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By Melissa Tennen, HealthAtoZ writer
Your doctor has prescribed a drug you've never tried before. You read the materials that come with the medication, which say it treats a disease that is completely different from yours. Why did the doctor give you this drug? Is it safe?
This is called off-label use, which often means that the drug has been approved by the Food and Drug Administration (FDA) for a certain disease, but not for yours. Before a drug can be sold, it has to go through a detailed and long testing process to make sure it's safe and effective. A drug is then approved for a specific disease.
Once the drug gets on market, the FDA cannot tell doctors what to do with that medication. Doctors may choose to use a drug that is not listed by the FDA for a certain condition. This is off-label use. Doctors will not endanger your health or be reckless in what they give you. Remember, your doctor is there to help you.
Your doctor bases this treatment decision on a network of knowledge. Before giving you a drug off label, doctors look at their own experiences with the medication, what their colleagues have reported, studies in scientific journals and presentations at professional meetings. Prescribing any drug is not taken lightly.
Off-label prescribing is very common. Nearly half of all prescriptions today are written for uses other than the ones for which the drug was approved. Manufacturers can give information on studies to doctors, but the FDA does not allow these drug companies to advertise unapproved uses.
Why doesn't the drug company just apply for other uses? It's simple. It's economics. Off-label use is legal, so pharmaceutical companies don't have much reason to pursue the costly and long process of getting FDA approval. If the manufacturer doesn't foresee huge profits in getting approval for another use, the company doesn't pursue it.
Off-label prescribing can be life-saving. Some chemotherapy and AIDS medications are off-label. Off-labeling can be for:
- A disease other than the one for which it's approved.
- A different dose, duration or frequency than what the label says.
- Treating a child when the drug is approved for adults.
Ask your doctor these questions about your medication:
- How will this help me?
- What are the risks and side effects?
- How long will it be before I see results?
- What happens if I take too much?
- What should I do if I miss a dose?
- Are there any foods, medications or supplements that I should not take with this drug?
This article was reviewed and updated June 2007.
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