« Off-Label » Drug Use – Ethical Challenges - Case Study - AVASTIN®

Daniel Constantin Branisteanu, Mihnea Munteanu, Daciana Elena Branisteanu, Horia Tudor Stanca, Andreea Moraru, Florian Balta


« Off-label » administration of certain drugs has represented a common practice in medicine in the latest decades. Even if this attitude can be sanctioned with full responsibility transfer to the prescribing doctor, there is no law to punish this kind of practice if, from ethical point of view, the main purpose was to offer the best therapeutic option according to a significantly clinic experience and the patient has been correctly informed and consented about the status of the therapy, risks and advantages.

In particular, in ophthalmology, bevacizumab (AVASTIN®) is widely used « off-label » since 2005, even though not approved for intravitreal injections, main reasons being similar efficacy and significantly lower costs as compared to approved drugs. In Romania, « off-label » use of bevacizumab has started in 2007 and, until recently, has represented the only chance for patients with certain invalidating eye conditions. Even if, starting this year aflibercept (EYLEA®) is officially available, « off-label » treatments with bevacizumab are expected to maintain a significant percentage until the Health Insurance will reimburse, at least in part, much higher costs for using approved drugs.              

Key Words:  « off-label » drugs, bevacizumab, intravitreal use; 

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