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GSK admits anti-depression drug side effects include increased suicide


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GlaxoSmithKline warns Paxil may raise suicide risk

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By Jennifer Corbett Dooren

Last Update: 2:44 PM ET May 12, 2006


WASHINGTON (MarketWatch) -- The Food and Drug Administration and GlaxoSmithKline PLC (GSK) said Friday a recent analysis of clinical trials involving its antidepressant Paxil showed a small increase in suicidal behavior in young adults.

The company said it conducted an analysis of studies that involved 8,958 patients on Paxil and 5,953 on placebo, or a fake pill.

"Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo," the FDA said in a statement posted to its Web site Friday. GlaxoSmithKline detailed the results of the analysis in a letter to health-care professionals and updated the drug's label to reflect the results. Paxil, and other antidepressants, already carry a black-box warning about a possible increase in suicidal thoughts and behaviors in children and adolescents.

One of the analysis included looking at adults with major depression and it found a small increase in the frequency of suicidal behavior among patients on Paxil compared with placebo.

"However as the absolute number and incidence of events are small, these data should be interpreted with caution," the FDA said.

Results of the analysis showed a higher frequency of suicidal behavior in young adults, although the finding did not reach statistical significance. It showed that 17 out of 776 young adults ages 18 to 24, compared with 5 out of 542 on placebo, reported an increase in suicidal behavior, such as thinking about suicide or attempting it. In people older than age 24 there was no increase overall.

But in an analysis of adults with major depressive disorder, it showed small but statistically significant increase in suicidal behavior among adults on Paxil. It showed that 11 out of 3,455 patients reported some type of suicidal behavior compared with 1 out of 1,978 patients on placebo. Eight of the 11 events were non-fatal suicide attempts and the majority of them occurred in adults ages 18 to 30.

Paxil's label had already recommended that doctors treating patients with major depression carefully watch their patients for worsening depression and the emergence of suicidal ideation and behavior.



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Im on a anti-depression drug called Citalopram, not paxil. It works great, I dont have any side effects other then having very strange dreams at night, every night, and when I mean strange, I mean strange, sometimes very bad dreams. I dont always look forward to going to sleep at night.

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I went on Zoloft 2 years ago for social anxiety(sp?) but have been taking it recently for depression. It is alright, no side effects except for very wierd dreams(Kinda like what Tealmarlin with Citalopram). I'm looking for something better though. I've been wanting to go on Prozac but my doctor dosen't think it is a good idea because he says it takes a month to kick in. I took it when my dad died when I was younger and my mom said I did well with it. Only side effect from it was I didn't eat.

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