the Pharmacovigilance Risk Assessment Committee, who believed the drug to have "a favourable benefit/risk ratio". However, the product can only be relaunched on the market subject to certain conditions which must be taken into consideration by Bayer – the company marketing the drug. Brussels has stated that the anti-acne product must be used as a last resort "after topical treatment or systemic antibiotics has/have failed". It is still contraindicated in patients with a history of or hereditary predisposition for venous thrombosis", must not be prescribed in the treatment of alopecia and cannot be administered "concomitantly with another hormone contraceptive". Finally, the European Commission is demanding a review of the Patient Information Leaflet and Summary of Product Characteristics.

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