2006 Medical Product Safety Alerts ...............Paxil

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2006 Medical Product Safety Alerts, listed in reverse chronological

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http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil

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Paxil (paroxetine hydrochloride) Tablets and Oral Suspension

Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets

Audience: Neuropsychiatric and other healthcare professionals

[Posted 05/12/2006] GlaxoKline (GSK) and FDA notified

healthcare professionals of changes to the Clinical Worsening and

Suicide Risk subsection of the WARNINGS section in the prescribing

Information for Paxil and Paxil CR. These labeling changes relate to

adult patients, particularly those who are younger adults.

A recent meta-analysis conducted of suicidal behavior and ideation

in placebo-controlled clinical trials of paroxetine in adult

patients with psychiatric disorders including Major Depressive

Disorder (MDD), other depression and non-depression disorders.

Results of this analysis showed a higher frequency of suicidal

behavior in young adults treated with paroxetine compared with

placebo. Further, in the analysis of adults with MDD (all ages), the

frequency of suicidal behavior was higher in patients treated with

paroxetine compared with placebo. This difference was statistically

significant; however, as the absolute number and incidence of events

are small, these data should be interpreted with caution. All of the

reported events of suicidal behavior in the adult patients with MDD

were non-fatal suicide attempts, and the majority of these attempts

(8 of 11) were in younger adults aged 18-30. These MDD data suggest

that the higher frequency observed in the younger adult population

across psychiatric disorders may extend beyond the age of 24.

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.

[May 2006 - Dear Healthcare Professional letter - GlaxoKline]

[April 2006 - Paxil Label - GlaxoKline]

[April 2006 - Paxil CR Label - GlaxoKline]

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