Abstract
These are the updated French best practice guidelines initially released in 2007.1 In addition to the need to reappraise potential new evidence published since 2007, the following reasons motivated our revisiting of acne management: 1) Antibiotics: In particular, the World Health Organization claims the need to restrict antibiotic use to situations in which they are absolutely essential, in order to minimize the risk of emergence of bacterial resistance to antibiotics. Furthermore, after having analysed the risk/benefit ratio of minocycline, French health authorities withdrew its indication for acne treatment in 2012. 2) Isotretinoin: Controversies concerning the potentially increased risk of depression and inflammatory bowel diseases have emerged. 3) Hormonal therapy: In May 2013 the French Medicines Agency (ANSM) suspended the marketing authorization in France of medicinal products containing cyproterone acetate/ethinylestradiol (2 mg/0.035 mg).
It then asked the European Medicines Agency Pharmacovigilance Risk-Assessment Committee (EMA PRAC) to reassess concerns regarding hormone-therapy-associated thromboembolism to decide whether the marketing authorization for it should be maintained, varied, suspended or withdrawn. PRAC concluded that the benefits of cyproterone acetate/ethinylestradiol (2 mg/0.035 mg) outweigh the risks and recommended the implementation of measures to minimize the risk of thromboembolism.
Following this report ANSM withdrew the suspension.