Paxil and birth defects
Studies indicate children born to women who use Paxil during the first trimester of pregnancy are at increased risk of birth defects
Paxil (paroxetine) is an anti-depressant manufactured by GlaxoSmithKline. In 2005 the FDA issued a Public Health Advisory for Paxil based on recent studies that showed an increase risk of birth defects in children born to mothers exposed to Paxil in the first trimester.
According to an FDA MedWatch Alert, the study shows an increased risk of overall major congenital malformations for paroxetine in particular, as compared to other antidepressants.
These findings are a result of a retrospective epidemiologic study of 3,581 pregnant women, conducted by GSK, which examined major congenital malformations in infants born to women taking antidepressants in the first trimester of pregnancy.
The study revealed a greater risk for overall major congenital malformations for women using paroxetine compared to other antidepressants, as well as an increased risk for cardiovascular malformation using paroxetine as compared to other antidepressants. Ten out of 14 infants with cardiovascular malformations had ventricular septal defects.
In July 2006, the FDA released another Public Health Advisory for Paxil, based on results of another study that indicated additional risks associated with taking antidepressants during pregnancy.
This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.
According to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI-antidepressant were more likely than those who were not exposed to have an infant with birth defects.
Birth defects also include omphalocele (an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel) or craniosynostosis (connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull).
Paxil is used for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder. Paxil CR is used in the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder.
Patients taking Paxil or Paxil CR should contact their physician before stopping use of any prescribed medication.
Do you have a Paxil claim?
If you or a loved one has a child born with paxil birth defects, you may have a claim against the drug manufacturer.