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GlaxoSmithKline sued over prenatal Paxil use, birth defects

A lawsuit was filed against pharmaceutical co. GlaxoSmithKline on July 28, on behalf of two-year-old Adrian Vasquez of Bedford, Texas, who was born on April 19, 2004 with birth defects.

The suit alleges that Adrian's birth defects are the result of his mother's prenatal use of Paxil, a GlaxoSmithKline antidepressant drug in the SSRI class (selective serotonin re-uptake inhibitor).

The FDA recently upped the Paxil warning from a category "C" to a category "D," warning pregnant mothers that taking Paxil more than doubles the risk of a heart defect in newborn babies. As the FDA officially puts it, "Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus."

As always on this issue, we're left pretty much where we started. Some antidepressants during pregnancy = potentially bad for baby. Untreated depression during pregnancy = definitely bad for baby (with plenty of research data to back it up). As always, defer to an individual risk-benefit analysis suited to your history and your needs, in private consultation with your healthcare provider. And if you are a woman who is not convinced that your healthcare provider is up to date on the latest research in this area, or if the provider blows off your concerns or won't sit down for a sustained conversation, get a new doctor, pronto!

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