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Can a drug be safe if an FDA warning has been issued for it?
Can a drug for which a Food and Drug Administration (FDA) warning has been issued be safe? The question of safety using off-label intravitreal bevacizumab (Avastin Genentech, South San Francisco, California, USA; Roche AG, Basle, Switzerland) is a concern among ophthalmologists around the globe. This is one of the key aspects of The international intravitreal bevacizumab safety survey: using the internet to assess drug safety worldwide published by A Fung et al1 (see page xxx). Why else would 70 centres from 12 countries voluntarily report on >7000 injections in >5000 patients using an internet-based questionnaire within just 6 months?
The safety survey reported no drug-related adverse events for intravitreal bevacizumab injections beyond the level of incidence rates seen in control groups of current anti-vascular endothelial growth factor (VEGF) trials in ophthalmology. No single adverse event reported was above 0.21% over a mean follow-up of 3.5 months. On the one hand, a self-reported safety survey may have the risk of underestimating adverse events, which was discussed by the authors; on the other hand, hardly any prospective clinical trial would be able to obtain safety data from such a diversity of centres, using different techniques for preparing and injecting bevacizumab and for …