Today is: April 13, 2011

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Calcagno & Associates

900 South Avenue, 3rd Floor
Staten Island, NY, 10314
Phone: 1-800-WE-FIGHT
             (718) 568-3585

By appointment only

Battery Place
New York, NY, 10004
Phone: (800) 933-4448

Grand Concourse Bronx, NY, 10451 Phone: (718) 933-4448

Bay Parkway Brooklyn, NY, 11214 Phone: (800) 487-6837

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Paxil Linked to Serious Birth Defects

Paxil Taken in Pregnancy Linked to Newborn Birth Defects

Paxil (generic: paroxetine), a selective serotonin reuptake inhibitor (SSRI antidepressant), was approved by the FDA in 1992. Paxil’s manufacturer, Glaxo Smith-Kline, released an internal study in 2005 which found a 1.5 times increased risk for heart malformations in infants whose mothers took Paxil while pregnant compared with other antidepressants. The normal risk of a newborn having a heart defect is about 1 %. In the GSK study, 3,500 pregnant women taking antidepressants were examined; 4% of the women on Paxil had babies born with birth defects, compared to 2% taking other antidepressants. At the FDA’s request, Glaxo Smith-Kline changed Paxil’s labeling in September 2005 to warn about the risks of birth defects.

In December 2005, the FDA released a warning to women about the dangers of taking Paxil while pregnant. In November 2006, the American College of Obstetricians and Gynecologists warned women to avoid taking Paxil during pregnancy. Paxil has been lowered from Pregnancy Class C to Class D, signifying that studies in pregnant women demonstrate a risk to the fetus.

Paxil-related Heart Defects

Babies who were exposed to Paxil were born with atrial and ventricular septal defects more than other types of heart defects. These are holes in the heart chamber walls. Sometimes this type of defect requires the baby to undergo cardiac surgery.

Legal Help for Families Affected by Paxil Birth Defects

Our law firm is available 24/7 to answer any Paxil Birth Defect questions you may have. Contact us today for a free, no obligation, Paxil legal consultation by completing the case evaluation form on the right side of this page or by calling 1-800-WE-FIGHT (1-800-933-4448).

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