Hundreds of Lawsuits Claim Paxil Causes Birth Defects

-ParentDish

03/11/2010 - The makers of the antidepressant drug Paxil are facing an increasing number of lawsuits alleging the medication causes birth defects, and one family has already won a settlement of $2.5 million, online investigative news site The Public Record reports.

Paxil's manufacturer, GlaxoSmithKline, also has been sued by plaintiffs alleging the drug is addictive and can make people suicidal, The Public Record reports. To date, the company has paid out more than $1 billion to resolve the lawsuits. Paxil was approved by the FDA in 1992.

So far, only one lawsuit alleging the drug causes birth defects has been brought to trial. In October 2009, a jury in Philadelphia awarded the family of Lyam Kilker $2.5 million after it brought forward a suit claiming Paxil caused Kilker's severe heart defects.

In all, more than 600 cases alleging Paxil caused birth defects have been filed in the Philadelphia Court of Common Pleas, and last year 25 of those came up for trial. GlaxoSmithKline is based in London but has major operations in the Philadelphia area.

In September 2005, GSK added a warning to the "precautions" section on the Paxil label, advising users that two studies showed an increased risk of birth defects in pregnant women taking the drug. Most of the cases being brought to court involve children born before the warning was added, Vickery says. That warning has been made stronger several times since, most recently in August 2009.

Despite the studies and the warning in its own literature, GSK contends that "the scientifically available evidence is insufficient to establish that use of paroxetine during pregnancy causes birth defects," according to a statement provided to ParentDish. Paxil is the trade name for paroxetine.

"Patient safety is a priority at GSK," a company spokeswoman tells ParentDish.

The next Paxil case is scheduled for trial this June. That case involves 7-year-old Delaney Novak, who was born with heart defects. Her mother, Laura, was prescribed Paxil for migraine headaches, Vickery says, an off-label use.

Drugs are put into categories for pregnant women, with category A being the least harmful. Paxil is in category D, and is the only SSRI [serotonin inhibitor] antidepressant in that category, Vickery tells ParentDish.

"There's no reason to take it," Vickery says. "It should be the absolute last resort."