The prescription medication Lexapro (escitalopram) has a disturbing history, even compared to other dangerous drugs. Lexapro, which is designed and sold by the pharmaceutical company Forest Laboratories, is an antidepressant that works as a selective serotonin reuptake inhibitor (SSRI).
From a chemical standpoint, Lexapro is virtually identical to the drug citalopram, which was sold under the brand name Celexa. The two drugs are stereoisomers, which means they have the same molecules, joined together in the same order, but they are mirror images of one another. Because of that chemical similarity, many scientists have accused Forest Laboratories of “evergreening,” the term used when a pharmaceutical company makes a trivial modification to an existing drug in order to extend the length of patent protection for the medicine.
It is illegal for drug companies to market drugs for purposes that were not approved by the Food and Drug Administration (the practice is called “off-label marketing“). Since its approval by the FDA for the treatment of depression and generalized anxiety disorder in adults, however, Forest Laboratories has allegedly engaged in aggressive “off-label” marketing of the drug for use in children and teenagers. The practice was so widespread that a federal whistleblower lawsuit was filed alleging the company “used illegal kickbacks to induce physicians and others to prescribe Celexa and Lexapro,” including “cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment.” The Department of Justice joined the case (which also alleged illegal marketing by Forest Pharmaceuticals of other drugs), and the company settled the case for $313 million in September 2010.
Most tragically, however, Lexapro has been prescribed to many women in their child-bearing years even though it has been shown to increase the risk of multiple serious birth defects, including aorta coarctation, heart defects, omphalocele, persistent pulmonary hypertension of the newborn (PPHN), and spina bifida. Unfortunately, as confirmed by many studies including a 2007 student in the Annals of Internal Medicine in 2007, “over the course of a year, one in six women of reproductive age filled a prescription for a medication labeled by the Food and Drug Administration as increasing the risk of fetal abnormalities” because the women had not been adequately warned of the risks of birth defects.
Parents across the country have begun filing lawsuits against Forest Laboratories for the company’s failure to properly test Lexapro for the risks of birth defects, for failing to monitor “adverse event reports” that came in on Lexapro suggesting a high prevalence of birth defects, for failing to follow FDA guidelines on evaluating the risk of drug exposure in pregnancy, and for failing to adequately warn patients and their doctors of the risks of severe birth defects.
If you took Lexapro during your pregnancy and your child developed birth defects, contact us for a free, confidential consultation by calling my office at (215) 948-2718 or using the contact form below. We don’t charge to review your medical records to see if your child may qualify for compensation for Forest Laboratories’ negligence, and contacting us doesn’t obligate you to use us as your attorneys.