Subject: Sen. Schumer requests hold on Paxil for kids
FYI
Senator Charles Schumer held a press conference in
New York to announce that he had written to Mark McClellan,
FDA Commissioner to investigate the adverse effects of
Paxil, the SSRI antidepressant on children and teens, and to
"place a hold on the GlaxoSmithKline's request to sell Paxil for
children's use pending the outcome of this study."
Paxil (Seroxat) has been banned for use in children and teens in the U.K.,
Ireland, Canada, and France, following revelations that GlaxoSmithKline,
the drug's manufacturer, had failed to disclose life-threatening
information about the drug. The ban was announced after the UK
Medicine and Healthcare Products Regulatory Agency reviewed 9 studies
based on more than 1,000 children which "had shown that the risk of
suicidal thoughts and self-harm was two to three times greater among those
on
Seroxat (Paxil) than those on placebo."
Lisa VanSyckel, a mother, spoke about her 18 year old daughter's sudden
violent behavior after being prescribed Paxil. She told how her daughter
had cut herself repeatedly with knives and razors, and how she tried to
commit suicide when she was on the drug.
The FDA has not only failed to meet its responsibility to the public
by failing to ensure that severe drug effects are disclosed to prescribing
physicians and the public, but the FDA used its muscle--assisted by the
Justice Department--to coerce a Federal judge to "reconsider" her August
decision. The judge had ordered GSK to stop Paxil advertisements that
included
false claims about the drug being non-habit forming. Evidence from GSK
own documents show the contrary.
http://www.wral.com/health/1715207/detail.htmlIndeed, on May 10, GSK announced it would alter the drug label to eliminate
that claim in the U.K. after BBC broadcast a powerful investigative report
demonstrating the perils of Seroxat (Paxil).
See, Antidepressant Seroxat tops table of drug withdrawal symptoms,
Sarah Boseley, health editor, The Guardian. Saturday July 27, 2002.
http://www.guardian.co.uk/Archive/Article/0,4273,4469899,00.htmlSee: BBC Panorama. The Secrets of Seroxat. October 13, 2002
http://news.bbc.co.uk/1/hi/programmes/panorama/2310197.stmSee also, series about the addictive effects of Paxil in Citypages,
Paxil is Forever: doctor please, some more of these.
by Beth Hawkins
www.citypages.com/databank/23/1141/article10788.asp
The Alliance for Human Research Protection (AHRP) calls upon the
FDA to disclose the adverse effects suffered by children prescribed
all SSRI antidepressant drugs such as Paxil, Prozac, Zoloft.
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