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FDA blocked data on children and anti-depressants

WASHINGTON -- The government has repeatedly urged anti-depressant manufacturers not to publicize information that the pills could harm children, according to testimony at a congressional hearing Thursday.

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Food and Drug Administration regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives.

For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies, and in one case the agency reversed a manufacturer's decision to disclose that its drug was associated in studies with increased hostility and suicidal thinking among children.

During the hearing before the House Energy and Commerce subcommittee on oversight and investigations, members of Congress assailed the drug companies and the FDA for failing to give doctors and parents the information they needed to decide whether antidepressants would help or harm children.

Prozac is the only antidepressant approved by the FDA for children. But four other antidepressants were prescribed more frequently to people 17 and under between 1998 and 2002 -- Zoloft, Paxil, Wellbutrin and Celexa, according to the FDA.

Twelve of 15 studies of the popular antidepressants, known as selective serotonin reuptake inhibitors, failed to show that the drugs were effective in children.

When the committee began its investigation earlier this year, only three of those studies had been published, according to the committee. Several have been made public since then.

An internal FDA study and a study done by Columbia University at the FDA's request both concluded that, according to the drug companies' own trials, children were almost twice as likely to have suicidal thoughts or behavior if they took the drugs than if they took placebos.

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