Paxil and Heart Defects - Consumer Justice Foundation

Paxil and Heart Defects

Written by Faith Anderson on February 6, 2012
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FDA Warnings Issued for Paxil Birth Defects

Paxil (paroxetine) was originally approved by the FDA in 1992 as a treatment for major depressive disorder. Since that time, Paxil has been additionally indicated to treat obsessive-compulsive disorder, post-traumatic stress disorder, major panic disorder, social anxiety disorder and generalized anxiety disorder. Paxil is considered an SSRI (selective serotonin reuptake inhibitor) antidepressant, and is currently manufactured by pharmaceutical company, GlaxoSmithKline.

The potential link between Paxil and major birth defects has been apparent for several years. In 2005, the FDA issued a public health advisory informing the public that exposure to Paxil during the first trimester of pregnancy may increase a baby’s risk for congenital malformations, particularly heart defects. In 2006, the FDA issued an additional public health advisory regarding the potential side effects of SSRI antidepressants like Paxil. According to the agency, women who use SSRIs like Paxil while pregnant may have an increased risk of giving birth to children with a life-threatening lung and heart defect called persistent pulmonary hypertension of the newborn (PPHN).

Studies Warning of Possible Paxil Birth Defects

The FDA warnings regarding potential Paxil heart defects were influenced by several different studies indicating a possible link between Paxil and cardiac malformations. The 2005 public health advisory issued by the FDA was based on the results of two unpublished epidemiological studies. According to one study using Swedish national registry data, women who were treated with Paxil in early pregnancy had an approximately two-fold increased risk for having a baby with a heart defect, compared to the entire national registry population.

The second study used information from a United States insurance claims database, and discovered that children born to women who used Paxil in the first trimester had a 1.5-fold increased risk for heart defects and a 1.8-fold increased risk for birth defects overall, compared to babies born to women who took other antidepressants while pregnant. The 2006 FDA warning was based on a New England Journal of Medicine study published that same year, in which researchers found a shocking six-times increased risk of PPHN in children exposed to SSRIs like Paxil after the twentieth week of pregnancy, compared to unexposed children.

Posted Under: FDA - Food and Drug Administration
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