Off-label usage

Pomerantz, Jay M., Stan N. Finkelstein, Ernst R. Berndt, Amy W. Poret, Leon E. Walker, Robert C. Alber, Vidya Kadiyam, Mitali Das, David T. Boss, and Thomas H. Ebert. 2004. Prescriber Intent, Off-Label Usage, and Early Discontinuation of Antidepressants. Journal of Clinical Psychiatry 65(3) 395-404. 

The use and safety of intralesional cidofovir for RRP was also investigated by another team, using a cross-sectional survey [3 ]. The survey was distributed to 82 surgeons, who collectively had managed 1248 RRP patients (including 447 children) in the previous lOyears. Adverse events reported by respondents included dysplasia (75 and 8, adults and children respectively), squamous cell carcinoma (14 and 3), acute kidney injury (0 and 5), and death (1 and 3). The authors recommend that when cidofovir is used in this context, there should be a documented discussion with patients of the risks versus the benefits and also that informed consent should be obtained for this off-label usage, with mention of risk of acute kidney injxuy in children. 

The MERCl Retriever and Penumbra systems have been approved by the FDA to remove blood clots from the brain in patients experiencing an ischemic stroke. The remaining drugs and devices constitute off-label and/or investigational (precUnical or clinical) usage... 

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