Antidepressant warning issued

NEWS IN BRIEF — Posted June 12, 2006

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A Dear Healthcare Professional letter was sent last month by the manufacturer of the antidepressant Paxil, or paroxetine hydrochloride, and Paxil CR, its controlled-release version, urging physicians to monitor adult patients using the drugs for worsening of depression and signs of suicide. The medication already had carried warnings to monitor closely teens and young adults ages 18 to 24.

A recent meta analysis of the drug by its manufacturer, GlaxoSmithKline, found that patients using Paxil had a higher frequency of suicidal behavior than did those on placebo. The finding resulted in a label change expanding the warning to closely monitor adult patients, particularly those up to age 30.

"It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated," said the Food and Drug Administration in a May 12 posting on its MedWatch Internet site.

But the data should be interpreted with caution, the agency said, because although the number of suicide attempts was statistically significant among those who took the drug, the number of events was small -- 11 out of 3,455.

GlaxoSmithKline, which made the labeling changes voluntarily, said it was difficult to conclude that there is a causal relationship between the drug and suicide attempts because there were so few events and that the events themselves are symptoms of depression and other psychiatric illnesses that the drug is intended to treat.

Note: This item originally appeared at

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