Zofran® and Pregancy Side Effects

July 24, 2014

Zofran® During Pregnancy Warning

Zofran given for pregnancy related morning sickness has become widely prescribed to pregnant women for morning sickness, even though the FDA has not approved Zofran to be taken during pregnant for morning sickness or nausea and vomiting of pregnancy (emesis gravidarum or NVP). It is believed that over one half of all pregnant women suffer from these symptoms. Morning sickness can occur throughout the day, but for most women this pregnancy side effect resolves by the 12th week or end of 1st trimester.

Zofran® for Morning Sickness Not Approved by FDA

Zofran (Ondansetron) is a serotonin 5-HT3 receptor antagonist originally used for and approved by the FDA to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy. Only later did Zofran’s “off label use”  for morning sickness begin.  Recent medical studies indicate that taking Zofran while pregnant is ill advised and not an approved use by the FDA.  Zofran warnings regarding its use during pregnancy are just beginning to be spread. According to a 2014 Zofran medical study the use of Zofran for pregnancy related NVP or morning sickness can increase the risk of  congenital heart defects, hypospadias, cleft palate, cleft lip and possibly neural tube defects.

Conflicting studies have come out in the last two years with conflicting results and conclusions as to Zofran Pregnancy Safety. Many more questions need to be answered including whether Zofran and breast feeding is safe. Some mothers worry that using Zofran while breast feeding can pass any bad effects or toxins in the breast milk. Our concern on birth defect cases deals with birth defects to the fetus due to the mother taking Zofran during the first and second trimester of pregnancy.

NOTE: Currently the Willis Law Firm is representing a number of mothers that took Zofran in their pregnancy and their babies were born with a birth defect. Many of these babies have had to undergo open heart surgeries for their heart defects.(Dec. 2014)

Zofran® Pregnancy Category

Currently the Zofran pregnancy category is a “B” has been called into question by some medical experts as to the rise in birth defects due to Zofran usage by pregnant women for morning sickness.  The pregnancy category of a medicine or pharmaceutical agent is an assessment of the risk of fetal injury due to the use of that drug or pharmaceutical by the mother during pregnancy. This pregnancy category risk  does not include any risks conferred by the drugs or pharmaceutical agents or their metabolites in breast milk, but rather only during pregnancy.

CATEGORY B- No risk in other studies: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. (Source: Wikipedia)

Using this accepted definition of Pregnancy Category B, is why some medical experts question in light of some of the studies, that Zofran’s Pregnancy Category shouldn’t at least be raised to a drug Pregnancy Category C since increased risks have been concluded to a human fetus.

CATEGORY C –Risk not ruled out: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.


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. You and your child may have a right for monetary compensation for medical expenses, pain and suffering, disfigurement, loss wages and other damages and injuries.

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

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