The Food and Drug Administration on Friday ordered that all antidepressants carry "black box" warnings that they "increase the risk of suicidal thinking and behavior" in children who take them.
Patients and their parents will be given medication guides that include the warning with each new prescription or refill.
The action came after an advisory committee to the FDA recommended the placement of the warnings regarding the suicide risks of certain antidepressants when prescribed for children and adolescents.
Lester Crawford, M.D., acting FDA commissioner, said the agency based its decision on the "latest and best science."
"We continue to believe, however, that these drugs provide significant benefits for pediatric patients when used appropriately," he told reporters.
"Antidepressants increase the risk of suicidal thinking and behavior ... in children and adolescents with major depressive disorder and other psychiatric disorders," the warning begins. Those risks must be balanced against clinical need, the label indicates in a warning surrounded by a black box, hence the "black box" designation.
The information guide, available within weeks for patients and their parents, echoes those warnings.
The FDA's action was driven by data that showed that on average, 2% to 3% of children taking antidepressants have increased suicidal thoughts and actions. Independent experts, working with Columbia University, based the finding on a review of data from 24 trials that involved more than 4,400 patients taking antidepressants. They found a greater risk during the first few months of treatment.
Crawford said suicides among youths decreased by 25% in the last decade, as antidepressant prescriptions to children soared. Children aged 1 to 17 now account for 7% of all antidepressant prescriptions.
Researchers say that although antidepressants were found to slightly increase the risk of suicidal thoughts and behavior in children, the drugs appear to have an even more powerful affect in preventing actual suicide.
The American Psychiatric Association expressed concern that the agency's actions may lead to fewer antidepressant prescriptions for patients most in need. "This would put seriously ill patients at grave risk," the association said in a statement.
The FDA said concern was raised during advisory committee meetings and in its internal discussions. Still, the black box is the best way to ensure patients and doctors discuss the risks and benefits of the drugs.
Doctors and families are asked to have at least weekly face-to-face contact with a child taking an antidepressant during the first four weeks of treatment. Biweekly visits would occur for eight more weeks and, as needed, after week 12.
The warning notice says caregivers and physicians should be equally as vigilant with adults who take antidepressants.
Because the FDA chose its most strident alert, the warning must be included in advertising. That means a trend that startled federal advisers -- free samples of antidepressants given to treat other medical conditions -- also must carry warnings.
The new warnings will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
