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What You Need to Know If Your Doctor Gives You an Off-Label Drug Prescription

When you go to the doctor because you are not feeling well, you may assume that the prescription he gives you is for the medical condition he diagnosed and that it has been approved by the U.S. Food and Drug Administration (FDA). Unfortunately, this is not always true. Doctors commonly write off-label prescriptions—prescriptions for medications being used in a way not specified in the FDA-approved packaging label. For example, you could receive an antidepressant to curb your hot flashes, a blood pressure medicine to help with stage fright, or an antipsychotic drug to treat your insomnia. This practice can have benefits and disadvantages for patients.

Three Dangers of Off-Label Medications

Patients often do not realize they are being given an off-label prescription, and doctors are not required to tell patients they are doing so. However, some of the dangers to be aware of that could be considered medical malpractice include:

  • Medicines are being prescribed for disorders without any medical evidence that they help the problem.
  • Doctors prescribe off-label medications without realizing that they are not intended for this use and have not been approved by the FDA for this medical condition.
  • Patients can have unwanted and dangerous side effects from the medication, such as permanent damage to their heart valves or other vital organs.

When Off-Label Prescriptions Can Help Patients

Sometimes taking an off-label prescription can be beneficial. For example, if a person has a rare disease or cancer and has exhausted all approved medications, it could make sense to try an off-label drug. Cancer treatments using chemotherapy often involve the use of off-label drugs when it has been found that a type of chemotherapy approved for one cancer actually helps another form of this disease.

If another use emerges for an approved drug, doctors may begin prescribing it off-label to not have to wait through the lengthy approval process. In addition, they may be more likely to do so if the practice is supported by good medical data. For example, topiramate, an anti-seizure drug, has been found to also treat alcohol dependence and is frequently prescribed for this condition. 

Steps You Should Take

You need to protect yourself from the dangers of off-label drugs by educating yourself on your prescriptions. You should also do the following:

  • Ask your doctor if he is prescribing an off-label medication. If he does not know, ask your pharmacist.
  • Check for yourself on the DailyMed website or another reputable website.
  • If the prescription is off-label, discuss the medical findings supporting its use for your condition with your doctor.
  • Check with your health insurance company to be certain the prescription is an approved drug for your medical condition.

If your doctor prescribed an off-label medication and you suffered injuries as a result, you could have a claim of medical malpractice against your doctor. Call me at 888.716.8021 for a FREE consultation to learn about your legal options.