Understanding Paxil Birth Defects

In December 2005, GlaxoSmithKline (GSK) posted its Paxil findings on its
website regarding pregnant women taking antidepressants. In this announcement,
GSK noted that it was revising its pregnancy precaution category from C to D.
This revision was based on recent studies that indicated positive evidence of
human fetal risk. In addition, GSK was placing this information in the WARNINGS
section of the Paxil label.

The FDA then advised pregnant women to switch from Paxil to another SSRI
drug, such as Prozac or Zoloft. This warning was based on the results of an
analysis of Sweden’s birth registry that showed women who took Paxil were 1.5 to

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PAXIL: BIRTH DEFECTS – TEST CASE FOR OVER 600 MORE CASES – USA

GlaxoSmithKline P.L.C., the world’s second-biggest drugmaker, begins a trial in Philadelphia next week in what may be a test case for more than 600 lawsuits over claims that the company’s antidepressant drug Paxil causes birth defects.

Patients and their parents say internal company documents show Glaxo failed to warn consumers about the risks of Paxil until forced to do so in 2005 by the Food and Drug Administration. In the trial set to start Monday, Michelle David blames the drug for causing life-threatening heart defects in her son, Lyam Kilker, now age 3.

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