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
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
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