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.
Glaxo maintains it is not responsible for the heart defect diagnosed in Lyam, denies that it buried adverse event findings to maintain profits, and claims it properly tested Paxil, noted Bloomberg.com. Lyam’s mother, Michelle David, disagrees and alleges that the drug is responsible for her son’s heart defects, described by Bloomberg.com as “life-threatening.”
According to the U.S. Food & Drug Administration (FDA), in late 2005 it sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester, said Bloomberg.com, previously. Glaxo received reports of 50 miscarriages or intrauterine deaths by 1997, with its own scientists describing the amount of cases as an “alarming finding,” words omitted in the final report provided to the FDA, despite that it was mandated to include such information, reported Philly.com, citing the plaintiff attorney. Also, Bonnie Rossello, an executive at Glaxo, wrote in a 1997 memo that should animal studies be conducted, the drug maker could “bury” any negative findings, added Philly.com.
Regarding the woman who aborted her fetus over heart defects, it seems Glaxo was aware of the woman’s experience with Paxil in 2001 following her email to the drug maker looking for information concerning trials conducted on Paxil regarding birth defects, said Nieman, wrote Bloomberg.com. The woman wrote that while she was thrilled with Paxil’s benefits, “If there is a chance that this might hurt or affect the baby I want to know up front and I will somehow stop taking it for the time being,” said Nieman, quoting the email, reported Bloomberg.com. “… Please contact me as soon as possible. Please don’t forget about me,” the email went on to say.
Nieman said she was unclear who at Glaxo made the notation on it database, saying,” Somebody from GSK filled that in… There’s a possibility someone made a mistake and checked the box wrong.”
Kilker’s lawyers claim Glaxo built an advertising plan that included urging physicians to increase prescriptions written for expectant mothers suffering from anxiety, said Bloomberg. The family alleges Glaxo also hid Paxil’s birth defect links from the medical community.