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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 FDA on 27 November 2002 in solution form and on 14th August 2012 in tablet form. The drug is used for treating adults and children above 12 years of age with 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 of the brain. It blocks the reabsorption or reuptake of neurotransmitter serotonin in brain. The drug was initially approved by 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 USA. Recent studies showed link of this drug with serious birth defects such as autism, spina bifida, neural defects, etc. in new born babies. Many lawsuits were filed against Lexapro. The drug's patent expired in 2012 and the first generic version of Lexapro was approved in market in March 2012 by FDA.
Cipralex is the other brand name containing Escitalopram manufactured by Lundbeck.
Major complications faced till date:
Some of the major injuries that have been reported by after initiation of Lexapro includes:
- 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
- Cleft lip/palate
- Limb defects
- Cranial defects
- Neural tube defects
- Other congenital birth defects
- Worsening depression
- Suicidal tendencies
Law suit allegations against Lexapro:
In June 2005, FDA released a public health advisory proclaiming that recent scientific publications indicated the increased risk for suicidal behaviors in adults who are being treated with Lexapro. FDA stressed that adults who are taking antidepressants such as Lexapro should be closely watched for worsening depression and increased suicidal tendencies.
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 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 child bearing 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.
The lawsuits filed in St. Louis Circuit Court accuse that the companies promoted the drug to expectant mothers and women of childbearing age in spite of the fact that they knew about the increased risks of birth defects. Recently, the lawsuits regarding suicides and suicidal attempts caused by use of Lexapro had been consolidated into multidistrict litigation in the U.S. District Court for Eastern District of Missouri for pretrial proceedings. These pretrial proceedings were completed in 2013 and the court has sent pending lawsuits back to original federal courts where these had been filed for trial.
Evidence to be looked for in potential cases
- 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.