Paxil and PPHN - Consumer Justice Foundation

Paxil and PPHN

Written by Faith Anderson on April 3, 2012
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Paxil and PPHN Birth Defects

SSRIs like Paxil are a class of antidepressant medications that act upon the neurotransmitter serotonin in the brain to relieve depression and improve certain mood disorders. Paxil garnered FDA approval in 1992 as a treatment for major depressive disorder, and was additionally indicated in later years to treat conditions like obsessive-compulsive disorder, social anxiety disorder and major panic disorder. Despite its popularity in treating depression and other debilitating conditions, Paxil maker GlaxoSmithKline has received significant criticism in recent years because of its possible connection to major birth defects like PPHN. PPHN, or persistent pulmonary hypertension of the newborn, is a potentially fatal birth defect in which a baby’s circulation continues to bypass the lungs after birth, depriving the rest of the body of the oxygen it needs to survive.

FDA Warnings for Paxil Birth Defects

The latest Paxil birth defect study follows a warning issued by the FDA in 2005 regarding the link between Paxil use in pregnancy and congenital malformations, including heart defects. It was this FDA notice that elevated the pregnancy category of Paxil from C to D. In 2006, the FDA issued an additional public health advisory warning consumers and healthcare professionals that babies exposed to SSRI drugs like Paxil after the 20th week of pregnancy may be six times more likely to suffer from PPHN than babies exposed to no antidepressants in pregnancy. According to the BMJ study, conducted by researchers in Sweden, babies whose mothers take an SSRI like Paxil during pregnancy are twice as likely to be born with the life-threatening birth defect, PPHN.

Posted Under: United States
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