Think Stop before Going 'Off-Label' | Zendy

Gerald Y. Minuk | Zendy

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Think Stop before Going 'Off-Label'

Author(s) -

Gerald Y. Minuk

Publication year - 2004

Publication title -

canadian journal of gastroenterology

Language(s) - English

Resource type - Journals

eISSN - 1916-7237

pISSN - 0835-7900

DOI - 10.1155/2004/571283

Subject(s) - thalidomide , troglitazone , drug , medicine , off label use , clinical trial , drug approval , intensive care medicine , pharmacology , peroxisome , receptor , multiple myeloma

Only after careful and extensive review of all available safety and efficacy data derived from preclinical and clinical trials will a regulatory body approve the licensing of a drug for a specific medical condition ('indication'). Experience with thalidomide, fialuridine and troglitazone, to name a few, reveal that despite these efforts, the process is not infallible. What then can we expect when a drug is used for a medical condition in which no such review process has been undertaken ('offlabel' use of the drug)

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