Investigation

Senator Charles Grassley (R-IA) had asked the U.S. Food and Drug Administration (FDA) to investigate what GSK knew about the risk of adolescent suicide and Paxil, or paroxetine hydrochloride, which 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.

The investigation has now increased in scope to include the U.S. Attorney’s office in Boston, Massachusetts according to a story published in the Wall Street Journal last week. It is being alleged that GSK may have downplayed Paxil’s risk of suicide in adolescents to doctors and to the FDA. 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 and the FDA has since required GSK to provide a warning of those risks on the drug’s label.

Lawsuits over Paxil span the globe

U.S. patients are not the only ones who have brought lawsuits over Paxil. In fact, it was a British study on the links between adolescent suicide and Paxil (marketed there under the name Seroxat) that prompted the U.S. investigation. Although GSK was not charged with any wrongdoing in the British investigation, many believe that was simply due to differences in how data is collected in the United Kingdom. Patients there have brought another lawsuit against GSK alleging that the drug is defective in that it creates an addiction – even though the label specifically claims that it is not. Patients have not been able to get off of the drug without going through serious withdrawal.

It is estimated that nearly 100 million prescriptions of Paxil, which received FDA approval in 1992, are filled each year. 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.