Zofran Lawsuit : Animal Studies were inaccurate

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Zofran, (brand name for generic medication “odansetron hydrochloride”) is an FDA-approved anti-nausea drug that blocks the actions of chemicals in the body that can trigger nausea and vomiting. Zofran is not approved to treat morning sickness in pregnancy. It is approved to prevent nausea and vomiting in patients undergoing certain types of surgery or cancer treatment (chemotherapy or radiation). World’s largest manufacturer GlaxoSmithKline manufactured this medication available in different forms such as oral tablets, oral solution and injectable formulations for use of intravenous and disintegrating tablets. Doctors continue to prescribe Zofran to pregnant women despite the adverse effect of the drug. Women who take the medication during pregnancy gave birth to babies with birth defects, including cleft palates and lips, club foot, heart defects and Skull deformities. Medical practice guidelines advice It is illegal for physician to prescribe an off label medication for unapproved uses and without proper clinical testing

Zofran has been given an FDA rating of Pregnancy Category B, which means animal studies failed to demonstrate a risk to the fetus and there were no adequate and well-controlled studies in pregnant women at the time it was approved. On August 14th, 2015 a lawsuit, filed in the United States District Court for the District of Idaho claims that Zofran animal studies were inaccurate. The zofran lawsuits were filed under the case number 1:15-CV-00319-BLW. The several animal studies conducted by the pharmaceutical were unreliable in determining if Zofran would be safe for expectant mothers and their unborn children. In 2013, a Danish Study titled “Ondansetron use in early pregnancy and the risk of congenital malformations” found a 2-fold increased risk of heart defects in babies whose mothers used ondansetron in pregnancy. Instead of using these animal studies to provide warnings to pregnant women, the makers of Zofran, GlaxoSmithKline, decided to withhold the evidence.

New Zofran pregnancy studies of hundreds of thousands of births show that it may cause fetal harm. The possible birth defects caused by Zofran may include Cleft Palate, Kidney malformation, Congenital heart defects, Facial Dysmorphia, Skeletal defects, Stillbirth, Hearing Loss, Fetal growth restriction, Webbed Toes and Inguinal Hernia. According to court documents, GlaxoSmithKline, the manufacturers of ondansetron, knew as early as the 1990s that the medication has the potential to cause birth defects. But the manufacturer actively defended its product and failed to provide adequate warnings and communications to the medical community and end line consumers of the increased risk of birth defects associated with these drugs. GlaxoSmithKline not only marketed Zofran as a safe way to treat morning sickness, but the company also falsified animal studies on the drug.

The drug is not properly tested before going to market as a result more than 280 Zofran lawsuits are pending in the U.S. District Court; District of Massachusetts. If you or someone you know took Zofran and had a baby born with cleft palate, cardiac malformations, kidney malfunctions and other severe Congenital Malformations or any kind of zofran side effects , please contact for a free case review. Our experience attorney’s team are dedicated to protecting consumers through individual litigation, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.





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