Possible Zofran Link to Birth Defects
February 27, 2015
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Use of Zofran in the first trimester of pregnancy has now been linked to birth defects.

What is Zofran?

Zofran is a drug that the FDA approved to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Zofran is manufactured by GlaxoSmithKline and was initially manufactured by GlaxoWellcome prior to the 2000 merger of GlaxoWellcome and SmithKline Beecham PLC.


Off-Label Use on the Rise

The use of Zofran, also known as ondansetron, for the treatment of nausea and vomiting in pregnancy has steadily increased from 50,000 prescriptions per month in 2008 to 110,000 at the end of 2013.

Scientists’ Research

The rise in prescribing ondansetron to pregnant women has been the subject of several studies in the last decade, with conflicting results and scientists from Toronto to Denmark saying more research is needed. Even worse, since morning sickness is most often associated with the first trimester of pregnancy, women prescribed Zofran are taking it during an infant’s most crucial development period.

In February 2013, scientists published in the New England Journal of Medicine a study of 2,000 women from a Danish birth registry spanning from 2004 to 2011. It revealed that the medication did not pose harm to fetuses. However, half the women in the study began taking the drug at about 10 weeks – past the window of time when malformations could develop.

In August 2013, scientists met at the International Society of Pharmacoepidemiology meeting in Montreal. A different group of Danish researchers revealed results from their study. They used the same data used in the February 2013 study only expanded it. They used the same national registries, but with more pregnancies over a longer period. They detected a twofold increase in congenital heart defects associated with Zofran during the first trimester of pregnancy.

Another study, done by Sloan epidemiology unit at the Centers of Disease Control and Prevention, found a “2-fold increased risk for cleft palate associated with ondansetron taken…in the first trimester of pregnancy.”

A recent study by Dr. Gideon Koren published in the December 2014 issue of American Journal of Obstetrics and Gynecology highlights the risks of pregnant women taking Zofran and notes conflicting studies that cannot rule out dangers to a fetus.

The most common types of birth defects that can potentially come from Zofran include:

  • Musculoskeletal anomalies
  • Mouth deformities such as cleft palate
  • Heart defects

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Zofran: The History

On January 4, 1991 the FDA approved Zofran for chemotherapy-related nausea and vomiting. In March of 1999, the FDA issued a warning letter to GlaxoWellcome regarding its marketing of Zofran. According to that letter, GlaxoWellcome failed to warn consumers about Zofran’s adverse side effects while touting its effectiveness. The FDA approved a generic form of Zofran in December of 2006.

In July 2012, GSK resolved several criminal and civil complaints brought against it by the U.S.  Federal government. According to a press release published by the Department of Justice (DOJ), among other things, GSK resolved

“…allegations that it promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent, and Valtrex. The United States alleges that this conduct cause false claims to be submitted to federal health care programs.

GSK has agreed to pay $1.043 billion relating to false claims from this alleged conduct.”

To read the complete DOJ press release, click here.

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Protect Your Rights

Ashcraft & Gerel is investigating claims and potential lawsuits against Zofran’s manufacturer. If you or someone you know has a child with birth defects linked to taking Zofran, please contact us online today or call 800-829-7037. All consultations with a lawyer are completely free and confidential.