The “black box” warning, the strongest government alert, must also clearly state whether the drug is approved for use by children. Currently, only Eli Lilly’s Prozac is FDA-approved for pediatric use.
In a statement Friday the American Psychiatric Association raised concerns over the new requirement.
“We restate our continued deep concern that a ‘black box’ warning on antidepressants may have a chilling effect on appropriate prescribing for patients. This would put seriously ill patients at grave risk,” the statement said.
They added, “Recent prescription data suggest the current controversy over antidepressants has already lowered treatment rates; the new black box warning may further negatively impact treatment rates.”
The FDA says the new language serves only as a warning for the potential risk.
“The new warning language does not prohibit the use of antidepressants in children and adolescents. Rather it warns of the risk of suicidal (behavior) and encourages prescribers to balance this risk with clinical need,” the FDA said.
The second part to the FDA’s strategy to warn consumers is an information guide distributed with the antidepressant medication, advising parents to look for warning signs in their children.
The FDA will work with manufacturers to implement “unit of use” packaging for all antidepressants and ensure a MedGuide with every prescription. The “unit of use” packaging means the medication will be sealed and pre-labeled by the manufacturer with the amount for “one normal course of therapy.”
Today’s announcement follows last month’s Congressional hearing on antidepressants where a top FDA official said they would probably add a warning.
During the hearings, members of the House Energy and Commerce Committee said the FDA failed to recognize obvious problems with the drugs, though agency representatives disagreed, saying they had already been looking for ways to handle the safety concerns.
FDA analysis found as many as two or three of every 100 young people who are treated with antidepressants may face elevated risk of suicidal thoughts, Reuters reported. No child or teen actually committed suicide in the nine trials of antidepressants.