Paxil Costs Maker $1 Billion in Damages
Paxil became a blockbuster antidepressant drug after it debuted in 1993, but it turns out the amount its maker, GlaxoSmithKline, has already paid out to patients and others injured by the drug also is approaching the one-billion-dollar mark.
According to a Bloomberg.com report, Glaxo has shelled out hundreds of millions of dollars in damages to settle lawsuits accusing the drug of causing suicidal thoughts. The company also has paid to resolve lawsuits alleging violations of antitrust and fraud regulations related to the marketing of Paxil.
So far, about 450 suicide-related Paxil cases have been settled and only about a dozen remain unresolved, Bloomberg reports. However, the $1 billion figure being reported does not include more than 600 claims that Paxil caused birth defects, which have been filed in courts across the United States since about 2003.
In October, jurors in Philadelphia ordered Glaxo to pay $2.5 million to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his mother took Paxil while pregnant. That verdict could open the door to similar awards to families of babies born with birth defects due to Paxil use, analysts say.
Some say the company’s liability for birth-defect suits alone could one day top $1.5 billion.
Paxil Linked to Increased Birth Defects
Women who take Paxil during pregnancy are more likely to have babies with life-threatening heart malformations compared to women who take other antidepressant medications, studies have found. A 2005 Glaxo-funded study found that 1.5 percent of babies born to women taking the drug had heart malformations called atrial and ventricular septal defects.
The typical rate for these types of birth defects is around one percent, so Paxil increased the risks by one half percent, the study found. In many cases, babies born with the heart defects must be rushed into cardiac surgery in an effort to correct the problems and restore normal functioning of the heart.
Concerns about Paxil’s link to birth defects prompted the FDA in 2005 to require Glaxo to revise the drug’s labeling to warn of the risks. Also in 2005, the FDA warned women about the dangers of taking Paxil during pregnancy and the increased risks of birth defects associated with taking the drug.
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