Emails Over Paxil Birth Defect Side Effects Must Be Turned Over

A federal judge has ordered that emails between GlaxoSmithKline PLC (GSK) and researchers over Paxil birth defects must be turned over to a family that has filed a lawsuit against the drug maker over the death their infant son.

The Paxil lawsuit was filed by the family of William Seale, a one-year-old who died from heart defects in 2004 after his mother took the antidepressant during pregnancy.

On Tuesday, U.S. District Judge Nancy Gertner in Boston, denied a motion seeking to block the family’s access to e-mails between Glaxo and researchers at the Slone Epidemiology Center at Boston University, who were studying Paxil birth defect side effects. Opening statements in the trial began on Tuesday.

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The family’s lawsuit claims that Glaxo attempted, in some cases successfully, to influence researchers to hide or downplay evidence of Paxil side effects for babies born to women taking the drug to better insulate the company from lawsuits. The company and the researchers deny the claims, although researchers said they rejected several requests by Glaxo to make changes in the manuscript of the study’s results that were submitted to the New England Journal of Medicine. The study was funded by Glaxo.

Judge Gertner denied a request by the family to access the raw data from the study after researchers and academic officials complained that granting such a request would have a negative effect on scientific research.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

About 600 lawsuits have been filed against the company, with plaintiffs claiming that Glaxo knew about the potential for Paxil to cause birth defects, but hid data and failed to warn users of the potential side effects. The FDA released an alert on December 8, 2005, after studies showed the drug could increase the risk of heart defects in infants when taken during the first three months of pregnancy. The agency also required the company to update Paxil label warnings to include the risk of birth defects.

The first Paxil birth defect lawsuit to go to trial began on Monday, a day before the William Seale claim, and was brought by Michelle David, the mother of Lyam Kilker, a 3-year-old boy who has heart defects that she says are due to Paxil side effects. In opening statements in the trial in Philadelphia, David’s lawyers read the jury a memo from Glaxo executives that discussed burying negative study results suggesting Paxil caused birth defects.


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