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GlaxoSmithKline (GSK): We Conducted Paxil Clinical Trial Program Appropriately


12/7/2012 8:52:23 AM

Pharmaceutical giant GlaxoSmithKline says it conducted its clinical trial program for the anti-depressant drug Paxil appropriately in marketing the medicine for use by women of childbearing age. The statement comes after a B.C. Supreme Court judge certified a class-action lawsuit launched by a British Columbia mother whose daughter was born with a hole in her heart. Lawyers allege the drug caused birth defects when taken during pregnancy, and say the company didn't properly warn doctors about the risks. In a statement, spokeswoman Michelle Smolenaars Hunter says the company acted appropriately in its clinical trials, marketing, safety monitoring and updated pregnancy information as new information became available. Faith Gibson's daughter Meah Bartram was born just two weeks before the company warned doctors that taking the drug during pregnancy could increase the chance of cardiovascular defects. One of her lawyers, David Klein, argues the company ought to have know the risks before then, and is pointing to small-scale studies and studies on similar products that were already available to the scientific community. But Smolenaars Hunter says the company acted responsibly.

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