FDA Warns Paxil Increases Suicide Risk Among Young Adults
Posted on: Monday, 15 May 2006, 12:06 CDT
By Kyodo News International, Tokyo
May 13--WASHINGTON -- The U.S. Food and Drug Administration warned Friday that the antidepressant Paxil increases the suicide risk for young adults aged 18 to 30.
The drug, generically called paroxetine hydrochloride, is produced by Britain-based GlaxoSmithKline Plc., and is marketed in Japan and many other countries.
The FDA and the company said they have sent warning letters to doctors and informed them of changes to labels for Paxil and Paxil CR, a controlled-release version of the drug.
"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," the FDA said.
A recent meta-analysis of clinical trials on some 15,000 patients given Paxil and placebo tablets showed a higher frequency of suicidal behavior in young adults treated with Paxil, GlaxoSmithKline said.
Of the patients treated with Paxil, 11 attempted suicide -- all non-fatal -- and eight of them were younger adults aged 18 to 30, the company said. Only one of the patients given the placebo tablets attempted suicide.
"As the absolute number and incidence of events are small, these data should be interpreted with caution," the FDA noted.
In 2004, the FDA warned of pediatric suicide risk and ordered strong warning labels on antidepressant drugs. It has since been studying suicidal tendencies among adults.
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Copyright (c) 2006, Kyodo News International, Tokyo
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GSK,
Source: Kyodo News International, Tokyo
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