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Friday, September 18, 2009

Glaxo Linked Birth Defect of Fetus to Paxil, Ex-Executive Says



"After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury."



By Jef Feeley and Sophia Pearson

Officials of GlaxoSmithKline Plc, the U.K.’s largest drugmaker, said in 2001 that a birth defect in the fetus of a woman taking its Paxil antidepressant likely was linked to the drug, according to court testimony.

After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury.

“I don’t know who made that assessment, but it’s there,” Nieman testified in a videotaped deposition played yesterday for jurors. Nieman’s testimony came in the trial of another Paxil user’s lawsuit over birth defects suffered by her now 3-year-old son.

The state-court trial in Philadelphia is the first of more than 600 cases alleging Glaxo knew Paxil caused birth defects and hid those risks to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Lyam’s mother, Michelle David, blames Paxil for causing her son’s life-threatening heart defects.

Safety Information

Glaxo’s lawyers contend the London-based drugmaker isn’t liable for Lyam’s heart defects and acted responsibly in testing Paxil and updating safety information.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“It would be inappropriate to comment on evidence during the middle of a trial,” Kevin Colgan, a Glaxo spokesman, said in an e-mail.

Glaxo officials learned about the woman’s experience with Paxil in 2001 after she e-mailed the company seeking information on studies done about Paxil’s links to birth defects, said Nieman, who was the company’s director for evaluation and training for global clinical safety at the time.

The woman, whose identity was withheld by Glaxo, said she’d been taking Paxil for anxiety when she found out she was pregnant, Neiman said. The woman praised Paxil as a “miracle drug” that provided relief from panic attacks, the executive added.

‘Made A Mistake’

“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,” the woman said in the e-mail. “I love everything this drug has done for me. Please contact me as soon as possible. Please don’t forget about me.”

Nieman said she didn’t know who at Glaxo made the note in the company’s database that the aborted fetus’ heart defects were likely linked to the woman’s Paxil use.

“Somebody from GSK filled that in,” she said. “There’s a possibility someone made a mistake and checked the box wrong.”

Lawyers for Kilker allege Glaxo mounted a marketing campaign to persuade doctors to write more Paxil prescriptions for pregnant women dealing with anxiety.

The drugmaker undertook that campaign while withholding information about birth-defect reports from doctors, the family contends.

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Fid

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