Meta-Analysis Suggests Paroxetine May Increase Suicidality in Adults

— By Karla Gale —

NEW YORK (Reuters Health) Aug 22 - Adults taking the antidepressant paroxetine should be monitored closely because the drug may increase the risk of suicide attempts, Norwegian investigators conclude after analyzing data accrued primarily from unpublished studies.

The drug-maker, GlaxoSmithKline Plc, however, calls the results “flawed and misleading.”

In the August 21st issue of BMC Medicine, Dr. Ivar Aursnes and his associates at the University of Oslo analyzed clinical data “presented to the world's drug regulatory agencies in 1989.” They included 16 double-blind, placebo-controlled studies (916 patients randomized to paroxetine and 550 to placebo). Most trials ran for 6 weeks, although one lasted for 17 weeks.

The group documented seven suicide attempts during 190.7 patient-years of paroxetine use and one attempt during 73.3 patient-years on placebo. They conclude that the use of selective serotonin reuptake inhibitors (SSRI) is associated with “increased intensity per year of suicidal attempts.”

In an interview with Reuters Health, Dr. Aursnes acknowledged that they cannot rule out the possibility that the differences between groups were due to chance alone. However, he said, “I think when our figures are added to observations in other studies, together they are rather convincing that there is increased rate of suicide attempts” with SSRIs.

He added that “if patients express suicidal ideation, I think they should be given these drugs under controlled conditions like in a hospital or in a family setting where they can be looked after.”

In general, he believes that antidepressants “are used too extensively in patients today,” and that future research should include longer trial periods.

In a statement, GlaxoSmithKline said the analysis was misleading, focusing on incorrectly selected data, collected 15 years ago when the company was seeking approval for the drug.

”It serves only to cause confusion and unnecessary concern for patients using an SSRI, such as paroxetine, for treatment of depression,” GlaxoSmithKline said. “The sub-analysis also fails to acknowledge the current body of data, which is significantly more extensive and which has been recently reviewed by EU authorities.”

BMC Medicine 2005;3:14.

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