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Incidence of Suicidality in Young Adults With Anxiety Disorders Treated With Paroxetine: Presented at ADAA

By Jill Stein

ST.LOUIS, MO -- April 3, 2007 -- New data suggest that while the suicidality rate is similar in paroxetine- and placebo-treated adult with nondepressive disorders overall, a higher (though not statistically significant) incidence of suicidality occurred in young adults treated with this drug than with placebo.

These findings in young adults are consistent with the overall paroxetine data -- which includes patients with both nondepressive and depressive conditions, according to a presentation on March 31^st at the 27^th Annual Meeting of the Anxiety Disorders Association of America (ADAA).

John E. Kraus, MD, PhD, director of clinical development, Neurosciences Medicines Development Center, GlaxoSmithKline, Research Triangle Park, North Carolina, United States, reported data in 8,931 paroxetine- and placebo-treated patients aged 18 to 24 years enrolled in clinical trials in nondepressive disorders (mostly anxiety disorders).

For the analysis, rates of definitive suicidal behaviour and definitive suicidal behaviour or ideation were compared between treatments.

The investigators found no significant differences between paroxetine and placebo on either of the suicidality endpoints for the entire cohort, which included patients with panic disorder, social anxiety disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, fibromyalgia, and alcoholic patients.

Likewise, there was no significant difference between paroxetine and placebo on any suicidality endpoint when each nondepressive indication was assessed individually.

A higher but not statistically significant incidence of suicidal behaviour with or without ideation occurred in young adults treated with paroxetine versus placebo (5/504 [0.99%] versus 1/393 [0.25%] for the 2 groups respectively, OR = 3.9 [95% CI 0.5, 93.7]).

"It is important that all patients being treated with paroxetine, especially young adults, be closely monitored during therapy, regardless of the condition being treated," Dr. Kraus said.

The recommendation for close monitoring also extends to patients who are showing an improvement with therapy, he added.

The study was sponsored by GlaxoSmithKline.


[Presentation title: Suicidality Incidence in Paroxetine Adult- Non-Depression Studies. Abstract P104]

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