Zofran and Birth Defects

ZOFRAN BIRTH DEFECTS Zofran (Ondansetron) is prescribed to ease nausea and vomiting symp- toms for women during pregnancy. There are new claims that the drug is linked to birth defects involving cleft lip, cleft palate and congenital heart defects. BIRTH DEFECTS Cleft Lip Cleft Palate Congenital Heart Defects A condition where An opening or gap of the mouth that A defect present at the two plates of the birth in the structure can form on the lip and at times go all the way up to the skull that form the of the heart and roof of the mouth vessels are not completely joined. nose. IMPORTANT INFORMATION FDA APPROVED Zofran is prescribed off-label to treat morning sickness and Zofran was approved by the FDA in 1991 to treat and prevent chemotherapy-induced nausea and vomiting. nausea during pregnancy. In 2012, the Zofran manufacturer GlaxoSmithKline plead guilty and paid $3 billion to resolve a DOJ lawsuit arising from the company's unlawful off-label promotion of certain prescriptions drugs, including Zofran. Without Zofrgn With Zofran A 2011 study suggested the drug doubled the chance of babies being born with a cleft palate. BROUGHT TO YOU BY A DrugDangers Sy SEEGERWEISSLP COMPLEX LITIGATION | SIMPLE JUSTICE Sources: www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/ www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report Copyright © 2015 DrugDangers.com