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Major depressive disorder affects approximately 14.8 million American adults or about 6.7 percent of the United States population, age 18 and older (Archives of General Psychiatry, 2005 June; 62(6): 617-27).  It’s not surprising that pharmaceutical antidepressants have become such a big business.  Unfortunately, all synthetic medications come with side effects.  Prozac, Paxil, Lexapro and Zoloft are Serotonin reuptake inhibitors (SSRIs), which increase the extracellular level of the neurotransmitter serotonin, which can alter a person’s mood.

Lexapro was first introduced by Forest Laboratories in 2002, with generic versions approved in 2012, when the drug’s patent expired.  The drug received a black-box warning from the FDA regarding the increased risk of suicidal thoughts and behaviors in patients younger than 25 in 2004.  In 2006, Lexapro was given a grade C by the Food and Drug Administration for its level of safety when used during pregnancy.  Even so, the benefits of the drug sometimes outweigh the risks for some expectant mothers, therefore its use continues to gain approval.   In June of 2013, Lexapro (Escitalopram – generic version) was added to the MedWatch Adverse Event Reporting program of the Food and Drug Administration.

Dangers to an unborn fetus, however, have led to birth defects including Persistent Pulmonary Hypertension of Newborns (PPHN), Cleft Palette and/or Cleft Lip, heart defects, neural tube defects, limb defects, spina bifida and cranial defects.  Lawsuits stemming from the use of Lexapro allege a lack of warning about the dangers of the medication.  In 2010, Forest Laboratories was ordered to pay more than $300 million for illegally marketing Lexapro, as well as two other drugs.  The lawsuits are filed in two multidistrict litigation lawsuits in federal court in Massachusetts and Missouri.  Other lawsuits have been filed separate from the federal mass tort litigation for both increased risks of suicide and birth defects occurring after taking the drug during pregnancy.

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