U.S. Advisory Panel Calls for Stronger Warnings on Antidepressants September 22, 2004
News Summary
A U.S. Food and Drug Administration (FDA) panel has recommended that stronger warnings about suicidal tendencies be placed on antidepressants such as Paxil and Prozac, Reuters reported Sept. 14.The panel of outside experts called for placing a warning that antidepressants can increase the risk of suicidal thoughts and behaviors in certain children and teenagers in a prominent black box on the drug's label.
The warning comes after more than 25 clinical trials involving nine of the newest antidepressants found that children treated with the drugs were more likely to say that they had suicidal thoughts or actions.
The drugs involved in the study were Eli Lilly's Prozac; GlaxoSmithKline Plc's Paxil and Wellbutrin; Pfizer Inc.'s Zoloft; Forest Laboratories Inc.'s Celexa; Wyeth's Effexor; Solvay SA's Luvox; and Akzo Nobel NV's Remeron.
"The purpose is to put physicians on notice that this group of medicines can cause problems," said panel member Dr. James McGough, a child and adolescent psychiatrist from Los Angeles, Calif.
The makers of the antidepressants are concerned that a black-box warning would discourage the appropriate use of the drugs. Instead, they offered to work with the FDA to determine the most effective way to warn doctors, parents, and patients about the risk.
"When people with depression are left untreated, 15 percent will actually commit suicide," said Prozac maker Eli Lilly.
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