Zofran has been on the market for more than 20 years, and was originally approved in the United States by the FDA in 1992, mainly used by cancer victims. Zofran was approved to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. It is in a class of drugs known as 5-HT3 receptor antagonists that work by blocking the action of serotonin, a natural chemical produced by the human body that can cause nausea and vomiting. Zofran has also gained popularity as an unapproved, “off-label” treatment for extreme morning sickness. Zofran is not FDA-approved for treating morning sickness during pregnancy. Zofran isn’t created specifically for nausea and vomiting and using Zofran for nausea and vomiting in pregnant women has not been tested. The most common types of birth defects that can potentially come from Zofran used during pregnancy include:
- Musculoskeletal anomalies
- Mouth deformities
- Heart defects
Along with the risks of birth defects in their infants, other side effects that directly affect the mother include:
- Rashes, hives, and itching
- Shortness of breath
- Body swelling
- Irregular heartbeat
- Difficulties in breathing and swallowing
It’s important to note that despite its potential risks, the FDA has not stopped Zofran from being prescribed. However, in 2012, the Justice Department reached a $3 billion settlement with GlaxoSmithKline after the drug-maker was accused of promoting Zofran as well as other medications for off-label uses. Off-label use is the practice of prescribing pharmaceutical drugs for an indication that has not been approved by the FDA, or in an unapproved age group, unapproved dosage, or unapproved form of administration. Off-label use is a legal practice, but physicians are obligated to warn patients of potential side effects.
As a result of potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System (FAERS), in early 2013, the FDA added Zofran to its watch list. The appearance of a drug on this list means that FDA has identified a potential safety issue that it intends to investigate further.
Andrus Wagstaff PC is investigating potential claims in regards to birth defects as a result of taking Zofran during pregnancy. Please contact us using the online form so that we may better evaluate your claim.