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Posted on Thu, Sep. 23, 2004

FDA Warnings on Antidepressants Likely

Associated Press

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 Thursday.

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 depression.

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 Evaluation.

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 subcommittee.

Mosholder said his reviews showed that Prozac, the only drug approved to treat depressed children, also posed the least risk for depressed children.

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 hearing room.

"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 suicidal tendencies.

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 findings.

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, D-Mich.


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