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Lexapro Health Problems

Lexapro Health Problems

Lexapro (escitalopram) is in the SSRI, or Selective Serotonin Reuptake Inhibitors, class of antidepressants. Lexapro is manufactured and marketed by Forest Laboratories, Inc. as part of a partnership with Lundbeck, a European pharmaceutical firm. Lundbeck developed Lexapro in 1989 with approval to treat major depression. It is also used to for obsessive compulsive disorder (OCD) and social anxiety disorder. The patent for Lexapro expired in 2003, allowing generic versions of the drug to enter the market; however, Forest Laboratories, Inc. and Lundbeck had already created Lexapro (escitalopram) to replace Lexapro by that time.

Lexapro Side Effects

Lexapro side effects include a number of relatively minor side effects associated with many antidepressants such as nausea, insomnia, diarrhea, dry mouth, somnolence, dizziness and tremors. Additionally, antidepressants of the Selective Serotonin Reuptake Inhibitors (SSRI) class are also known to cause sexual dysfunction (Post SSRI Sexual Dysfunction) and problems when discontinuing use of the drug (SSRI Discontinuation Syndrome).

Lexapro Suicide Risks

Like many other antidepressants, Lexapro carries a "black box warning", one of the most severe FDA warnings, over an increased risk of suicide when used by persons under the age of 24. Certain groups of persons experienced much more severe Lexapro health problems than others. It was first noted that children under 18 were much more likely to become suicidal while taking Lexapro. In 2006 the FDA finally acknowledged the serious risk of suicide in young adults aged 18 – 24 that have taken these anti-depressants.   Even though individual FDA officials and even clinical studies by outside entities such as Columbia University confirmed that these anti-depressants almost doubled the rate of suicide in children, it was not until the FDA heard the testimony of parents directly impacted by suicides of their children that the agency took action, and then it was only a warning regarding the risk of deepening depression and possible suicide that appeared on the product label.

Lexapro Birth Defects

Some of the most severe side effects of Lexapro have been visited upon infants born to mothers who took Lexapro during pregnancy. Sertraline is known to stay in the body longer in women than men and analysis of the umbilical cord blood concentration indicates that fetal exposure (unborn child) to Lexapro is roughly one-third that of the mother. Lexapro birth defects have been particularly devastating when taken during the first trimester of pregnancy. Additionally, breastfeeding may expose infants to sertraline when taken by the mother.

Lexapro Maker Forced to Pay $150 Million Criminal Fine - Part of Overall $313 Department of Justice Celexa and Lexapro Settlement

In the fall of 2010, Forest Laboratories, Inc., the manufacturer of Celexa and Lexapro, entered into a number of agreements with government agencies including the Department of Justice and Department of Health & Human Services in an effort to extricate itself from criminal and regulatory violations. The settlement involved three drugs: Levothroid, Celexa and Lexapro. In the fall of 2010, Forest Laboratories, Inc., the manufacturer of Celexa and Lexapro, entered into a number of agreements with government agencies including the Department of Justice and Department of Health & Human Services in an effort to extricate itself from criminal and regulatory violations.  

The company plead guilty to one criminal felony count of obstructing justice, one misdemeanor count of distributing an unapproved drug (Levothroid) and one misdemeanor count of distributing a misbranded drug (Celexa), for which Forest Laboratories, Inc. agreed to pay a $150 million criminal fine as well as forfeit $14 million in assets and an additional $149 million to settle claims brought under the False Claims Act.  In addition to the $313 million settlement, Forest Laboratories, Inc. was required to enter into a 5-year Corporate Integrity Agreement with the Department of Health & Human Services, Office of the Inspector General.   Carmen Ortiz, US Attorney for the District of Massachusetts, observed that the criminal and civil cases against Forest Laboratories, Inc. demonstrated that the company placed "a higher priority on increasing corporate sales than on complying with the basic legal requirements that Congress and the FDA created."