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The Food and Drug Administration is urging doctors to keep a closer watch for signs of worsening depression and suicidal behavior in both adults and children taking some of the most popular antidepressants, even though no direct link between the drugs and suicide has been established.
While the advisory does not mandate stronger cautions, officials said they hoped the makers of 10 drugs would update labels voluntarily while the FDA continues to investigate a possible suicide risk from the drugs.
"We're basically telling physicians that depression may become worse and may lead to suicidal thinking or behaviors," said Dr. Russell Katz, director of neuropharmacological drug products for the FDA.
"We do not know if the drugs are causative; it may be a natural course of disease, but they should be aware that changes might occur."
The new advisory came six weeks after a panel of FDA experts urged closer monitoring of patients being treated with certain antidepressants, particularly those that regulate the brain hormone seratonin.
Warnings with the drugs already advise that side effects from the drugs may include agitation, anxiety and hostility.
But the new advisory aims to make those warnings more prominent, while underscoring the need for better monitoring of patients, particularly when they first start taking the drugs or when the dosage is changed.
The drugs are all relatively new antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin.
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