Was Paxil approved by FDA? Why was it prescribed? What are the adverse side effects of taking Paxil?

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jun 19, 2018

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Paxil is an anti-depressant drug, approved by the FDA for use in adults suffering from depression, obsessive compulsive disorder, panic disorder, and social anxiety disorder. The FDA later approved Paxil for use in treating post-traumatic stress syndrome. The FDA never approved the use of Paxil for children; however, Glaxo-Smith-Kline, the manufacturer of Paxil, promoted the use of Paxil for children to doctors who believed that it was safe and effective.

Patients who have had Paxil prescribed for them have exhibited significantly increased suicidal and homicidal tendencies, resulting in suicide attempts, suicides, and homicides. In August of 2001, a jury awarded the relatives of a Wyoming man $8 million dollars in a wrongful death suit after the man, who had taken Paxil as prescribed by his Paxil is an antidepressant drug, approved by the FDA for use in adults suffering from depression, obsessive-compulsive disorder, panic disorder, and social anxiety disorder. The FDA later approved Paxil for use in treating posttraumatic stress syndrome. The FDA never approved the use of Paxil for children; however, GlaxoSmithKline, the manufacturer of Paxil, promoted the use of Paxil for children to doctors as safe and effective.

Babies of mothers who have taken Paxil during pregnancy have suffered from an array of birth defect side effects linked to SSRI (selective serotonin reuptake inhibitor) antidepressants. Heart defects that involve holes in heart walls have been particularly linked to Paxil.

Patients who have had Paxil prescribed for them have also exhibited significantly increased suicidal and homicidal tendencies, resulting in suicide attempts, suicides, and homicides. In August of 2001, a jury awarded the relatives of a Wyoming man $8 million dollars in a wrongful death suit after the man, who had taken Paxil as prescribed by his doctor, killed his wife, daughter, and granddaughter before killing himself. One of the claims made in the case was that the manufacturer had known since 1990 that Paxil could cause homicidal and suicidal tendencies in certain people, but had failed to adequately notify doctors and patients about these tendencies.

Additionally, in 2004 the Attorney General of New York negotiated a settlement over claims that the manufacturer had committed fraud by promoting the use of Paxil in children. The manufacturer was accused of concealing information from four different studies which concluded that Paxil was not only ineffective in treating depression in children, but that it greatly increased suicidal tendencies in children who took it.

Finally, although Paxil’s manufacturer marketed the drug for years as “non-habit forming”, many users found that they were unable to discontinue use of the drug, even under a doctor’s care, due to severe side effects including the feeling of electrical “zaps”, dizziness and vertigo, extreme nausea and vomiting, anorexia, aggression, irritability, sleep disturbances, sweating, and memory and concentration difficulties. Paxil became a drug that some patients were required to continue taking to keep these symptoms at bay. Nonetheless, it was 9 years after Paxil was first approved by the FDA before the FDA required stricter warnings about the side effects of withdrawal.

These increased suicidal and homicidal tendencies, in children and adults, as well as some patients’ inability to discontinue taking Paxil due to severe side effects have formed the basis for a number of cases against GlaxoSmithKline around the country.

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