Paxil® Linked To Birth Defects and Congenital Malformations

October 2005

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Tara Sutton

U.S.health officials and GlaxoSmithKline are warning doctors about the risk of major birth defects in infants born to women who take Paxil® during their first trimester of pregnancy.[1]

GlaxoSmithKline, the manufacturer of Paxil®, recently conducted a study of major birth defects in infants born to women who took antidepressants (including Paxil®) during the first trimester of pregnancy.[2] Preliminary results linked first-trimester Paxil®use to an increased risk of major birth defects. According to the FDA, Paxil® was linked to twice as many major birth defects as other antidepressants in the study. Most of the birth defects were heart related.

Other recent studies have revealed that women who took Paxil® 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.[3]

Paxil®, known as paroxetene, 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.

The FDA warns physicians to carefully weigh the potential risks and benefits of prescribing Paxil® to women during pregnancy and discuss the risks and treatment alternatives with their patients.

If you or someone you know took Paxil during pregnancy and had a child born with birth defects, and you wish to consult with us, please call Tara Sutton at 612-349-8577 or Kathy Neuman, Legal Nurse Consultant, at 612-349-8513. You can also send them an e-mail by clicking on this link: contact us .

^[1] Go to http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil2 to read the new warning

^[2] To read the study, go to http://ctr.gsk.co.uk/Summary/paroxetine/studylist.asp

^[3]Alwan S, Reefhuis J, Rasmussen S, et al., “Maternal use of selective serotonin re-uptake inhibitors and risk for birth defects.” Birth Defects Research (Part A): Clinical and Molecular Teratology 2005 ;731:291.

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Paxil® Linked To Birth Defects and Congenital Malformations

October 2005

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