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Parents Enraged At Glaxo Over Paxil Birth Defects

By       Message Evelyn Pringle     Permalink
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On July 28, 2006, a lawsuit was filed in Philadelphia against GlaxoSmithKline, on behalf of Adrian Vasquez, an infant born on April 19, 2004, with life-threatening congenital heart defects as a result of his mother having been prescribed Paxil during pregnancy.

Since birth, beginning when he was 8 days old, Adrian has undergone three open heart surgeries in an attempt to repair his heart. Each time, his parents were advised that his chance for survival was low.

In addition to the surgeries, he also underwent at least four cardiac catheterizations, and thirty echocardiograms within the first few months of his life. In March 2005, surgeons operated on Adrian again to install a pacemaker.

He remained hospitalized for nearly a year before being released on April 3, 2006, just 2 weeks short of his first birthday.

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As Adrian matures, experts say, he will need repeated surgeries to replace a conduit, maintain the pacemaker, and have artificial replacement valves inserted into his heart. Even then, they say, he may end up needing a heart transplant.

Mrs. Vasquez first learned that there were problems with her baby's heart during an ultrasound in her last month of pregnancy. She had taken Paxil throughout her pregnancy.

Baum Hedlund, a national pharmaceutical products liability law firm in Los Angeles, Washington, D.C. and Philadelphia, represents the Vasquez family. According to Baum Hedlund attorney Karen Barth Menzies:

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"Adrian Vasquez is a tough little boy. The trauma he has endured in his brief two years of life is much more than most of us will ever have to suffer in our entire lifetime."

It is now known that in 2003, GSK conducted an analysis of women, dating back to 1995, who had taken antidepressants in the first trimester of pregnancy and given birth to infants with major congenital malformations. The analysis showed a more than 2-fold increase for malformations in women taking Paxil compared to other antidepressants.

According to Ms. Menzies, "The seriousness of these birth defects are such that, at the very first sign of danger, GSK should have issued a strong warning."

It stands to reason, experts say, that because doctors and patients were not made aware of the problem, there are probably infants with heart defects all over the country whose parents have no idea that they were caused by Paxil.

Ms. Menzies points out that over 1 percent -- or 40,000 -- pregnant women in the US are taking antidepressants. "Given the popularity of Paxil," she warns, "thousands of babies are at risk."

She may be right, because more cases of this type of birth defect are showing up in the media. On August 2, 2006, Texas Cable News reported heart defects in a 9-month-old baby from Brazoria County, Texas born to a mother who had taken Paxil during the first trimester of pregnancy, who was at the time of the broadcast, on life-support surviving with only half a heart.

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According to the broadcast, this infant has already undergone one open-heart surgery and has made at least a dozen trips to the emergency room.

The mother, Lisa Collins, told Texas Cable News that she believes it could have all been prevented had her doctor warned her not to continue taking Paxil.

Lisa is probably right but the problem is that Glaxo did not warn doctors about the risk of heart defects until September 2005, when the company sent out a "Dear Doctor" letter saying the results of its analysis showed a higher rate of "congenital malformations associated with the use of Paxil as compared to other antidepressants" in infants born to women taking antidepressants during the first trimester of pregnancy.

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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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