Case Study: Forest Laboratories

Introduction and General Purpose
Lexapro (Escitalopram) is an antidepressant that is classified under a group of drugs called Selective Serotonin Reuptake Inhibitors. It was approved by the Food and Drug Administration in the United States on August 2002 (Expert Reviews Ltd, 2003). Lexapro is used to treat adults and adolescents 12 to 17 years of age who have been diagnosed with Major Depressive Disorder. It has also been approved to treat adults suffering from Generalized Anxiety Disorder (Brown University Child & Adolescent Psychopharmacology Update, 2012). It works by blocking the reuptake of the neurotransmitter of the brain called serotonin, which regulates mood, and restores the brain’s chemical balance by increasing its levels (Mayo
The complaint accused Forest Laboratories of violating laws under the False Claims Act stating that personnel of Forest Laboratories improperly promoted Lexapro for off-label pediatric use. Forest Laboratories was accused of paying physicians to encourage them to prescribe Lexapro and other drugs created by them. Additionally, Forest Laboratories was accused of blocking negative publications of one of their trials and reports that individuals suffered from increased suicidal ideations. The lawsuit was eventually settled in 2010 for the sum of 149 million (Carandang, MacBride,
From October 2005 to September 2010 approximately 127 million prescriptions of Lexapro were dispensed from retail pharmacies within the United States. About 3.9 million prescriptions dispensed were for the pediatric populations, ages 0 to 17, which equates to 3% of the total reported prescriptions dispensed. Within the pediatric category, 24,000 prescriptions were dispensed for children of ages 0 to 5, 862,000 for ages 6 to 12 and 3 million for ages 13 to 17. The most common diagnosis reported for use of Lexapro were “Anxiety Status” for children under 5, “Depressive Disorder Not Elsewhere Classified” for patients of ages 6 to 17 and adults over the age of 18. During this period, it was reported that family medicine practitioners and doctor of Osteopathy were the primary prescribers of Lexapro, prescribing approximately 32% of all prescribed medications. Psychiatry doctors were found to prescribe 21% and Pediatricians 1.3% of the total prescriptions dispensed (Mehta,