• Lexapro Medical Record Review & Outsourcing Services

Lexapro (Escitalopram) was introduced and marketed by U.S-based Forest Laboratories Inc., in partnership with the Danish drug company Lundbeck. The drug was approved by the FDA on November 27, 2002, in a solution form and on August 14, 2012, in a tablet form. The drug is used for treating adults and children above 12 years of age with the major depressive disorder and generalized anxiety disorder. It is available in tablets and oral forms. Lexapro is a selective serotonin reuptake inhibitor (SSRI) administered orally.

Lexapro works by restoring the chemical balance in the brain by increasing the serotonin levels in the brain. It blocks the reabsorption or reuptake of neurotransmitter serotonin in the brain. The drug was initially approved by the FDA for treating only adults, but later it was approved to treat depression in adolescents aged 12 and above.

It was aggressively marketed and became the most popular antidepressant in the USA. Recent studies linked the drug with serious birth defects, such as autism, spina bifida, neural defects, etc. in newborn babies. Many lawsuits were filed against Lexapro. The drug's patent expired in 2012 and the first generic version of Lexapro was approved in the market in March 2012 by the FDA.

Cipralex is the other brand name containing Escitalopram manufactured by Lundbeck.

Serious Alleged Injuries may include:

  • New born children born with autism
  • Children born with spina bifida
  • Persistent pulmonary hypertension of the newborn
  • Ventricular outflow defect, septal defects, congenital heart lesions & anomalies
  • Down's syndrome
  • Undescended testes in males
  • Clubfoot
  • Cleft lip/palate
  • Limb defects
  • Cranial defects
  • Neural tube defects
  • Other congenital birth defects
  • Worsening depression
  • Suicidal tendencies

FDA Safety Warnings:

  • In 2004, the FDA added a black box warning to Lexapro to alert patients to the increased risk of suicidal thoughts and behaviors, especially in patients younger than 25. (An increased risk of suicide is a common severe side effect of SSRI antidepressants.)

Important Events:

  • In 2009, the U.S. Department of Justice alleged Forest labs of faulty marketing practices that included unapproved uses, not disclosing the potential negative study results of clinical trials and paying illegally to doctors who prescribed the drug.
  • In 2012, women who filed lawsuits against Lexapro claimed that the company promoted the drug being safe for pregnant women and other women of childbearing age.
  • In 2015, a study published in JAMA Pediatrics associated Lexapro and other SSRIs which were taken during pregnancy to a 200 percent increase in the rate of autism.

Legal Updates:

In 2009, MDL No 2067: In Re: Celexa and Lexapro Marketing and Sales Practices Litigation was established in the U.S. District Court for Massachusetts under U.S. District Court Judge Nathaniel M. Gorton.  The drugmaker was accused of misleading Missouri parents into buying Celexa and Lexapro for children although the drugs were only approved for adults.

In March 2014, Forest Labs agreed to pay $10.4 million to settle an MDL accusing Forest Labs of misleading parents into buying Lexapro and Celexa for their children.


  • Indication of Lexapro usage in Medical Records.
  • Pharmacy records indicating usage of Lexapro
  • Images of Lexapro pills
  • Follow-up complications and their treatment after initiation of Lexapro pills both in adults and adolescents above 12 years in medical records

Medical Record Review and claim validation of Lexapro case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.



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