Sen Schumer asks FDA to place hold on Paxil for kids

Fri, 13 Jun 2003

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.html

Indeed, 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.html

See: BBC Panorama. The Secrets of Seroxat. October 13, 2002 http://news.bbc.co.uk/1/hi/programmes/panorama/2310197.stm

See 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.