Paxil Lawsuit Attorneys

Paxil has recently been linked to an increased risk of serious-birth defects in infants born to mothers taking the drug during the first trimester of pregnancy.

Paxil, which is also known as paroxetine, is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, obsessive-compulsive disorder, social anxiety disorder, and other mental health conditions. It is estimated that doctors wrote over 37 million Paxil prescriptions in 2002 alone.

Last month, Paxil's manufacturer, GlaxoSmithKline (GSK), released a study linking first-trimester Paxil@ use to an increased risk of major birth defects in newborn infants. According to the FDA, Paxil was linked to twice as many major birth defects as other antidepressants in the study. In the GSK study, most of the birth defects were heart related. Based on this, the FDA and GSK rent letters to doctors, and changed the Paxillabel to reflect the study data.

Other recent studies have revealed that women who took Paxi I during their first trimester were six times more likely to have an infant with omphalocele, a birth defect in which the infant's intestine or other abdominal organs protrude from the navel. Studies have also shown an increased risk of craniosynostosis, a condition marked by the premature fusion of an infant's cranial sutures resulting in an abnormal head shape.

Paxil In The News

FDA Safety Information Alert - Paxil (Paroxetine)

The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine's prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.

Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.

Read the complete MedWatch 2005 Safety Summary, including links to the FDA Public Health Advisory and the FDA Drug Information Page that includes links to the Healthcare Professional and Patient Information Sheets, here.

If you or a loved one suffered a side effect from Paxil, please contact the Paxillawyers at the Law Offices of Nadrich & Cohen at (800) 718-4658. We are presently reviewing Paxil side effects cases throughout the country.

If we can help you; if you have any questions; call today,(800) 718-4658, or e-mail, info@personalinjurylawcal.com.