• Prozac Medical Record Review & Outsourcing Services

Prozac (Fluoxetine) manufactured by Eli Lilly is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class. The Food and Drug Administration (FDA) approved Prozac on 29th Dec 1987 and introduced it to the U.S. 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 for a 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, may result in babies with birth defects including anencephaly, septal defects, damaged hearts or cleft lip or palate.

Serious Alleged Injuries may include:

  • 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
  • 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.

FDA Safety Warnings:

  • In May 1990, the FDA issued alerts regarding unreported side effects of Prozac like suicidal and violent behavior, bulimia, stroke, and 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 behavior and other deadly effects of the drug
  • In 2006, warnings were included to the label about birth defects and autism to the unborn child when used during pregnancy.
  • In 2007, the FDA required antidepressant manufacturers to update existing black box warnings about the increased risks of suicidal thoughts and behavior during initial treatment in the first one to two months.
  • In January 2013, the FDA approved updated labeling information for Prozac to reflect Monoamine Oxidase Inhibitors (MAOIs), Serotonin Syndrome, Pregnancy.
  • In July 2014, the FDA required drug manufacturers to include an additional warning on the labels of Prozac including other medicines for treating a major depressive disorder. The warning was related to a potential complication caused by pupillary dilation, a side effect antidepressants, called angle-closure glaucoma.

Legal Updates:

Eli Lilly faced several lawsuits since the 1990s alleging it failed to warn that the drug could cause violent behaviors and suicidal thoughts. More lawsuits were filed when the FDA warnings for increased risk of birth defects were announced.

In 1992, a federal judicial panel moved 75 federal Prozac cases to multidistrict litigation (MDL) 907 (In re Eli Lilly & Co., Prozac Products Liability Litigation before Judge Dillin) in the U.S. District Court for the Southern District of Indiana. Hundreds of individual cases were filed across the country.

Eli Lilly provided at least of $50 million as settlement amount for resolving more than 30 lawsuits, most of which were of homicide and suicide by the year 2000.


  • 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.



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