WASHINGTON - The Food and Drug
Administration is likely to require antidepressants to carry strong,
"black box" warnings about links between increased suicidal behavior
in children who take the drugs, an agency official said
A decision could come "within a few days," said Dr. Robert
Temple, director of the Office of Medical Policy within the FDA's
Center for Drug Evaluation and Policy.
Testifying before a House subcommittee, Temple said patients also
would receive information guides with every prescription on how to
balance the risk of suicide with the benefits of treating
Two FDA advisory committees last week recommended the stronger
warnings and information pamphlets.
Temple testified at an often contentious hearing by a House
Energy and Commerce investigations subcommittee. Some committee
members said the agency had been slow to warn patients of the
increased risk linked to a new generation of antidepressants.
Also Thursday, a government epidemiologist said his bosses asked
him to soften his recommendation that most antidepressant use by
children be discouraged because of increased suicidal behavior among
young people who took the drugs.
During discussions with his managers at the Food and Drug
Administration in March, "alternative conclusions were offered to
me, which I declined to incorporate into my written document," said
Andrew Mosholder, who works in the FDA's Division of Drug Risk
Instead of discouraging the use of all but one antidepressant,
Prozac, for children, he was told to suggest that children use such
medication "with caution," Mosholder told the House
Mosholder said his reviews showed that Prozac, the only drug
approved to treat depressed children, also posed the least risk for
It's standard for superiors to review conclusions to ensure
they're supported by the evidence, countered Dr. Paul Seligman,
acting director of the agency's Office of Drug Safety, outside the
"That was done in this case. There was never any pressure to
change what he wrote," Seligman said. He termed managers' comments
as "suggested language" that Mosholder could adopt or ignore. "He
chose not to use it."
As is normal, the managers voiced their dissenting views in a
cover letter, Seligman said.
On Thursday, some members of the House subcommittee accused the
FDA of a pattern of deception.
"No agency charged with protecting the public health should have
behaved with such indifference to the public safety as is evidenced
in this case," said Rep. Peter Deutsch, D-Fla.
Mosholder told the panel that by last December his work confirmed
his preliminary analysis that found that children taking Paxil and
seven other antidepressants suffered increased suicidal behavior
more often than children taking sugar pills.
That finding was confirmed by an FDA senior reviewer who found
that for every 100 children taking antidepressants in controlled
clinical trials, an additional two to three experienced increased
Mosholder said the FDA deferred action on his recommendations so
it could confirm, through internal and external analyses, that the
warning signs were legitimate.
At the same time, British regulators acted swiftly, strongly
cautioning against prescribing antidepressants other than Prozac to
children. That alarmed the investigative panel.
Mosholder told the subcommittee that he was not allowed to
present his findings at an FDA advisory meeting last February, and
that he found himself the target of an internal affairs
investigation seeking the source of a leak to the media about those
Deutsch said the FDA attempted, without success, to force
Mosholder to sign a document that eliminated all mention of the
investigation. Contradicting Deutsch's statement, Mosholder
testified he was not asked to sign the statement, but to simply
present the edited document to the Senate. Acting on the advice of
his attorney, Mosholder used his own summary.
Rep. Joe Barton, R-Texas, chair of the investigative panel, said
the agency's actions with Mosholder continued a pattern of deception
that began as early as eight years ago. In 1996, Dr. James Knudsen,
an FDA medical reviewer, linked Zoloft with increased suicidal
thoughts and actions by suicidal children. In 1997, Mosholder raised
concerns that Luvox heightened hostility among just depressed
children, not adults taking it, Barton said.
"This hearing illustrates a larger problem at FDA, where too
often drug companies trump parents, where medical evidence is
suppressed and where expert opinion is silenced," added Bart Stupak,
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