Off-label use of baclofen for alcohol use disorders in India: no ethics without science.

Abstract

Off-label use of drugs, when not supported by sound scientific evidence, hinders the development of evidence-based medicine and therapeutic innovation, is costly to the healthcare system, and exposes patients to unnecessary risks, including mortality, for an uncertain benefit. Off-label use of baclofen is the preferred pharmacotherapy for alcohol use disorders in India, despite its negative benefit/harm ratio, and the fact that acamprosate or naltrexone have long been established as robustly evidence-based medicines. This unacceptable state of affairs only illustrates the fact that the marketing strategies of industry cannot be the sole basis for prescribing a drug.