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Adult Suicides Linked to Paxil

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http://www.redherring.com/PrintArticle.aspx?a=13264 & sector=Industries

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Adult Suicides Linked to Paxil

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A new analysis reports that Glaxo's antidepressant is associated with a

higher risk of suicide in adults.

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August 22, 2005

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A new analysis by Norwegian scientists published on Monday has linked

GlaxoSmithKline's antidepressant Paxil to a higher risk of suicide

attempts in adults.

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The new statistical results, reported in the journal BMC Medicine, are

based on clinical data from 16 trials presented to the world's drug

regulatory agencies in 1989.

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The University of Oslo researchers found seven adult suicide attempts in

patients taking Paxil, but just one attempt in those given a placebo,

adding to evidence suggesting that a group of drugs called SSRIs

(selective serotonin reuptake inhibitors) carry significant risk.

Paxil is marketed as Seroxat in the United Kingdom.

" Although we report a small data set, by taking various priors into

account, the data strongly suggest that the use of SSRIs is connected

with an increased intensity of suicide attempts per year, " said the

study.

" We also conclude that the recommendation of restrictions on the use of

paroxetine [Paxil] for children and adolescents recently conveyed by

regulatory agencies should be extended to include usage by adults, "

added the researchers.

The drug's label already includes warnings that short-term studies in

children and adolescents with Major Depressive Disorder and other

psychiatric disorders have shown an increased risk of suicidal thinking

and behavior.

Conflicting Studies

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However, not all studies of SSRIs have demonstrated a higher risk of

suicide. A study of data from more than 40,000 people published in the

British Medical Journal (BMJ) in February could not find increased risk

of suicide in the group taking Paxil.

However, it did report " weak evidence " of an increased risk of self-harm

among patients taking the drug, noting that this was likely

underreported by patients.

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" Increased risks of suicide and self-harm caused by SSRIs cannot be

ruled out, " concluded the BMJ paper. " Any such risks should be balanced

against the effectiveness of SSRIs in treating depression. "

The Norwegian researchers contend, however, that this study did not

properly include data about Paxil, such as the length of time that

patients had been taking the drug.

" Patients and doctors should be warned, " they wrote.

GlaxoSmithKline said it is examining the study, and plans to release a

statement Monday regarding it.

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Shares of GlaxoSmithKline were up $0.19 to $48.40 in recent trading.

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© 1993-2005 Red Herring, Inc. All rights reserved.

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