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What’s an Off-Label Prescription?

What’s an Off-Label Prescription?

When your doctor writes you a prescription, there’s a chance that the medication they’ve prescribed you may not be approved by the FDA for your specific need.

While this may sound alarming, it’s generally not something to worry about.

Off-label prescribing is both legal and very common. In fact, one in five of all prescriptions written is off-label.

Here we’ll walk through what off-label prescribing is and how it works.

What is off-label prescribing?

The FDA (Food and Drug Administration) is responsible for approving all medications that can be marketed in the U.S.

When a drug is considered “FDA Approved”, it means it’s considered to be safe and effective for one specific condition or symptom.

Off-label prescribing happens when your doctor prescribes you a medication to be used in a way that’s different than what the FDA has approved it for.

It’s important to point out that off-label drug use is not considered experimental. Once the FDA has approved a medication for a condition or symptom, it can legally be prescribed by doctors to treat other conditions.

What are some examples of off-label prescriptions?

Examples of off-label prescriptions can be found in nearly every area of medicine.

One of the most common examples is the use of birth control to treat acne. For years, doctors have been prescribing oral contraceptives to help treat acne and it’s widely considered an effective option. But even so, only a handful of birth control brands have actually received official approval from the FDA to be used to treat acne on-label.

Another common example of off-label prescribing is in chemotherapy. These drugs are often only approved for one type of cancer; however, doctors have found that in many cases one medication can help treat several different types of cancer.

Though no longer the case, Lasik eye surgery was once considered an off-label practice. When the technology was first being used, the type of equipment used during surgery was off-label. In 1999, the FDA officially approved the surgery and equipment as on-label.

Beta-blockers have been approved by the FDA to treat the symptoms of certain blood pressure and heart conditions. However, they have also been commonly prescribed for decades by doctors to lessen the physical symptoms caused by performance anxiety.

Off-label prescribing is legal.

The FDA is responsible for monitoring which medical conditions and symptoms prescriptions can be marketed for. They are not responsible for monitoring how doctors can prescribe medication.

As long as a doctor is able to show that a prescription is evidence-based and medically safe for a patient, they are legally able to write a prescription for it.

Is off-label prescribing safe?

Off-label prescribing is largely considered a safe practice. In fact, there are safeguards in place that require a doctor to prove certain criteria is being met to prove that a prescription is medically necessary.

And in fact, it’s seen as largely beneficial to patients. Off-label prescribing allows doctors a way to provide additional treatment options, which can be especially important when other FDA-approved medications haven’t been effective for a patient.

In fact, it’s not uncommon for off-label uses to eventually be approved by the FDA and converted to an on-label practice.

Is a doctor required to tell you if a prescription is off-label?

Doctors are not legally required to tell patients that a prescription they’ve written is off-label. However, many doctors consider it best practice to share this information with their patients as a way to keep them included in their own medical decisions.

You can always ask a doctor if your prescriptions are considered off-label.

If off-label prescribing is so common, why doesn’t the FDA just convert all off-label uses to on-label?

Getting FDA approval for a medication takes both a lot of time and a lot of money, even for medications that have already been approved for other uses.

This can be especially challenging for generic medications whose costs are lower and don’t have the funding necessary for this process.

Interested in learning if beta-blockers can help you with performance anxiety? Start an online visit today with one of our board-certified doctors to learn whether or not they’re the right option for you.

Reviewed by Dr. Alex Dimitriu

Dr. Alex Dimitriu is a Stanford-trained physician with dual board certification in psychiatry and sleep medicine. The included content is not intended to replace medical advice. Always be sure to discuss any prescription medications with your doctor.