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GlaxoSmithKline Sued Over Paxil Birth Defects

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A lawsuit was filed against GlaxoSmithKline on July 28, 2006, in Philadelphia on behalf of Adrian Vasquez, who was born on April 19, 2004, with birth defects as a result of his mother, having been prescribed Paxil during pregnancy. Paxil belongs to the class of antidepressant drugs known as selective serotonin re-uptake inhibitors (SSRIs).

At birth, Adrian was suffering from several life-threatening congenital heart defects. Beginning when he was eight days old, Adrian underwent three open heart surgeries in attempt to repair his heart. Each surgery lasted several hours and each time his parents were informed that his chance of survival was low.

In March 2005, Adrian underwent another surgery and a pacemaker was installed. He was discharged from the hospital on April 3, 2005, just weeks before his first birthday.

As Adrian continues to grow, his attorneys say, he will need repeated surgeries to replace a conduit, maintain his pacemaker, receive artificial replacement valves inserted into his heart and he is also said to be at risk of needing a heart transplant.

The California based Baum Hedlund law firm filed this latest lawsuit and represents many families whose children were born with heart birth defects to mothers who took Paxil. The firm's birth defect team is also investigating cases concerning lung, cranial and abdominal birth defects related to Paxil.

The law firm has been handling SSRI-related cases since 1990. Baum Hedlund partner, Karen Barth Menzies, leads the firm's SSRI Litigation Department and is lead counsel for the Plaintiffs' Steering Committee (MDL-1574) Paxil Products Liability Litigation. She is also leading the team of birth defect attorneys handling the Paxil cases.

In 2005, Ms Menzies was named one of the National Law Journal's Top 40 Under 40, for her "extraordinary achievements" and "impressive track record" in "stepping up her fight in the past few years, advocating that pharmaceutical companies should warn about the alleged risks of antidepressant drugs."

The Vasquez lawsuit complaint alleges that Glaxo, "promoted and maintained Paxil on the market with the knowledge of Paxil's unreasonable risk to the public in general and specifically to plaintiff."
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The complaint also charges that Glaxo, "by directly and indirectly advertising, marketing, and promoting Paxil for the treatment of women during pregnancy and by placing this drug in the stream of commerce knowing that Paxil would be prescribed to pregnant women in reliance upon the representations ... that Paxil was safe and effective for the treatment of women during pregnancy and without significant risk to the fetus."

The lawsuit also alleges that Glaxo "did not timely warn the medical community and consumers generally that taking Paxil during pregnancy is associated with a significant increased risk of birth defects and abnormal development of the unborn child."

Legal experts predict that lawsuits involving SSRI-related birth defects will be hard for drug companies to defend against because of the steady stream of studies in recent years that have documented the many adverse effects of SSRI use on the unborn fetus; making it impossible for the drug makers to feign ignorance.

Although there have been many studies evaluating SSRI effects on newborns, medical researchers say they do not have enough information to determine what effects SSRI exposure in the womb may have on the overall long-term health of infants.

In 2003, scientists reported that SSRIs readily cross the placental barrier and expose the infant to increased serotonin levels during early development, in a study published in the American Journal of Psychiatry (2003; 160:993-996)
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Early the following year, on February 22, 2004, the Chicago Sun-Times reported that pregnant women who use SSRIs could be damaging the brains of their unborn babies after a study published in the American Journal of Pediatrics found direct evidence of a link between fetal exposure to SSRIs and disrupted neurological development.

"Researchers linked abnormal sleeping patterns, heart rhythms and levels of alertness to drugs called selective-serotonin re-uptake inhibitors," the Sun-Times wrote.

The study's lead researcher, Philip Zeskind, a professor of pediatrics at the University of North Carolina-Chapel Hill, said babies exposed to the drugs tended to be locked in one "sleep state," and showed "fewer of the smooth and predictable changes in heart rate that normally occur in newborn infants," and that the results were alarming and demanded a follow-up.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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