WASHINGTON – Antidepressants should come with the nation’s strongest warning – in a black box on the label – that they can sometimes spur suicidal behavior in children and teenagers, the government’s scientific advisers decided Tuesday.
It’s a rare risk, and therefore families need detailed information on how to balance that concern with the need to treat depression, which itself can lead to suicide, cautioned advisers to the Food and Drug Administration.
So antidepressants prescribed to minors also should come with an easy-to-read pamphlet that explains how to decide if the child is an appropriate candidate and what are the warning signs of suicide, the panel concluded. Also, the FDA should consider the extra step of making parents sign a form that they understand the risks before the child receives the first pill.
There may be a backlash to such strong warnings, cautioned FDA advisory committee chairman Dr. Wayne Goodman, psychiatry chairman at the University of Florida.
“It will make prescribing more difficult. I anticipate there will be alarm from parents and the child,” said Goodman, who still backed the step on a 15-8 vote. “I think that’s worth that complication, because it will raise the threshold to prescribing” these drugs to minors.
The drugs seem to help some desperately ill children – even though only one, Prozac, has won FDA approval as effective for pediatric depression, said panelist Jean Bronstein, a California nurse who opposed the black-box warning.
“The biggest message I heard from the consumer 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 Tuesday’s decision with applause.
The FDA isn’t bound by its advisers’ recommendations but usually follows them. FDA drug chief Dr. Robert Temple said a decision could come within months but noted the advisers weren’t unanimous: “When the decision is divided, it’s less of a sure thing.”
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