Child Born with Severe Heart Birth Defects Sues Paxil-Maker

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Fri, 28 Jul 2006 15:25:05 -0400

[sSRI-Research] Child Born with Severe Heart Birth Defects

Sues Paxil-Maker

 

 

 

 

July 28, 2006

 

FOR IMMEDIATE RELEASE

 

Baum Hedlund

12100 Wilshire Blvd., Ste. 950

Los Angeles, CA 90025

Contact: Robin McCall, Media Relations

Day: (800) 827-0087 or (310) 207-3233

Cell/weekends: (818) 681-5697

Email:RMcCall

Web: www.paxilbirthdefect.com

www.baumhedlundlaw.com

 

Child Born with Severe Heart Birth Defects

Sues Paxil-Maker

 

Philadelphia, Pennsylvania, July 28, 2006 -- Two-year-old Adrian

Vasquez has undergone three open-heart surgeries and now has a

pacemaker. His mother took the antidepressant Paxil throughout her

entire pregnancy.

 

Adrian and his parents, Anthony and Matilda Vasquez of Bedford, Texas,

filed a lawsuit today against Philadelphia-based GlaxoSmithKline

( " GSK " ), the maker of Paxil, in Pennsylvania State Court. The family

alleges that Mrs. Vasquez's ingestion of Paxil during her pregnancy

resulted in her son being born with severe heart defects. The Vasquez

family is seeking an unspecified amount of damages against GSK for

failing to warn about the risks associated with Paxil for pregnant

women and their unborn children.

 

According to Baum Hedlund attorney Karen Barth Menzies, who represents

the family: " 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. The seriousness of

these birth defects are such that, at the very first sign of danger,

GSK should have issued a strong warning. Over 1 percent -- or 40,000

-- pregnant women in the US are taking antidepressants. Given the

popularity of Paxil, thousands of babies are at risk. "

 

During the last month of her pregnancy, Mrs. Vasquez learned, while

receiving an ultrasound to determine the sex of her baby, that there

was something very wrong with her baby's heart. When Adrian was born a

few weeks later, on April 19, 2004, in Norfolk, Virginia, he had

several life-threatening congenital heart defects. His parents were

repeatedly told that his chances of survival were low.

 

During the first year of his life, Adrian underwent three open-heart

surgeries (at eight days, five months and 10 months) due to his heart

defects. He also underwent at least four cardiac catheterizations, and

at least thirty echocardiograms within the first few months of his life.

 

Adrian is now two years old and, while he is behind in his verbal and

motor skills, his health has improved. Adrian will, however, need

repeated heart surgeries as he continues to grow and may need

artificial replacement valves, and perhaps eventually a heart

transplant. His prognosis is unclear. [see Fact Sheet for more

information about the Vasquez family.]

 

The Vasquez family is represented by Baum Hedlund, a national

pharmaceutical products liability law firm in Los Angeles, Washington,

D.C. and Philadelphia. [see Fact Sheet for more information about Baum

Hedlund.]

 

In 2003, GSK initiated a retrospective analysis of women, dating back

to 1995, who had taken antidepressants in the first trimester of their

pregnancies and had given birth to children with major congenital

malformations. The analysis showed a more than 2-fold increase for

congenital malformations in women taking Paxil compared to other

antidepressants.

 

Another study conducted by researchers in Denmark and published in

Pharmacoepidemology and Drug Safety in 2005, also found an association

between Paxil and congenital malformations in mothers taking Paxil in

the first trimester.

 

In September 2005, GSK sent out a " Dear Doctor " letter informing

physicians throughout the United States that 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. The most common malformations for mothers taking Paxil were

cardiovascular, particularly ventricular septal defects ( " VSD " ).

 

The FDA has issued three Public Health Advisories since December 2005

concerning the risk of congenital heart defects and has changed

Paxil's pregnancy category from C to D, which indicates that " [t]here

is positive evidence of fetal risk. " [see Fact Sheet for more

information.]

 

A photo is included of Adrian Vasquez taken in March 2005, about a

month after his third open-heart surgery. (A higher resolution photo

is available upon request through Baum Hedlund.) The family is

available for interviews through their attorney, Karen Barth Menzies.

 

FACT SHEET attached.

 

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Robin McCall of Media Relations

Baum Hedlund

RMcCall

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