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WARNING: Withdrawal Reactions With Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants

Dec 1, 2005 | A withdrawal reaction has been reported with all SSRI antidepressants: citalopram (CELEXA); escitalopram (LEXAPRO), fluoxetine (PROZAC, SARAFEM); fluvoxamine (LUVOX); paroxetine (PAXIL); and sertraline (ZOLOFT).

The symptoms generally start within one to three days after stopping the drug and generally resolve within one to two weeks after the drug has been discontinued. Withdrawal symptoms may occur even when the dosage of the drug is gradually decreased. The main symptoms of this reaction are dizziness, vertigo, incoordination, nausea and vomiting, and flulike symptoms that include fatigue, lethargy, muscle pain, and chills.

Healthcare professionals were notified on Sept. 27, 2005 that the professional product labeling for the selective serotonin reuptake inhibitor (SSRI) antidepressant paroxetine (PAXIL, PAXIL CR) was being updated to warn of major congenital malformations (birth defects), primarily heart malformations, in children born to women taking the drug during their first trimester of pregnancy.

Paroxetine was first marketed in the U.S. in December 1992 and last year, sales of the drug exceeded $824 million. Paroxetine is produced by GlaxoSmithKline of Research Triangle Park, NC.

The warning was based on a study that the FDA had asked GlaxoSmithKline to conduct. The study used two insurance company databases that store medical and pharmacy claims from health plans throughout the U.S. All women dispensed an antidepressant and who had delivered a live child between May 2000 and June 2003 were identified for the analysis.

The study suggested an over two-fold increase in the risk of major congenital malformations when paroxetine was taken compared to other antidepressants. This type of statistical research is not considered as reliable as a randomized “gold standard” study, which might support a conclusion that paroxetine causes birth defects. But it is more than sufficient to warn women of the possibility.

A more complete description of this study can be found on GlaxoSmithKline’s Web site at: paroxetine/epip083.pdf.

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