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When Did Makers Of Paxil Know About Risk Of Suicide In Kids?

GlaxoSmithKline (GSK), the maker of the popular antidepressant drug Paxil, may have known for years about the risks of suicide in adolescents now being linked to the drug. That’s what Iowa Senator Charles Grassley is claiming and he’s asked the U.S. Food and Drug Administration (FDA) to investigate what GSK knew and when they knew it.

The investigation

Senator Charles Grassley (R-IA), along with other senators, has asked the FDA to investigate whether GSK knew about the risks of suicide in adolescent patients who have been prescribed the antidepressant drug, Paxil. Grassley asked the FDA to investigate following a report from a British regulatory agency that suggests GSK knew about these risks since 1998, but withheld the information from the FDA and consumers.

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What is Paxil?

Paxil, or paroxetine hydrochloride, is an SSRI (selective serotonin reuptake inhibitor) prescribed for the treatment of depression, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, post traumatic stress disorder and social anxiety disorder. Manufactured by GSK, Paxil received FDA approval in 1992 and it is estimated that nearly 100 million prescriptions are filled each year. Although Paxil was not approved for use by anyone under the age of 18, experts say that many doctors have prescribed the drug to adolescents for a variety of off-label uses. According to the drug’s website, www.paxilcr.com:

Paxil CR is approved only for adults 18 years and over. In some children and teen, antidepressants increase suicidal thoughts or actions. Young adults, especially those with depression, may be at increased risk of suicidal actions.

The FDA required that GSK add the above warning in 2004; however, many believe that the company knew of the increased risks of suicide for years beforehand, but failed to provide that information to the FDA and consumers. If you believe your child was harmed by Paxil, contact an attorney whose practice focuses in this area of the law to discuss your situation. Consultations are free, without obligation and are strictly confidential. To contact an experienced attorney, please click here. We may be able to help.

Suffered harm from Paxil? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights. [Sponsored link]



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