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Prozac containing Fluoxetine is manufactured by Eli Lilly. It is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class. FDA approved Prozac on 29th Dec 1987 and introduced it in US market in 1988 for treating major depressive disorders, obsessive compulsive disorder (OCD), panic disorder, bulimia nervosa and premenstrual dysphoric disorder. Its off-label uses are migraine, ADHD, IBS, fibromyalgia etc.
Patients taking Prozac have experienced various adverse effects resulting in more mental, emotional and physical suffering. Prozac, if used during pregnancy, babies may suffer from birth defects including anencephaly, septal defects, damaged hearts or cleft lip or palate.
Major complications faced till date
- Risk of Birth defects including septal defect, Coarction of aorta, Hypoplastic Left Heart Syndrome (HLHS), Tetralogy of fallot, Transposition of great arteries, congenital lung and cranial defects, anencephaly, Down's syndrome, Undescended testes in males, Blindness, Hernia, Persistent pulmonary hypertension of the new-born, Autism spectrum disorder etc.
- Risk of Suicidal attempts and violent behavior in children, adolescents and young adults (Age group - 18 to 24)
- Increased risk of death in patients with coronary artery disease.
In May 1990, FDA has issued alerts regarding unreported side effects of Prozac leading to litigation, like suicidal and violent behavior, bulimia, stroke, hemolytic anemia in children, adolescent and in young adults (ranging from age 18 to 24).
In 2004, the FDA issued its first black-box warning against Prozac and specially alerted children, teenagers and health care practitioners about the possibility of suicidal behaviors and other deadly effects from the drug and in 2006 about birth defects and autism to unborn child when used during pregnancy.
Federal Prozac cases have been moved to the U.S. district court for Southern district of Indiana in 1992 by the federal judicial panel. Thousands lawsuits filed against Eli Lilly as Prozac causing violence and birth defects.
Eli Lilly had done settlements at least of $50 million for resolving more than 30 lawsuits, most of which were of homicide and suicide, by the year 2000.
Evidence to be looked for in potential cases
- Usage of Prozac in Pharmacy Records.
- Duration of Prozac usage in pregnant females and in children/young adults from Pharmacy Records
- Diagnosis and Treatment of birth anomalies in child; suicidal tendency and violent behavior in children/young adults after Prozac intake
- Treatment required for birth related defects in child.
Medical Record Review and claim validation of Prozac case should take approximately 2 hours in most instances; however, this approximation may vary in cases based on the volume of records.