Her doctor had prescribed Prozac off-label for an eating disorder. In 1993, he was successful in a suit that forced the FDA to relax its rules prohibiting drug companies from promoting off-label prescribing. A physician is free to use a medical device for an off-label purpose, if, in the...
For children, efficacy of such treatment remains difficult to judge as all SSRI use in paediatric care remains 'off-label' or unlicensed. Notwithstanding this, in 2006 the European Medicines Agency (EMEA) advocated the use of Prozac within the EU for children from the age of eight, a ...