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FDA Urges Softer Antidepressant Warning

With their feet held to the fire by a House subcommittee, the FDA will likely require antidepressants to carry strong, "black box" warnings about links between increased suicidal behavior in children who take the drugs. But that wasn't as big a bombshell as the one revealed by a government epidemiologist who 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 FDA managers in March, Andrew Mosholder told the subcommittee "alternative conclusions were offered to me, which I declined to incorporate into my written document." Rather than discourage the use of all antidepressants, save Prozac, for children, he was told to suggest that children use such medication "with caution."

Mosholder's reviews showed that Prozac, the only drug approved to treat depressed children, also posed the least risk for depressed children. The FDA rebutted Mosholder's statement, saying the epidemiologist wasn't pressured to change his review, just given suggestions he opted not to follow.

Testimony during a hearing by a House Energy and Commerce investigations subcommittee got very contentious because some committee members said the agency had been slow to warn patients of the increased risk linked to a new generation of antidepressants.

Rep. Peter Deutsch (D-Fla.) noted the FDA "behaved with such indifference to the public safety." News like this just strengthens my resolve to make my vision a reality.

Yahoo News September 23, 2004

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