Saturday, May 13, 2006

Suicide risk in taking PAXIL

GlaxoSmithKline Plc warned doctors that adults under the age of 30 may face an elevated risk of suicide attempts while taking its Paxil (paroxetine) antidepressant, extending beyond children the group that may be vulnerable.

A new analysis of data from clinical trials involving almost 15,000 people found suicidal behavior was more likely in adults taking Paxil for depression than in those getting a placebo. The majority of the attempts were in young adults ages 18 to 30. Among older adults taking the drug for any psychiatric disorder, no similar increase was seen.

The analysis is the first from a request by the U.S. Food and Drug Administration for all makers of anti-depression drugs to evaluate whether their medications increased the risk of suicidal thinking or actions among adults. A similar analysis in children led to warnings on drugs including Paxil, Eli Lilly & Co.'s Prozac, Pfizer Inc.'s Zoloft and Wyeth's Effexor in 2004.

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In a multi-state complaint, Michigan Attorney General Mike Cox alleged that GlaxoSmithKline unlawfully used the patent approval process and the court system to improperly extend the patent and monopoly on Paxil. This action allegedly caused a delay in the release of more cost-effective generic versions. Consequently, state Medicaid programs and other state programs paid more for the drug than they would have if the generic versions of the drug reached the market sooner. Cox announced on April 12, 2006 that Michigan, along with 48 other states, has reached a settlement with drug manufacturer GlaxoSmithKline involving the anti- depressant prescription drug Paxil. GlaxoSmithKline is to reimburse the state approximately $370,000 for overpayments made by the state's Medicaid and other healthcare programs.


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