Zofran® Use During Pregnancy Not Approved by FDA

Zofran an anti-nausea medication is being prescribed “off label” to pregnant women for morning sickness. The serious problem is Zofran is not FDA approved to be used during pregnancy, but rather to patients with nausea side effects going through chemotherapy and for surgery patients. Zofran (ondansetron) is in a class of medicines called 5-HT3 receptors antagonists and has been shown to increase the risk of developing a fatal heart rhythm especially in patients with underlying heart conditions.

Zofran Promoted to Doctors

ObGyn’s and other Doctors prescribing Zofran for an UN-APPROVED use or treatment is legal, but can also be risky to the fetus of the mother. GlaxoSmithKline(GSK) in fact has been quietly marketing and promoting Zofran to be prescribed to pregnant women. In fact GSK paid approximately $2,000,000,000 (Two Billion Dollars) in a civil law suit involving allegations that GSK promoted Zofran to Doctors who in turn prescribed it to pregnant women. Zofran was never approved by the FDA for use during pregnancy. The potential side effects of Zofran during pregnancy was never fully tested by Zofran at the time it was first submitted to the FDA in 1991 or at time of FDA approval for use in 1993. Zofran is sold in 4mg and 8mg tablets and in Zofran ODT (Oral Disintegrating Tablets) and later the FDA approved generic Zofran in Dec. 2006.

Zofran Side Effects to a Baby

Zofran’s side effects to a baby or fetus during the first trimester has many experts in the medical world concerned about its use during pregnancy, as Zofran  has been shown to cross the placental barrier and move or transfer into fetal tissue during the critical cell and tissue building and organ development that take place in the first trimester of the baby in the womb.

According to Zofran Pregnancy Side Effect studies in 2013 and 2104, a significant rise on congenital heart defects or cardiac malformations along with oral cleft defect, cleft lip and cleft palate has been seen. Again GSK has never sought approval of Zofran to be sold to pregnant women as the obvious fetal side effects would likely prevent FDA approval for Zofran use during pregnancy. Sadly however, Zofran is prescribed during pregnancy at an alarming rate and is also given to nursing mothers breast feeding their newborn. No Zofran breast milk side effects studies published to date. Even today with all the Zofran warnings and “red flags” that exist with the Zofran Heart Defect Studies and Zofran Cleft Lip Studies and test results, GSK still insists that no warning are needed and that Zofran is Safe to be given during pregnancy as it seen in the still current Zofran Pregnancy Category B designation.

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Zofran® Pregnancy Birth Defects Lawsuit – Talk to Lawyer

If you took Zofran during pregnancy and later your child was born with a heart defect, cleft lip or cleft palate or other 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 Side Effect Lawsuit or call us Toll Free 1-800-883-9858

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