Testimony from GlaxoSmithKline officials suggest that the drug company knew that side effects of Paxil could cause birth defects as early as 2001, lending some support to claims that the company suppressed or downplayed the drugs’ birth defect risks.
The revelations came during the first trial out of about 600 product liability lawsuits pending against Glaxo over the Paxil birth defect risks, which allege that the company hid test data and failed to adequately warn about the increased risk of persisitent pulmonary hypertension in newborns (PPHN) and other heart problems when the drug is used during pregnancy.
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.
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, according to a report by Bloomberg News. 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.
The Philadelphia trial, which started last week, 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.
The drug maker has rejected the Paxil lawsuit claims, arguing that they responsibly tested the drug and are not liable for Lyam Kilker’s birth defects, which have resulted in multiple corrective surgeries.
Nieman testified that she did not know who at Glaxo made the determination that Paxil was likely connected to birth defects, and even said the determination could have been a clerical error. The plaintiffs’ attorneys contend that the database entry is evidence that the company knew the risks before Michelle David took Paxil and covered up the side effect.
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.