Last Updated: 2005-08-22 16:19:48 -0400 (Reuters Health)
By Karla Gale
NEW YORK (Reuters Health) – Adults taking the antidepressant Paxil (also known as Seroxat or paroxetine) should be monitored closely because the drug may increase the risk of suicide attempts, Norwegian investigators conclude after analyzing data primarily from unpublished studies.
The drug-maker, GlaxoSmithKline Plc, however, calls the results “flawed and misleading.”
In the journal 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 studies featuring a total of 916 patients treated with Paxil and 550 with inactive “placebo”. Most trials ran for 6 weeks, although one lasted for 17 weeks.
More suicide attempts were observed among patients treated with Paxil than among those who given placebo. The authors conclude that the use of selective serotonin reuptake inhibitors (SSRI), the drug class that includes Paxil, Prozac and Zoloft among others, is associated with “increased intensity per year of suicidal attempts.”
In an interview with Reuters Health, 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, “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.”
SOURCE: BMC Medicine, August 21, 2005.