Paxil Birth Defects: Two Women, One Cause

Brampton, ONTwo women, both taking the selective serotonin reuptake inhibitor (SSRI) Paxil while pregnant, have launched independent lawsuits against GlaxoSmithKline (GSK) , alleging the pharmaceutical company failed to adequately warn them of the risks of taking the drug while pregnant.

The most recent case is that of Shannon Cote, a 29-year mother, whose son was born 10 years ago with heart defects that her lawyers argue are directly related to her use of Paxil while pregnant.

Shannon became pregnant in 1997, at a time when she was suffering from depression and low self esteem. So her health care professional prescribed the SSRI for her and assured her that unlike other antidepressants it was fine to take during pregnancy. However, as it later became known, Paxil was and is not safe to take during pregnancy. And the Food and Drug Administration (FDA) noted that in the new labeling for the drug in December 2005, several years too late for Shannon and her son.

Another case is that of a young woman who gave birth to a baby girl in September 2005, just 4 months before the FDA warning was issued. Faith's daughter, Meah, was born with a hole in her heart. Like Shannon, Faith was told that she would be fine taking Paxil while pregnant. In fact it was approved for the treatment of anxiety even in pregnant women.

Faith had no reason to doubt this information, she had been taking the antidepressant since 2002. In fact, she didn't doubt the information until she read an article in the local paper about another woman in a similar situation who was suing GSK alleging the drug maker was aware of Paxil side effects that could result in birth defects. That's when Faith had her "Ah Ha" moment: she realized that Meah's heart defect was likely not 'the luck of the draw' but rather a Paxil birth defect.

Paxil Birth Defects – What About the Moms?

Both Shannon and Faith suffer as a result of the Paxil birth defects their children have. Shannon suffers from severe psychological problems that have affected her everyday life, and that's in addition to the medical and financial realities of caring for a child with a defective heart.

And Faith, after enduring 7 months of hospital visits to her baby, continues to worry about her daughter's health. "My daughter has a huge, awful scar down her chest that will grow with her," she said. And, Meah is smaller than other children her age. "She's little, and if there's a cold or anything going around she gets it and she suffers far more."

Did GSK Know?

The fundamental fact that both women no doubt wrestle with is that these birth defects were preventable. And that is why they are suing GSK. The FDA warning issued in December 2005 mentioned an increased risk for serious heart defects associated with the use of Paxil in pregnant women.

The warning was based on data from 2 studies which showed a 1.5 to 2 times increased risk of giving birth to a child with a heart defect compared with pregnant women not taking the anti-depressant. In addition to the warning, the FDA actually placed Paxil in its second highest category for risk of birth defects, advising patients that "this drug should usually not be taken during pregnancy."
In a later warning, the FDA said that Paxil "should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future."

It is highly likely that GSK had some indication that there could be problems with Paxil during pregnancy prior to the FDA warnings, and that is what the attorney's for Shannon and Faith hope to establish.

If you have had a baby born with abnormalities which could be related to the use of Paxil or another SSRI, consider contacting a lawyer.