Off-Label Drug Use Risks

When a doctor prescribes an FDA-approved drug for something other than what the drug was originally intended, it is called off-label drug use. Doctors may suggest using medications for different conditions for many reasons, such as the drugs intended to treat your condition haven’t worked, or maybe a drug hasn’t been invented for what you need. Doctors can prescribe off-label drugs for treatment, and there are risks that patients need to be aware of before they agree to fill the prescription. But, the doctor also has a duty to make sure they will not cause adverse effects. It’s important to remember that medicine is a practice. The desire to find solutions to unique problems can lead to helpful innovation, but it can also be harmful. Here’s a look at the risks and liabilities involved when a doctor prescribes a drug for off-label use.

Risks of Taking a Prescription for Off-Label Uses

Off-label drug use is fairly common practice, but it can have harmful effects when proper care isn’t taken ahead of time. For example, Zofran was approved by the FDA to remedy nausea in chemotherapy patients. The drug company then began marketing Zofran to pregnant women for morning sickness. Because it wasn’t approved for this use, doctors began to prescribe it off-label to pregnant women. But later, it was found that Zofran could cause birth defects. The drug had never been tested on pregnant women for the purpose of treating morning sickness, so there was no data to support or negate the use of the drug in pregnant women.

There were many mistakes in this case. The drug company was ultimately found liable because they were promoting the off-label use of a product even though it had never been tested on humans for morning sickness. However, the doctors also share some of the responsibility. It is the responsibility of the health care provider to use sound research and evidence in order to act in the best interest of the patient. In this case, many doctors were swayed by marketing materials that they should have realized had no scientific grounding.

The FDA recommends asking your doctor some key questions before agreeing to off-label drug use, including:

  • Why does the doctor think this drug will help better than an approved one?
  • What studies have been done to support using the medicine to treat your condition?
  • What is the drug approved for?
  • Will your health insurance cover using this medicine to treat your condition?

How Common is Off-Label Drug Use in Medicine?

Nearly 75% of drugs prescribed to children are off-label, because most research conducted and medicine approved by the FDA is for adults. In order to treat children’s diseases and conditions it’s common to prescribe off-label drugs, but parents must still ask all the essential questions we’ve discussed. A similar situation is true for cancer patients. Many treatments for cancer patients require experimentation with medications through off-label drug usage.

There have been cases where off-label drug use causes negative side effects after mixing with other medications the patient is already on. The doctor is responsible for obtaining medication history then also taking that into consideration before prescribing off-label medicines and making sure the patient is aware if proper research hasn’t been done on people taking similar medications.

Off-Label Dosing or Administration of Medicine

Off-label drug use is not only the use of drug for different reasons than it was created. It is also when the approved dosage is adjusted, or when the drug is given in a different way, like dissolved into food rather than taken by a capsule. This widens the room for error even more.

There are always risks when using off-label drugs. No matter how much your doctor knows about the drug, it still has not been approved by the FDA for this use, meaning testing and clinical trials might not have examined certain symptoms or side effects. If you and/or your doctor were misinformed or not told the truth by the pharmaceutical company, the liability can get more complicated.

All types of prescribed medications should be well-researched by your doctor, but this is especially true with off-label drug use. This method of treatment is popular and allows for some patients to return to health faster, but it leaves room for risk which should never be taken lightly. If you or someone you love has experienced negative consequences as the result of an off-label drug use prescription, the attorneys at CFCL want to help you move forward in life with peace of mind. From fighting for you in court to helping research and document your case, we’re among the most successful medical malpractice and products liability attorneys in both Indianapolis and greater Indiana. Contact us today for a free consultation.