Guest guest Posted August 7, 2004 Report Share Posted August 7, 2004 > JustSayNo > Fri, 6 Aug 2004 07:31:29 -0400 > [sSRI-Research] PAXIL SUICIDE STUNNER > > PAXIL SUICIDE STUNNER > > http://www.nypost.com/cgi-bin/printfriendly.pl > > By SUSAN EDELMAN > > -- > > August 1, 2004 -- EXCLUSIVE > > The manufacturer of controversial antidepressant > Paxil found in its own trials that children on the > drug went though hellish ordeals of " out of control " > behavior, suicide threats, hallucinations and > hospitalization, records show. > > Those reports, obtained by The Post, are among 400 > case studies of " adverse events " that led a > scientist for the Food and Drug Administration to > conclude that most antidepressants raise the risk of > suicide in children. > > At least 110 American kids have killed themselves > while taking antidepressants during the past decade, > new FDA data says. > > With U.S. doctors continuing to prescribe Paxil and > other antidepressants to millions of kids, the FDA > is now considering whether to issue stronger > warnings or advise against their use, as Great > Britain has done. > > The Post reviewed a sampling of reports of children > who suffered horrific events during Paxil clinical > trials from 1994 to 2001. One internal document > lists 23 children and teens as making suicide > attempts. > > The kids swallowed handfuls of pills such as > Tylenol, " self-mutilated, " or did other > " self-damaging acts, " it states. > > > > Other examples of alarming behavior outlined in the > documents include: > > * A 10-year-old boy taking Paxil for two weeks > " became violent and out of control with aggressive > and agitated behavior toward himself. " He ran away > from home and was put on suicide and escape watch in > a children's psychiatric ward; > > * An 11-year-old girl on Paxil for two weeks was > hospitalized after telling her mom " she wanted to > hang herself from the ceiling fan. " > > * An 11-year-old boy " held a knife to his wrist and > threatened to harm himself " two days after stopping > Paxil. > > * A 14-year-boy on Paxil for two weeks became > enraged, punched pictures, broke glass and suffered > deep cuts. After his anger eased, " He expressed > hopelessness and possible suicide thoughts. " > > In some cases, investigators working for Paxil > manufacturer GlaxoSmithKline said the behavior was > " possibly related " to taking Paxil; in others, they > blamed the children's depression, mental disorder or > family problems. > > In recent weeks, GSK has begun posting on its Web > site some previously unpublished studies after state > Attorney General Eliot Spitzer accused the company > of fraud for withholding reports of kids who became > violent or suicidal. But many documents remain privy > only to GSK or under seal in lawsuits, sources said. > > > The FDA has now asked a group of Columbia University > doctors to review the reports to determine whether > antidepressants may have triggered the suicide > attempts and other dangerous behavior in children. > > Earlier this year, a scientist in the FDA's own > Office of Drug Safety, Dr. Andrew Mosholder, found > that kids on antidepressants became suicidal twice > as often as kids on sugar pills. > > But FDA brass reacted coolly to his bombshell > opinion. The agency forbade Dr. Mosholder to present > his findings at a hearing in February or to discuss > them, officials acknowledged. > > Mosholder told Senate investigators he was pressured > to change his recommendation, but refused. > > " We feel that further research is needed before we > come to a conclusion, " FDA spokeswoman Susan Cruzan > told The Post. She called Mosholder's suicide-link > " premature. " > > The FDA has warned doctors to beware of suicidal > behavior when prescribing antidepressants to kids. > > In defending its pediatric trials, a spokesman for > GSK said that " not a single person " of more than > 1,000 patients committed suicide. > > " Any adverse event is taken seriously by the > company, " spokesman Rick Koenig said Friday. > > > [Non-text portions of this message have been > removed] > Quote Link to comment Share on other sites More sharing options...
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