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Glaxo Accused Of Ignoring Paxil Birth Defect Risks

Sep 16, 2009 | Parker Waichman Alonso LLP

Last week we wrote that drug maker GlaxoSmithKline Plc was scheduled to defend itself in a Philadelphia court this week over allegations its blockbuster antidepressant Paxil, (generic: paroxetine) can lead to birth defects when taken by pregnant woman. Bloomberg.com described the lawsuit as a “test case” for some 600 other similar cases.

According to Philly.com, at the start of that trial this week, a plaintiff's attorney claimed Glaxo  ignored information that Paxil caused birth defects.  The lawyer represents  a mother who said her three-year-old son is suffering from cardiac issues because she took Paxil while pregnant. The attorney also told the jury that Glaxo advised its scientists to not reveal any potential risks Paxil presented to pregnant women, Philly.com said.

Patients and their parents claim that internal Glaxo documents show the drug maker neglected to publicize warnings about Paxil’s risks until it was compelled to do so by the U.S. Food and Drug Administration (FDA) in 2005, said Bloomberg.com, last week. Paxil was approved by the agency in 1992.

Although Glaxo argued that its drug did not cause the boy’s heart problems, the woman’s lawyer noted that in initial testing, when rats received Paxil, their pups did not live more than four days. Plaintiff attorneys claim Glaxo’s paperwork prove it was aware Paxil could increase birth defect risks as far back as 1980 and that it did not fully research Paxil before—and after—release to market, said Bloomberg.com, previously.

The attorney pointed out that going back to the late 1980s, a Glaxo scientist stated that, "there remains the possibility that Paxil could cause birth defects at higher doses," reported Philly.com. According to the attorney, for two decades, Glaxo allegedly neglected to understand what caused the rat pups, whose mothers took Paxil when pregnant, to die, said Philly.com. “There remains the possibility that this compound could be teratogenic at higher dose levels. A teratogenic agent is one that causes malformations of an embryo or fetus,” wrote company scientist John Baldwin in a 1980 memorandum, quoted Bloomberg.com.

According to the 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. The government asked Glaxo to update medication information warning on birth defects.

An attorney for Glaxo argued that while the boy was hospitalized for months following his birth and underwent cardiac surgeries that today, he "has no cardiac symptoms … is at preschool and runs and walks like a 4-year-old should," quoted Philly.com. The boy’s attorney argued that the boy will need more cardiac surgery.

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.

Worse, 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.