Jury Sides with Family in Paxil Birth Defect Case.
GlaxoSmithKline lost its first battle to prove that its antidepressant Paxil led to birth defects. The company will have to pay $2.5 million in damages to the family of Lyam Kilker. It is a small drop in the bucket for a giant pharma company like GSK, but it’s scary when you come to 600 more cases on the docket.

GSK is being ordered to pay $2.5 million in restitution to this Pennsylvania family. The firm was accused of not doing enough to warn consumers that taking the antidepressant Paxil (Paroxetine, Generic Paxil), while pregnant, could lead to birth defects.

GSK insisted that it carried out the appropriate Paxil clinical trials before approval and that FDA regulators were aware of all side effects of Paxil. It also updated the warning label to include new information about pregnancy risk and properly monitored the treatment after it was released to the public.

GSK denies all of these allegations and said that it will appeal the decision.

Paroxetine (trade names Seroxat, Paxil) is a selective serotonin reuptake inhibitor antidepressant. Marketing of the Paxil began in 1992 by SmithKline Beecham, now GlaxoSmithKline. Paroxetine is used to treat major depression, obsessive-compulsive, panic, social anxiety, and generalised anxiety[1] disorders in adult outpatients.

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3. Drugs for depression, anxiety tied to preterm birth – Reuters