In October 2009, a jury in Philadelphia awarded $2.5 million to the family of a young boy who was born with severe heart defects caused by his mother’s use of Paxil during pregnancy. During the trial, jurors in the case heard evidence that drugmaker GlaxoSmithKline (GSK) knew of evidence linking Paxil and birth defects, but failed to adequately warn about the side effects of the drug or recall it from the market.
Following this verdict, GSK agreed to pay more than $1 billion in July 2010 to settle more than 800 Paxil lawsuits that had been filed by the families of children born with heart defects or other birth defects. In spite of the settlement, it was reported that about 200 additional lawsuits over Paxil birth defects remained pending against the company.
At the time of the July 2010 Paxil settlement, GSK had already paid more than $1 billion to settle previous lawsuits filed over the antidepressant. In addition to cases involving children born with birth defects, these lawsuits included allegations that Paxil could increase the patient’s suicide risk or that taking Paxil could cause addiction or lead to severe withdrawal symptoms.
The Food and Drug Administration has issued multiple Paxil warnings about the side effects risk associated with the drug. In 2005, the agency warned that women who take Paxil during the first trimester of pregnancy are twice as likely to give birth to a baby with birth defects. The most commonly reported problems in these cases were atrial septal defects (ASD) and ventral septal defects (VSD). The agency also warned in 2006 that children born to women who took antidepressants such as Paxil while pregnant were six times more likely to develop persistent pulmonary hypertension of the newborn (PPHN), a serious and potentially fatal circulatory condition.
Despite these lawsuits and multiple warnings from the FDA about the risk of birth defects and other Paxil side effects, GSK has not announced plans to issued a recall on Paxil in the U.S. There are still currently about 200 Paxil birth defects lawsuits pending against the company.