The American Medical Association has called for an official probe to gauge the impact of the US Food and Drug Administration’s recent changes to antidepressant labelling.
Last October, the FDA ordered that all antidepressants – including the widely-used selective serotonin reuptake inhibitors, but regardless of drug class – carry a black box warning of an increased risk of suicidal behaviour amongst children and adolescents, and began requiring pharmacies to distribute a Patient Medication Guide that emphasises the risks [[18/10/04b]], on the advice of one of its advisory committees [[15/09/04a]]. The European Medicines Agency called for similar warnings earlier this year [[26/04/05d]].
But at its annual meeting this week, the AMA concluded that a causal link between SSRI antidepressants and suicides had not been established. As a result, it has asked the FDA to monitor antidepressant use among this group, and make sure that the new labelling is not being interpreted “in a way that reduces access to these drugs for patients who might benefit from them, including children and adolescents.”
“The safe use of antidepressants in children and adolescents must consider the severity of the disorder being treated and the anticipated risks and benefits of treatment for each individual,” said AMA trustee Cyril Hetsko, noting that untreated depression clearly raises the risk for suicidal behaviour in young people.
The AMA also cited clinical evidence that the Eli Lilly’s SSRI Prozac (fluoxetine) is effective in treating children and adolescents with major depressive disorder, while noting that “longer and better-designed paediatric studies are needed to address safety and efficacy concerns.”