Antidepressants should come with a strong warning -- in a black box on the label -- that they sometimes can spur suicidal behavior in children and teenagers, the government's scientific advisers decided yesterday.
Antidepressants prescribed to minors also should come with a pamphlet that explains how to decide whether the child is an appropriate candidate for the drug and what are the warning signs of suicide, the panel of Food and Drug Administration advisers concluded. It also was recommended that FDA consider the extra step of making parents sign a form that they understand the risks before the child receives the first pill.
But there may be a backlash to such strong warnings, cautioned FDA advisory committee Chairman Dr. Wayne Goodman, chief of the psychiatry department at the University of Florida.
"It will make prescribing more difficult," he said. "I anticipate there will be alarm from parents and the child. I think that's worth that complication, because it will raise the threshold to prescribing" these drugs to minors.
On the other hand, the drugs seem to help some desperately ill children, said panelist Jean Bronstein, a California nurse who opposed the black-box warning but said patients and their parents need to be aware of the risks.
"The biggest message I heard from the consumers is they want to be warned about what the risk is," she said, referring to hours of emotional testimony Monday from families who blamed their children's suicides on drugs they didn't know might be risky.
Tearful families greeted the panel's conclusions with applause.
The FDA isn't bound by its advisers' recommendations, but it usually follows them and has indicated that it is eager to update the warnings on antidepressant labels. They state that a link between suicidal behavior and antidepressants hasn't been proved.
The FDA's latest analysis marks a sharp reversal of that position: For every 100 youths given an antidepressant, two or three may display increased suicidal thoughts or behavior owing to the drug.
Debate erupted last year when British health authorities declared that most popular antidepressants might increase the risk of suicidal behavior in children and teenagers. They declared all but one -- Prozac -- unsuitable for depressed youths, but stopped short of a ban.