GlascoSmithKline PAXIL Warning letter to Healthcare Professionals

GlascoSmithKline PAXIL Warning letter to Healthcare Professionals

Thu, 19 Jun 2003

On June 10 the British government disapproved a license the widely popular, SSRI antidepressant, Seroxat (PAXIL), for use in children and adolescents after a committee examined the data from 9 clinical trials. The British Medicine and Healthcare Products Regulatory Agency (MHPRA) issued a warning to doctors not to prescribe the drug to children because: “It has become clear that the benefits of Seroxat in children for the treatment of depressive illnesses do not outweigh the risks.” See: AHRP Infomail: http://www.ahrp.org/infomail/0603/10.php

AHRP has obtained copies of letters sent out by GlaxoSmithKline, the manufacturer of Seroxat (PAXIL), to British Healthcare Professionals in which the company’s Director of Medical Affairs lists the following “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.”

The government ban on the use of Seroxat (PAXIL)in children has the full endorsement of the Royal College of Psychiatrists (UK) http://www.rcpsych.ac.uk/press/preleases/pr/pr_417.htm

The Glaxo letters are posted on the AHRP website. The first revised the drug label, removing the claim that Seroxat (PAXIL) is not addictive.

The letter specifying the drug’s dangers is posted as 2 images.

Two years ago, a Wyoming jury in the United States awarded $6.4 million to the family of a patient taking the drug who murdered his wife, daughter and granddaughter and then committed suicide in what the family said was a reaction to the drug.

In March 2003, a British coroner asked the medicines control agency to withdraw Seroxat (PAXIL) pending an investigation when a retired headteacher committed suicide after taking the drug for two weeks. See: http://www.ahrp.org/infomail/0303/13.php

Inexplicably, the US Food and Drug Administration has kept out of this controversy, thereby failing to perform its mission–which is to protect the public from hazardous drugs and to inform physicians and the public about adverse drug effects.

How many children prescribed psychotropic drugs–including antidepressants, antipsychotics and stimulants–have died as a result?

Doctors are not informed about these drugs’ potentially lethal adverse effects. Are coroners informed?

Do FDA officials think American children deserve less protection from harmful drugs than do British, Canadian, French, or Irish children? (PAXIL has been banned for use in children in those countries).