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What Are Off-Label Prescription Drugs and Why Should I Care?

Last Updated on February 26, 2018 by Inspire Malibu

Here’s an interesting fact that many people are likely unaware of; regardless of what illness the Food and Drug Administration (FDA) approves a medication for, physicians are free to prescribe that same drug for any other condition they deem medically appropriate. This practice, referred to as off-label prescription drug use, is extremely common.

Off-Label Prescription Drugs

“On average,” writes Dr. Gregory Curfman, editor in chief at Harvard Health Publications, “one in five prescriptions are written for an ‘off-label’ use of a drug.”

What Are Common Off-Label Prescription Drugs?

While it might come as a surprise that your doctor may have suggested a medication for a non-FDA approved condition, the practice is widely accepted. In fact, a number of first-line treatment options for certain disorders are off-label. These include medications such as the following:

  • Beta Blockers are FDA approved to lower blood pressure, but are widely prescribed for those dealing with mild anxiety or migraines
  • Tricyclic Antidepressants are approved for treatment of depression and anxiety, but are often prescribed to patients suffering chronic nerve pain, insomnia, Bulimia or irritable bowel syndrome
  • Topamax, which is approved by the FDA for the treatment of migraines and seizures, has gained much off-label attention in the treatment of alcohol dependence

Why Are Drugs Prescribed Off-Label?

According to a journal article titled “Ten Common Questions (and Their Answers) About Off-label Drug Use,” sponsored by Mayo Clinic Proceedings, there are a number of reasons drug makers prefer not to seek additional FDA approval for a medication that’s been proven effective in off-label treatments.

“Obtaining new FDA approval for a medication can be costly and time-consuming,” says the article, adding that “…revenues for the new indication may not offset the expense and effort of obtaining approval.”

Though off-label drug use is common, the FDA prohibits pharmaceutical companies from promoting unapproved uses of their drugs. There is a long history of drug manufacturers exaggerating the efficacy of their products.

“Over the past decade 17 companies paid more than $16 billion in settlements for off-label promotion, according to the American Medical Association, including Pfizer, GlaxoSmithKline and Eli Lilly,” writes Toni Clarke in the Scientific American.

In lieu of promoting their products off-label uses, companies are allowed to provide doctors with data from legitimate clinical trials that have subsequently been published in well established and trusted medical journals.

Pharma reps may also talk about these practices at medical conferences.

The true benefit “off-label” drug use is that patients may get access to medications that will help them even before those medications are specifically approved for their conditions.

More than ever before, it’s important to take as much control over your own health and wellness as possible. With availability to the internet, doing research on different medications, their side effects, FDA approval, “on” and “off” label use is very informative and easy to find.

When visiting your physician, be ready to ask questions about whether or not the medication they’re prescribing is approved for the suggested use and if not, is there good evidence that it’s worked well as an off-label drug.


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