A woman in Brampton, Canada—29-year-old Shannon Cote—has alleged that 10-year-old son’s health problems are directly related to the antidepressant Paxil (Paroxetine) that was prescribed to her during pregnancy. She is now pursuing legal action against the drug manufacturer, GlaxoSmithKline.
Although GlaxoSmithKline claims it has not received formal notification of any legal action with respect to this matter, it issued the following statement: “Paroxetine has been used by tens of millions of patients and, when used appropriately, has been proven to be a safe and effective treatment since its launch more than 15 years ago. The label contains instructions regarding the use of paroxetine and important safety information about the product. If patients have questions regarding the use of paroxetine, or the management of their depression, they should contact their health-care professional. Also, it is very important that patients do not stop taking paroxetine without first consulting with their doctor.”
Cote’s lawyers state that she became pregnant in August 1997 at around the same time that she began to suffer from low self-esteem and depression. Cote claims that her family physician prescribed Paxil and was also assured at the time that Paxil, unlike other antidepressants, was suitable for use by pregnant women. Despite this, Cote’s son was born with heart defects that her lawyers claim are directly linked to her Paxil use. They also charge that GlaxoSmithKline failed to ensure that a proper warning was placed on Paxil’s prescription label and that Paxil’s packaging did not contain proper usage instructions. According to Cote’s attorneys, “Birth defects were caused solely as a result of the negligence of the defendant manufacturer. As a result of (the child’s) heart defects, the plaintiffs have been forced to live with severe psychological problems that have affected their daily lives …. The manufacturer was aware that knowledge must be provided to patients as to the possible side effects of the drug but ignored all of these matters.”
A warning about Paxil’s effects on pregnant women has since been put on the bottle after U.S. Food and Drug Administration (FDA) studies revealed a link between Paxil use during pregnancy and birth defects in newborn children, an issue on which we have long been reporting.
The FDA strengthened its warning for Paxil because it may be associated with birth defects, citing a new study that found increased risk of fetuses developing such heart defects. The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name Paroxetine, as a “Category D” drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. Two studies of pregnant women taking Paxil during their first trimester showed that their babies have heart defects at a rate of 1.5 to 2 times the norm. The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or to people who are planning to become pregnant, unless there are no other options.
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