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By Herb Newborg

Glaxo Accused Of Ignoring Paxil Birth Defect Risks and Withholding Evidence of Harm
Company official testifys risks were known since 2001. Plans were made to bury negative study data.

GlaxoSmithKline for years ignored evidence that its antidepressant Paxil may have caused birth defects, a lawyer told a Philadelphia jury yesterday. Testimony from GlaxoSmithKline officials suggest that the drug company knew that Paxil could cause birth defects as early as 2001 and that the company planned to bury negative studies linking its blockbuster antidepressant drug to birth defects.

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.

The revelations came during the first trial out of about 600 product liability lawsuits pending against Glaxo over the Paxil birth defect risks.

During testimony presented to a Pennsylvania jury, Glaxo officials indicated in 2001 that they were “almost certain” that Paxil caused a heart defect in an unborn fetus. Former Glaxo drug-safety executive Jane Nieman testified that the determination was made by an unidentified Glaxo employee in the company’s database after the mother emailed the company inquiring if there was a connection between her use of Paxil and the birth defect.

“I don’t know who made that assessment, but it’s there,” Nieman testified in a videotaped deposition played for jurors.

Bury the Negative Evidence

A Glaxo official urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial.

The Philadelphia trial stems from a lawsuit brought by the family of 3-year-old Lyam Kilker, who was born with life-threatening heart defects. Kilker’s mother, Michelle David, claims that the company withheld vital birth defect risk information from consumers, which would have prevented her from taking the medication during pregnancy. The lawsuit also claims that the company aggressively promoted Paxil for use in pregnant women even after suspecting that Paxil side effects caused birth defects.

1980 Rat Studies Identified the Risk

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

By 1997, the company received reports of 50 miscarriages or intrauterine deaths. When Glaxo studied whether there was a connection between Paxil and birth defects, its scientists called the number of cases an "alarming finding." But they did not include those words in the final version of the report or give the report to the U.S. Food and Drug Administration, even though it was required to do so, Tracey said.

Tracey said that in 2001, after a woman reported to Glaxo that she had been taking Paxil and had terminated her pregnancy because of birth defects, company scientists said they were "almost certain" that Paxil had caused the birth defects. But GSK did not tell the woman or the FDA that, Tracey told the courtroom.

"What they did next was nothing," he said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student, told jurors that Glaxo hid Paxil’s problems to protect its profits.

The FDA initially classified Paxil as a drug with no known connections to birth defects. In 2005, the agency reclassified it as a drug with some evidence of human fetal risk but allowed doctors to continue prescribing the drug to women of childbearing age if the benefits outweigh the risks.

The FDA released an alert about the risk of birth defects from Paxil on December 8, 2005, after studies showed the drug could increase the risk of heart problems in infants when taken during the first three months of pregnancy. At that time, the agency also required the company to update Paxil label warnings to include the risk of birth defects.