FDA Zofran® Pregnancy Warning

October 24, 2014

FDA Warns Against Zofran® Use in Pregnancy

The FDA has issued an updated warning against Zofran – Ondansetran, use in pregnancy. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nausea and vomiting with cancer chemotherapy patients, but its off-label use to treat morning sickness  nausea and vomiting in pregnancy that is causing concerns among some medical experts.

This Zofran warning is based on recent medical studies regarding Zofran use induring the first and second trimesters of pregnancy and congenital cardiac malformations / Zofran heart defects , oral clefts (Zofran cleft lip and Zofran cleft palate in babies born to mothers taking Zofran. The FDA has cautioned Doctors about prescribing Zofran to pregnant women until its safety on the fetus is better known.

Many Zofran pregnancy side effects from our current 100+ clients include: Atrial Septal Defects (ASD), Ventricular Septal Defects, Cleft Lip, Cleft Palate, Transposition of the Great Arteries (TGA) or Vessels, Coarctation of the Aorta (CoA), Tetralogy of Fallot  (TOF), Hypoplastic Left Heart Syndrome (HLHS), gastrochesis, club foot, holes in heart walls, bad heart valves and spina bifida and other neural tube defects and a number of deaths after birth.

FDA Zofran® Warning of Heart Rhythm Problems

In 2011 the FDA alerted healthcare professionals and Zofran patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron), that it may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can often lead to an abnormal and potentially fatal heart rhythm, including a condition called Torsade de Pointes.


Zofran® Birth Defects Lawsuit – Talk to Lawyer

If you took Zofran while pregnant and your child was born with a serious birth defect, then call for a Free & Confidential Zofran Lawsuit Evaluation.

Talk to a Board Certified Personal Injury Trial Lawyer licensed in Texas and in New York with a National Presence with the Highest Peer Review Rating. All Zofran birth injury cases are taken on a contingency fee basis and the client is never charged an attorney fee or any legal case expenses unless a recovery is obtained.

To contact a lawyer to discuss a potential Zofran Birth Defect Lawsuit or call us Toll Free 1-800-883-9858

© Willis Law Firm for Drug Attorneys. Replication strictly prohibited without written consent.