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Feb 21 2012

Lexapro Side Effects May Include Persistent Pulmonary Hypertension In The Newborn (PPHN)

Posted in Community Service, Product Liability

Lexapro a highly effective drug used in the medical treatment of depression, may cause birth defects in pregnant women, says Alabama liability attorney Keith T. Belt


A recently released study suggests newborns could be at risk of Lexapro side effects, including serious Lexapro birth defects. The study, which found that infants exposed to selective serotonin reuptake inhibitors (SSRIs) prior to birth had an increased risk of persistent pulmonary hypertension, was published in the British Medical Journal. Meanwhile, Forest Laboratories Inc., maker of Lexapro, faces allegations that it paid a researcher to fix study results.
The whistleblower complaint, unsealed January 20 and reported by Bloomberg BNA (02/01/12), alleges Forest Pharmaceuticals paid a principal researcher involved in a study of Celexa, another SSRI antidepressant. Lexapro is a second generation of Celexa. According to the whistleblower, the alleged violations of the False Claims Act occurred during the STAR*D (Sequenced Treatment to Relieve Depression) study, which received funding from the National Institute of Mental Health.

The allegations were made by H. Edmund Pigott, who claims that bias in the STAR*D trial favored Celexa, and that bias was allegedly the result of kickbacks and bribes. Furthermore, he alleged, as a result of those bribes, researchers overstated the effectiveness of Celexa, leading to an increase in sales of both Celexa and Lexapro. The STAR*D trial was designed to study the effectiveness of different treatments for people with major depression, but included Celexa, even though Celexa was the least prescribed SSRI antidepressant.

While researchers allege wrongdoing on the part of a drug company, a different study, published in January in the British Medical Journal suggests that infants exposed to SSRI antidepressants are at increased risk of persistent pulmonary hypertension of the newborn (PPHN), a potentially fatal respiratory disorder. In fact, researchers found the risk of PPHN was almost double that of the risk faced by infants who were not exposed to SSRI antidepressants prior to birth.

The study involved an analysis of the birth registry data from babies born between 1996 and 2007 in Sweden, Iceland, Denmark, Finland and Norway. According to WebMD (01/12/12), researchers also found that mothers who were hospitalized for a psychiatric disorder but were not using SSRIs during pregnancy also had an increased risk of delivering a baby with PPHN.

Babies born with PPHN do not adapt to breathing outside the womb and may suffer from a lack of oxygen circulating through their blood flow. This can cause organ failure and death. Babies who survive PPHN sometimes require multiple surgeries and extended hospital stays.