Alliance for Human Research Protection

June 18, 2003.

GlaxoSmithKline, manufacturer of Paroxetine (Seroxat, Paxil) issued a letter addressed to Healthcare Professionals, disclosing that the drug was found be linked to serious undesirable effects in depressed children and adolescents under age 18. Below is an excerpt:

UNDESIRABLE EFFECTS Adverse events from paediatric clinical trials. In paediatric clinical trials the following adverse events, were reported at a frequency of at least 2% of patients and occurred at a rate of at least twice that of a placebo: decreased appetite, tremor, sweating, hyperkinesia, hostility, agitation, emotiona lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide. Suicidal thoughts and suicide attempts were mainly obsrved in clinical trials of adolescents with Major Depressive Disorder). In studies that used a tapered withdrawal regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine [Paxil] at a frequency of at least 2% of patients that occurred at a rate that was at least twice that of placebo were: nervousness, dizziness, nausea, emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide) and abdominal pain.

GSK also revised the package label, deleting the claim that this drug is not addictive.

Below are images of the GlaxoSmithKline letters sent to British healthcare professionals regarding Paroxetine (Seroxat, Paxil). The first letter concerns changes to the patient information leaflet, most of which also apply to adults. The second letter advises against use in treating children.

PLEASE NOTE: Click on the images for larger versions of each page (second letter has two pages).