The prescription of a drug is considered “off-label” when it is used in a way different than what is described on the U.S. Food and Drug Administration-approved drug label. According to the American Cancer Society, this could mean the drug is being used for a different disease or medical condition, or given in a different dosage than initially approved. Off-label prescriptions are not considered illegal in the U.S. and are not regulated by the FDA either.
Off-label drug use is actually a fairly common practice among doctors, one that most patients are not aware of. When a person goes to the doctor for an ailment, he or she usually trusts that the physician is prescribing a medication that was approved to treat the general condition. However, Consumer Reports found that about one in five U.S. prescriptions are given for a use other than the one approved by the FDA.
Doctors have many reasons for issuing patients off-label drugs, such as studies done supporting a drug’s use for other purposes or a lack of other options for treating a certain condition. Physicians only prescribe these drugs when they believe them to be in a patient’s best interest, but sometimes doctors don’t have all the facts. A 2009 survey reported 41 percent of physicians believed at least one drug that had little or no supporting evidence in the survey was FDA-approved. The doctors were presented with 14 drugs that varied in FDA approval and evidence of effectiveness.
Potential Risks of Zofran Off-Label Use
Sometimes doctors will prescribe a drug off-label because there has been research and studies indicating that the medication could be beneficial for other uses. However, other times there is little to no evidence at all that these off-label drugs will have any effect on a patient’s ailment. If it happens that the patient does not see any results from the medication, then not only has the person wasted money on an unhelpful treatment, but the patient has also been put at risk for adverse side effects related to that medicine.
Another hazard of off-label prescriptions is that drug manufacturers will start to market the medications for other uses besides the ones approved by the FDA, even though this is illegal. A major instance of this was when the company GlaxcoSmithKline had to pay $3 billion for the unlawful promotion of prescription drugs and other criminal allegations in 2012. One of the drugs the company mismarketed was Zofran, which has been linked to severe birth defects after women used the medication while pregnant.
Zofran Use by Pregnant Women
Zofran, also known as ondansetron, was approved by the FDA in 1991 to treat nausea and vomiting in chemotherapy and surgery patients. The drug works by suppressing serotonin, a neurotransmitter that interacts with gut nerves to determine pain and nausea; it can also induce vomiting. Although this drug was initially intended for chemotherapy and surgery patients, doctors eventually started prescribing this medication off-label to pregnant women who were experiencing severe morning sickness as a way to suppress their upset stomachs. Since the medication was not FDA-approved for this use, however, there was no way of knowing what effects the drug would have on expecting mothers or their children.
Common Zofran side effects include:
- Shortness of breath
Other, more severe, side effects have been linked to the use of Zofran in pregnant women. Studies have found an association between the drug use and an increased risk of birth defects, such as heart damage, kidney problems, cleft lip or palate and club foot. Many mothers did not realize when they were taking the medication that it was not approved by the FDA to prevent morning sickness and were greatly agitated when they discovered its use could be linked to birth defects.
Have You Taken Zofran While Pregnant?
After experiencing the problems associated with birth defects, such as life-long health issues and multiple corrective surgeries, many families are distressed and facing heavy financial burdens. Since people have learned that the use of Zofran may have caused a child’s birth defect, many have filed birth defect claims against GSK for putting their children at risk. If you or a loved one took Zofran during pregnancy and had a child who was born with a birth defect, you may be entitled to compensation. Speak with an attorney to find out what your next step should be when pursuing a Zofran claim.
1. “Off-label Drug Use: What Is Off-label Drug Use?” American Cancer Society. March 17, 2015. Accessed July 22, 2015.
2. “‘Off-Label’ Drug Use.” Consumer Reports. 2007. Accessed July 22, 2015.
3. Chen, Donna, Matthew Wynia, and Rachel Moloney. “U.S. Physician Knowledge of the FDA-approved Indications and Evidence Base for Commonly Prescribed Drugs: Results of a National Survey†.” Pharmacoepidemiology and Drug Safety. August 9, 2009. Accessed July 22, 2011.
Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.