European action needed to protect patients from unlicensed/off-label medicines, say patient groups

Four European patient organizations have published a consensus statement raising concerns about the unlicensed and off-label use of medicines, and calling for a professional Code of Practice. These were the European Alliance for Access to Safe Medicines, the European Federation of Neurological Associations, the European Men’s Health Forum and the European Depression Association

The consensus statement follows recent warnings by the US Food and Drug Administration about a cluster of serious eye infections in Florida associated with the off-label use of an unlicensed medicine, Roche’s Avastin (bevacizumab) which, because of its lower cost, is often used to treat wet-age-related macular degeneration instead of Roche/Novartis’ Lucentis (ranibizumab), which is FDA approved for that indication. Although the exact cause is currently under investigation, the common link for the infections is the repackaging of Aventis for use in eye clinics.

Whilst all the patients involved had visual defects before their injections with this unlicensed medicine, some patients lost all remaining vision in that eye due to endophthalmitis (an inflammatory condition in the eye usually caused by infection). There have since been other cases reported by the media in other parts of the USA. The New York Times reported five patients blinded through off-label eye injections in Los Angeles, and also reports another earlier situation in Tennessee which is subject to legal action. 2