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Increase in Risk of Birth Defects caused by famous Nausea drug Zofran

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Ondansetran, better known by its brand name, Zofran is a medication that is only available on prescription.Zofran was initially manufactured by GlaxoSmithKline. It was the first drug in its class that was available and it was approved by the FDA in 1991. It is designed to cure vomiting and morning sickness in pregnant women. Pregnant women experiencing severe symptoms are often prescribed the medication during the first trimester. Zofran works by blocking chemicals in the body responsible for nausea and vomiting.  Essentially, the drug blocks the serotonin neurotransmitter in the parts of the brain where nausea and vomiting are triggered. It can be taken orally, via a rapidly disintegrating tablet (ODT), or through injections. Despite Zofran has shown effectiveness in treating nausea and vomiting, according to a current study which demonstrate that it also comes with serious side effects to both mother and infant.

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FDA warnsagainst Zofran Use in Pregnancy

As per the latest update released by FDA a few weeks ago, it warns that Zofran has been approved as a drug to treat nausea and vomiting, but only in patients who have undergone chemotherapy or radiotherapy, or who are experiencing nausea after surgery. According to the FDA warnings the medication should not be used off label on pregnant women. It may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.” This poses a serious problem for expectant mothers who experience morning sickness during the first trimester of pregnancy. In its 2011 warning, the FDA stated that changes in the electrical activity of the heart can lead to a potentially life-threatening heart rhythm, such as Torsade de Pointes, a condition characterized by an abnormal heart rhythm that can result in sudden cardiac death.Although Zofran has been in the market of United States from more than 20 years, The drug comes several types of birth defects include;

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

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. Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.

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