Zofran Misleading Advertisements and Lawsuits

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Zofran 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). However it was prescribed off label for women suffering from morning sickness by the physicians without FDA approval. Zofran has been given an FDA rating of “Pregnancy Category B.”. Pregnancy Category B indicates that the medication has not been proven safe for uses in pregnancy but many women have been prescribed Zofran for morning sickness. Parents claim that during early pregnancy Ondansetron can cause severe Congenital Malformations on the fetus.

More than 282 lawsuits against Zofran manufacturer has been filed against the multi-national healthcare giant GlaxoSmithKline and consolidated in the Boston federal court for pre-trial proceedings. The lawsuits allege that GlaxoSmithKline’s failure to adequately warn about the potential Zofran side effects on unborn babies and continued to market it without adequate warning labels as a “safe” and “effective” drug. The manufacturer has presented distracting elements in their commercials that gives a consumer an incorrect understanding of the product and misleads the patients as well as doctors. Drug manufacturers are required to adequately warn patients of the risks associated with their medications and include those in their advertisements. The lawsuit against Zofran alleges that the drug to treat morning sickness during Pregnancy can lead to newborns having several serious birth defects Includes:

  • Cleft lip and cleft palate
  • Heart Defect
  • Club foot
  • Stillbirth
  • Mouth Deformities
  • Fetal growth Restrictions
  • Ventricular septal defect
  • Kidney malformation
  • Bladder Defects
  • Cleft Uvula
  • Fetal death

Despite the growing number of lawsuits filed against GlaxoSmithKline (GSK) claiming birth defects from Zofran, Doctors Continue to Prescribe Zofran ‘Off-Label’ to treat the morning sickness and nausea during pregnancy. According to the FDA warnings the medication should not be used off label on pregnant women. It may increase the risk of developing severe birth defects to the fetus. This poses a serious problem for expectant mothers who experience morning sickness during the first trimester of pregnancy. Unfortunately, there’s no law stopping doctors from prescribing such drugs “off-label”. Until more research and studies are undertaken, it is unclear of the percentage of infants that may have birth defects associated with Zofran.

Medical practice guidelines advice it is illegal and unethical for manufacturers to present false or misleading commercials which hides the serious warning associated with the drugs. GlaxoSmithKline fails to warn patients of the risks associated with Zofran medication, the drug is not properly tested before going to market. 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, 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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