Morning Sickness Drug Zofran Dosage and Warnings

Written by admin

Zofran is the brand name for the generic medication, ondansetron hydrochloride. It is a type of medication called anti-emetics and belong to a class called 5HT3 receptor antagonists. Zofran is designed to cure vomiting and morning sickness in pregnant women. It blocks the actions of chemicals in the body that can trigger nausea and vomiting. Essentially, the drug blocks the serotonin neurotransmitter in the parts of the brain where nausea and vomiting are triggered. Zofran is manufactured and sold by GlaxoSmithKline. It is a medication that is only available on prescription. 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.

Does Ondansetron Zofran causes serious birth defects?

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.  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, This Zofran pregnancy category was based on a review of less than 200 births. 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
  • Inguinal Hernia

As per reports Glaxo admit that using Zofran for nausea and vomiting in pregnant women has not been tested. But that didn’t stop them from promoting off-label use of the drug. A 2011 study performed by a grant from the Centers for Disease Control and Prevention (CDC) states that Zofran doubles the risks of birth defects, the risk of developing congenital heart defects in particular significantly higher, including: 8 times higher risk of developing atrioventricular septal defects, 3 times higher risk of developing ventricular septal defects and 1 times higher risk of developing atrial septal defects. Ondansetron exposed during pregnancy possibility of a doubling in risk of cleft palate and heart defects in newborns .The key to helping women is spreading the information about the drug, and promoting awareness as much as possible.

Zofran Dosage and Approval

Zofran is available as an oral tablet (ondansetron hydrochloride), oral solution and oral disintegrating tablet and as an injection for intravenous use. The active ingredient in ZOFRAN ODT® Orally Disintegrating Tablets is ondansetron base; Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. It can be taken orally, via a rapidly disintegrating tablet (ODT), or through injections. Before using this medication, tell your doctor or pharmacist your medical history, especially of: irregular heartbeat, liver disease, stomach/intestinal problems (e.g., recent abdominal surgery, ileus and swelling).

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. Although Zofran has never been approved for this purpose, GSK began marketing the drug for morning sickness soon after it hit the U.S. market in 1991. Despite Zofran has shown effectiveness in treating nausea and vomiting, according to a several studies and trials which demonstrate that it also comes with serious zofran side effects to both mother and infant, the FDA has cautioned against its use in pregnancy.

GlaxoSmithKline has not changed its pregnancy labeling language for Zofran in any meaningful way throughout the 24 years that its product has been on the market. There are several numbers of lawsuits against the manufacturer alleging that GlaxoSmithKline fails to warn patients of the risks associated with Zofran medication, the drug is not properly tested before going to market and manufacturer negligence for safety. Any woman who was prescribed Zofran during pregnancy and then suffered from zofran birth defects like congenital heart defects, Webbed Toes, Kidney malformation or any other complications  may contact for free and confidential case review.

About the author


Leave a Comment