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Federal health experts yesterday declared that at least six antidepressants may be dangerous to children ? and said they should be branded with bold labels warning they may make youngsters suicidal.
By a vote of 25-1, members of two Food and Drug Administration blue-ribbon panels agreed that drugs like Luvox, Effexor and Paxil made some youngsters more likely to think about killing themselves.
After the vote, the group of scientific advisers said antidepressants should come with the nation's strongest warning, in a black box on the label. The panel also wants a rule that pamphlets detailing the risks be included in the drug boxes, and asked that parents sign a form saying they understand the dangers before their children take the drugs.
The requests ? which the FDA is not required to follow ? came after two days of hearings about claims that antidepressants have been responsible for a spike in suicidal behavior among young people.
According to recent data, children aged 1 to 17 account for some 7 percent of antidepressants prescribed. On average, antidepressants cause an extra 2 to 3 percent of young people to have increased suicidal thoughts, another study found.
The drugs Luvox, Effexor and Paxil caused the highest risk of suicidal behavior among young people, while Celexa, Zoloft and were less dangerous. The FDA panel also found that underqualified people have some times been prescribing the drugs to children.
Only roughly 80 percent of prescriptions for such drugs are written by psychiatrists and pediatricians ? with nearly two-thirds being written by psychiatrists, said Michael Evans of the FDA's Office of Drug Safety.
This has led to use of such drugs in ways not indicted on the labels.
"The off-label use of these medications is fairly promiscuous," said Dr. Michael Fant, a panel member. "And the prescribers extend well beyond those who are trained in the care of the mentally ill."
The relatives of some young antidepressant users who have committed suicide have blamed the drug companies for trying to cover up the dangers of the drugs and have filed suit against them.
"Drug companies have purposely deceived the public about the safety and efficacy of their drugs," said Tom Woodward, whose 17-year-old daughter Julie hanged herself while she was on Zoloft.
During congressional hearings last week, critics said the FDA and drug companies have provided scant details of pediatric clinical trials for antidepressants. With Post Wire Services