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Selective serotonin reuptake inhibitors (SSRIs) are typically used in the treatment of major depressive disorder and anxiety disorders that work by altering the levels of a mood-enhancing chemical called serotonin. First SSRI introduced in market was fluoxetine in 1985.

SRI are indicated in the treatment of major depression, anxiety disorder, panic disorder, social anxiety disorder, social phobia, bulimia nervosa, obsessive-compulsive disorder, personality disorder, premenstrual disorder and posttraumatic panic disorders. Off-label use of SSRI are migraine, diabetic neuropathy, neurocardiogenic syncope and fibromyalgia.

Product information

Brand names Contents Manufacturers FDA Approved
Brintellix Vortioxetine Takeda Pharmaceutical/H. Lundbeck A/S (Lundbeck) 30-Sep-13
Celexa Citalopram Forest Laboratories 17-Jul-98
Lexapro Escitalopram Forest Laboratories 14-Aug-02
Luvox Fluvoxamine Solva pharmaceutical 12-May-94
Paxil Paroxetine GlaxoSmithKline Feb-02
Prozac Fluoxetine Eli Lilly 29-Dec-87
Viibryd Vilazodone Actavis plc 21-Jan-11
Zoloft Sertraline Pfizer 30-Dec-91

It was noted when pregnant women consume SSRIs they increase the risk of autism spectrum disorder and birth defects in newborns

Major complications faced till date

  • Risk of Suicidal attempts and violent behavior in children, adolescents and young adults (Age group - 18 to 24)
  • Anencephaly, Cranisynostosis, Omphalocele
  • Autism spectrum disorder
  • Heart defects (septal), malformations
  • Persistent pulmonary hypertension of the newborn (PPHN)
  • Lung defects
  • Respiratory distress syndrome
  • Facial malformations like Cleft palate

Law suits of SSRI

FDA has issued alerts regarding unreported side effects of Zoloft, some of which have led to litigation. A number of lawsuits filed against Pfizer for birth defects.

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) and in 2006 about birth defects and autism to unborn child when used during pregnancy. The federal judicial panel moved federal Prozac cases to the U.S. district court for Southern district of Indiana in 1992. Thousands lawsuits filed against Eli Lilly as Prozac causing violence and birth defects.

In 2005 FDA reported warning alerts in regards to higher rate of heart-defects to babies of women used Paxil in early pregnancy. Thousands of lawsuits filed against GlaxoSmithKline for the serious injuries.

Allegations in Paxil lawsuits include:

  • Failure to warn about known dangers and failure to conduct clinical trial and Safety testing
  • Defective marketing
  • Birth defects - septal heart defects, pulmonary atresia, spina bifida, PPHN, cleft palate/lip, autism spectrum disorder

In August 2011 warning alerts were reported by FDA regarding dangerous effects of Celexa which includes birth defects and autism in child when used by pregnant mothers also it leads to abnormalities of heart like prolongation of QT interval, Torsade de Points and abnormal heart rhythms when used in more than 40 mg quantity per day. A judicial panel transferred federal Celexa suicide risk lawsuits to the U.S. District Court for the Eastern District of Missouri in 2006.

FDA added black-box warning to Forest Laboratories in 2004 regarding risk of suicidal thoughts and in 2006 alert warning was issued regarding birth defects when Lexapro used during pregnancy. It includes autism, birth defects like congenital heart defects, PPHN, cerebral palsy, erb's palsy. A judicial panel transferred federal Lexapro suicide risk lawsuits to the U.S. District Court for the Eastern District of Missouri in 2006.

Evidence to be looked for in potential cases

  • Usage of SSRI and other antidepressants in Pharmacy Records.
  • Duration of SSRI 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 SSRI intake
  • Treatment required for birth related defects in child.

Medical Record Review and claim validation of SSRI 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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