GlaxoSmithKline told to pay family $2.5m after jury finds paroxetine caused son’s heart defectsBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b4266 (Published 15 October 2009) Cite this as: BMJ 2009;339:b4266
A Philadelphia jury has found that the antidepressant paroxetine (marketed as Paxil in the United States and Seroxat in the United Kingdom) caused heart defects in a child, Lyam Kilker, whose mother Michelle David took the drug while pregnant. The jury has awarded the family $2.5m (£1.5m; €1.7m) in compensation.
The trial was the first of about 600 US lawsuits that claim that paroxetine caused birth defects in infants born to mothers who took the drug while pregnant (BMJ 2009;339:b3967, doi:10.1136/bmj.b3967).
GlaxoSmithKline, the drug manufacturer, which is based in London, said in a statement that it “disagrees with the verdict and will appeal.” The company said that although it sympathises with the child and his family, “the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition. Very unfortunately, birth defects occur in three to five per cent of all live births, whether or not the mother was taking medication during pregnancy.”
The company said that it had “acted properly and responsibly” in clinical trials with paroxetine and shared documentation and study results with regulators. It also said that it had acted properly in marketing the medicine “including monitoring its safety, updating pregnancy information in the medicine’s labelling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community, and the public.”
The jury found that GlaxoSmithKline officials had “negligently failed to warn” the doctor treating Lyam’s mother about paroxetine’s risks and concluded that the drug was a “factual cause” of the child’s heart defects, according to a report by the Bloomberg news service (www.bloomberg.com, 13 Oct, “Glaxo ordered to pay $2.5 million for paxil defect”).
Lyam is almost 4 years old and has had heart surgery several times.
Paroxetine, a selective serotonin reuptake inhibitor, was approved by the Food and Drug Administration for use in the United States in 1992. It had sales of $942m in the US last year, according to the Philadelphia Inquirer (www.philly.com, 13 Oct, “Glaxo must pay $2.5m in Paxil case”).
In December 2005 the FDA changed its labelling on paroxetine to warn that the drug might not be safe to use in pregnancy, while stating that the benefits of continuing use by some women who were already taking it might be greater than the potential risk to the fetus.
Cite this as: BMJ 2009;339:b4266