GSK - Paxil: “I don’t know who made that assessment, but it’s there,”

A former GlaxoSmithKline executive has testified that officials with the drug maker said in 2001 that a birth defect in a fetus was probably linked to the mother’s use of Paxil, reported Bloomberg.com. Glaxo is facing some 600 pending cases in which Glaxo is alleged to have known Paxil causes birth defects, yet hid those findings.

The former Glaxo official stated, under oath during a Philadelphia state court trial, that the birth defect was revealed in the unborn baby of a woman taking Paxil when pregnant, said Bloomberg.com. That particular adverse event took place in 2001. Officials with the drug giant apparently indicated in Glaxo’s files that, after reviewing an email received from the woman who aborted her fetus because of a heart defect, it was “almost certain” Paxil was associated with the defect, said Bloomberg.com, citing Jane Nieman. Nieman is a former drug safety executive with Glaxo, said Bloomberg.com.

According to Nieman’s testimony, “I don’t know who made that assessment, but it’s there,” quoted Bloomberg.com. The testimony was videotaped from her deposition and played for jurors in a case involving another family in which a three-year-old boy—Lyam Kilker—allegedly suffered birth defects due to his mother’s Paxil use, reported Bloomberg.com. According to Philly.com last week, the plaintiff’s attorney claimed Glaxo ignored information that the antidepressant caused birth defects. The boy has undergone some cardiac surgeries and is expected to have to undergo at least one more operation.

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