Glaxo Facing Legal Challenges Over Paxil’s Connection to Birth Defects

A new group of lawsuits is claiming that the use of Paxil during pregnancy is responsible for children being born with significant birth defects. Studies have linked the prescription antidepressant with cardiovascular defects and congenital malformations in the brain, heart, lungs, and other vital organs. At this point, five personal-injury and product-liability actions have been taken against GlaxoSmithKline on behalf of Paxil patients who have given birth to infants with serious heart defects.

The most recent suit was filed in Pennsylvania–GSK’s offices are in Philadelphia–on behalf of Denver resident Lisa Boden, whose child was born with persistent pulmonary hypertension, a severe lung condition in which blood flow to the lungs is constricted. The suit was filed by Baum Hedlund, who also filed a suit in July on behalf of Texas residents Anthony and Matilda Vasquez, whose son Adrian was born with severe congenital heart defects.

Paxil, or paroxetine, was first approved for use by the FDA in 1993, and despite growing concerns over its side effects and dangers, it has become one of the world’s most popular prescription drugs. Numerous studies over the past decade have raised the possibility that taking Paxil during pregnancies may lead to <"">birth defects, physical abnormalities, neonatal complications, respiratory ailments, and other problems. In December of 2005, the FDA changed the drug’s classification to Category D, which means that observational or controlled studies of pregnant women have shown that consumption of the drug during pregnancy is a risk to the fetus.

Only three months before, the FDA forced GSK to change the Paxil label in order to include the “results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants…”

In February of this year, a study published in the New England Journal of Medicine claimed that women taking SSRI-type antidepressants during the second half of pregnancy were six times as likely to give birth to children with persistent pulmonary hypertension. This study was countered by an industry-based study in support of the drug, which warned in the Journal of the American Medical Association that pregnant women who stopped taking SSRIs suffered a significant risk of relapse into depression.

Before the recent spate of lawsuits related to birth defects, Paxil had come under legal fire related to severe withdrawal symptoms that include self-damaging or suicidal tendencies.

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