Off-label drug use common, but patients may not know they're taking them, study finds

August 6, 2012

Many people have probably heard of off-label drug use, but they may not know when that applies to prescriptions they are taking, a Mayo Clinic analysis found. Off-label drug use occurs when a physician prescribes medication to treat a condition before that use has been approved by the Food and Drug Administration. In a newly published article in Mayo Clinic Proceedings, researchers pose and answer 10 questions about off-label drug use.

"Since the does not regulate the practice of medicine, off-label has become very common," says lead author Christopher Wittich, M.D., internal medicine physician at Mayo Clinic. " and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one."

Some highlights from the article:

  • Off-label drug use is common. Within a group of commonly used medications, roughly 1 in 5 prescriptions were for an off-label use, a 2006 report found. Another study found that about 79 percent of children discharged from were taking at least one off-label medication.
  • Patients may not know when drugs they have been prescribed are being used off-label. No court decision has required that physicians must disclose, through informed consent, the off-label use of a drug, the authors say. The FDA makes clear that it doesn't regulate the practice of medicine and that the federal Food, Drug, and Cosmetic Act of 1938 doesn't make physicians liable for off-label drug use, they note.
  • Off-label drug use can become the predominant treatment for a condition. For example, some antidepressants are not approved by the FDA as a treatment for neuropathic pain, yet some drugs in this class are considered a first-line .
  • Examples of widely practiced off-label drug use include morphine, used extensively to treat pain in hospitalized . Many inhaled bronchodilators, , anticonvulsants, and proton pump inhibitors also are used in children without formal FDA approval.
  • Obtaining new FDA approval for a medication can be costly and time-consuming. To add additional indications for an already approved medication requires a supplemental drug application; if eventually approved, revenue from it may not offset the expense and effort for obtaining approval.
  • Generic medications may not have the requisite funding resources needed to pursue FDA-approval studies. For these financial reasons, drug proprietors may never seek FDA approval for a new drug indication.
  • Pharmaceutical manufacturers are not allowed to promote off-label uses of medications. However, they can respond to unsolicited questions from health care providers and distribute peer-reviewed publications about off-label use. Just this year, GlaxoSmithKline agreed to pay a record $3 billion to settle a Justice Department case involving alleged off-label drug use marketing, and Merck Sharp & Dohme was fined $322 million over its alleged promotion of the painkiller Vioxx for an off-label use.

Explore further: Research suggests off-label prescribing of medications is common

Related Stories

Research suggests off-label prescribing of medications is common

April 16, 2012
A study evaluating off-label prescribing of medications in a primary care network in Canada suggests the practice is common, although it varies by medication, patient and physician characteristics, according to a report published ...

Recommended for you

Cancer drugs' high prices not justified by cost of development, study contends

September 12, 2017
(HealthDay)— Excusing the sky-high price tags of many new cancer treatments, pharmaceutical companies often blame high research and development (R&D) costs.

Non-psychotropic cannabinoids show promise for pain relief

September 4, 2017
Some cancers love bone. They thrive in its nutrient-rich environment while gnawing away at the very substrate that sustains them, all the while releasing inflammatory substances that cause pain—pain so severe that opioids ...

Fentanyl drives rise in opioid-linked deaths in U.S.

August 31, 2017
(HealthDay)—Fentanyl, a synthetic narcotic, is a key player in America's continuing epidemic of opioid-related overdose deaths, two new studies report.

Eating triggers endorphin release in the brain

August 28, 2017
Finnish researchers have revealed how eating stimulates brain's endogenous opioid system to signal pleasure and satiety.

Cholesterol-lowering drugs may fight infectious disease

August 21, 2017
That statin you've been taking to lower your risk of heart attack or stroke may one day pull double duty, providing protection against a whole host of infectious diseases, including typhoid fever, chlamydia, and malaria.

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.