ZOFRAN Lawsuits Over Infant Injuries

by Gabriel F Zambrano


ZOFRAN (ONDANSETRON) is an anti-rapy and surgery. Simply stated, it is believed to work by blocking serotonin a natural substance that is linked to nausea and vomiting.


A recent report in The American Journal of Obstetrics & Gynecology, December 2014, “Treating Morning Sickness in the United States – Changes in Prescribing are Needed“, Dr. Gideon Koren, noted that the use of monthly prescriptions for ZOFRAN (ONDANSETRON) for nausea and vomiting in pregnancy have gone from 50,000 monthly in 2008 to 1110, 000 monthly in 2013. The drug is not approved for such use by the U.S. Food & Drug Administration (FDA). Such is use is known as “off label” and although common, the pharmaceutical industry is not permitted or encouraged by law to promote such “off label use”.


In fact, Dr. Koren notes that 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy, in the United States, are not classified as safe in pregnancy by the U.S. Food & Drug Administration. Similarly, they are not labeled for use in pregnancy, nor indicated for nausea and vomiting in pregnancy. He surmises that about 1 Million women are exposed to off label use of ZOFRAN (ONDANSETRON) out of 4 Million pregnancies. As a result, the increased use in pregnancy raises questions about “off label” use and promotion by both prescribers and the manufacturer. Dr. Koren further questions the use of non-approved drugs in light of an existing combination (doxylamine and pyridoxine) for nausea and vomiting in pregnancy symptoms. Dr. Koren’s commentary is insightful but he is a paid consultant for a manufacturer that has FDA approval for their drug, DICLEGIS, being used for nausea and vomiting in pregnancy symptoms. We point this out in advance of any critics pointing it out.

Zofran Fetal Side Effect Safety Signals

Zofran Cleft Palate or Cleft Lip

Multiple studies evaluating the safety of unborn infants exposed to ZOFRAN (ONDANSETRON) have arguably proven inconclusive in their results or were not designed to fully explore risks during early pregnancy. However, at least one study by the Sloan epidemiology unit and the Centers of Disease Control and Prevention (CDC) has reported a 2-fold increased risk for cleft palate where ZOFRAN (ONDANSETRON) was taken in the first trimester of pregnancy. (See Anderka, M., Mitchell, A. A., Louik, C., Werler, M. M., Hernández-Diaz, S., Rasmussen, S. A. and the National Birth Defects Prevention Study (2012), Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Research Part A: Clinical and Molecular Teratology, 94: 22–30. doi: 10.1002/bdra.22865.) Safety signals and red flags prompt calls for further evaluation and caution appears warranted. This is particularly true given the increased use in the context of pregnancy which is not FDA approved and off label.

What is Cleft Palate or Cleft Lip?

Cleft palate and cleft lip are facial malformations that occur early in pregnancy.WebMD reports that it affects 1 in 700 Babies annually and is the 4th most common birth defect in the United States. Problems associated with this diagnosis include:

  • Problems Eating because food can pass from the mouth through the nose.
  • Hearing Loss or Ear Infections as a result of increased risk of fluid build up in the middle ear.
  • Development Problems in Speech because voices do not carry well or difficulty understanding and communicating.
  • Dental problems because of displaced, missing or malformed teeth, as well as the potential for higher than average cavities.

Risks and complications presented in newborns from the use of ZOFRAN (ONDANSETRON) have also raised awareness of risks to expecting mothers.

Zofran Maternal Side Effect Safety Signals

In 2011, The FDA issued related warnings to physicians and patients as illustrated below. Here is a link to the FDA Drug Safety Communication: Abnormal Heart Rhythms May Be Associated with Use of Zofran and their 2012 Update FDA Drug Safety Communication: New Information Regarding QT Prolongation with Zofran


Absent from any current FDA Safety Communication is a recognition or discussion about “off label” use and the risk of birth defects. In part because you simply are not supposed to use things “off label”, and in part perhaps because it has not fully surfaced as a cause for alarm.

Zofran Side Effects Reported in Canada

In the United States, adverse events from side effects are self-reported or voluntarily reported by physicians. Consumers are not trained in the value of reporting for the sake of monitoring and alerting public health authorities of a problem. This voluntary system is imperfect and problems in other countries may or may not prompt investigation in the United States.

On June 25, 2014, in “Off-Label” Use of Anit-Nausea Drugs Blamed for Birth Defects“, Dr. Koren discussed above, was featured by Torstar News Service, as he questioned the use of ZOFRAN (ONDANSETRON) in Canada for many of the reasons discussed above. Most consumers in the United States are not reading Canadian reports about prescription drug use and likely have not seen or heard FDA Safety Communications directed at healthcare providers and prescribers. Whether the FDA will undertake any action or investigate the rise in off label prescriptions is unclear at this time. Yet is it clear, that consumers should begin to question the use of ZOFRAN (ONDANSETRON) very carefully in light of the information above.

Our office is investigating ZOFRAN (ONDANSETRON) cleft palate, cleft lip and side effect cases. Please call (954) 524-2820 for more information or e-mail [email protected]