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Why Are Some Drugs Prescribed Off-Label?

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Frieda Wiley, PharmD - Blogs

The world of medications can be very confusing: there are hundreds of drugs, and many of them come in different names (brand vs generics), various strengths, and multiple ways you could take them (pills, tablets, syrups, etc.). To complicate matters even more, some drugs are sometimes prescribed for uses other than what the FDA has approved—a practice we medical folks call “off-label prescribing.” This can be very confusing for patients—especially if you are familiar with a drug being used for a specific purpose.

If you read medication guides (the printed handouts of drug information you receive when you pick up your prescription), you might be surprised if it does not mention the condition that your doctor prescribed it for.

Before you start to worry, first understand that off-labeling prescribing is fairly common. In fact, between 10-20 percent of all prescriptions written in the United States are for off-label indications. That is as many as 1 in every 5 prescriptions. It is also completely legal to do so. According to the American Medical Association, once the FDA approves a drug for use in the United States, it may be used for any indication. However, this doesn’t mean your doctor is experimenting on you by prescribing you a drug off-label.

One reason doctors prescribe medications for off-label use is that the drug approval process is typically a very long, difficult process that can take up to 20 years from start to finish. Drug manufacturers must conduct clinical trials to evaluate the safety and effectiveness of their drugs. Even after having completed these tests, it sometimes takes the FDA a while to approve new drugs or new indications for old drugs—even if the manufacturer had data showing benefit for another indication for a while. Sometimes, the medical community moves a little faster than the science, and off-label prescribing is an example of this.  

Also, off-label prescribing can be very effective in treating some conditions for which no drugs have been FDA-approved or limited treatment options exist. Doctors may prescribe a drug off-label because the way the drug works benefits another condition they are treating. This is what many doctors are doing now in response to COVID-19. As you’ve probably heard, several medications used for other conditions are being studied to see if they are effective against virus. These include hydroxychloroquine (Plaquenil), a drug the FDA has previously approved to treat malaria, rheumatoid arthritis, and lupus and the antibiotic azithromycin used to treat infections caused by bacteria such as community-acquired pneumonia, acute COPD-related infections, and acute sinus infections.

In another example, if you have stage fright or a fear of public speaking, your doctor might prescribe a drug called propranolol. Propranolol is not approved for anxiety, but it is approved for high blood pressure. It lowers high blood pressure by slowing the heart rate. And its ability to keep your heart from racing is exactly why it tends to help people manage their performance anxiety. In fact, doctors have used propranolol for anxiety since the 1960’s.

Sometimes, doctors prescribe an off-label drug for its side effects. For example, the drug quetiapine (Seroquel) is FDA-approved for schizophrenia and certain bipolar disorders, but because the drug causes extreme drowsiness, doctors sometimes prescribe the drug to help folks get a good night’s sleep.

However, not all off-label prescribing is effective.

Perhaps the most famous—or infamous—example of off-label prescribing is gabapentin (Neurontin). Originally approved in the early 1990’s, gabapentin is indicated for add-on therapy for seizures or to treat herpes-related pain lasting longer than 3 months. However, it has been used for numerous other indications beyond what the FDA originally approved. Among these uses are nerve pain caused by diabetes (diabetic neuropathy), fibromyalgia, sciatica, alcohol withdrawal, and lower back pain—just to name a few. In fact, its frequent prescribing for many other conditions has made headlines in recent years—often because of the lack of solid data or conclusive evidence supporting these off-label uses.

The frequent prescribing of gabapentin in these cases has garnered some controversy in the medical community. Some folks are concerned that patients may not be getting safe and effective treatment. However, this drug is probably an extreme example of ineffective off-label prescribing.

As a rule of thumb, consider asking your doctor about your new prescription before you leave the office. It also wouldn’t hurt to give the medication guide that comes with your prescription a quick read—not only to better familiarize yourself with your new medication overall, but also to make sure you understand why you are taking it. But if you have questions or concerns, a nice chat with your doctor (or pharmacist) can help put your mind at ease.

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About the Author
Frieda Wiley, PharmD, RPh

Frieda Wiley, PharmD, RPh, is a clinical pharmacist, contract medical writer, and consultant. She has numerous publications to her credit, including O! The Oprah Magazine,Arthritis Today, US News & World Report, Everyday Health, and Costco Connection. To read more about Frieda, visit her website or follow her on Twitter.

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