Like Ozempic For Weight Loss, Off-Label Use is Common. Here's What That Means.

What It Means When Your Doctor Prescribes Something 'Off-Label' 

With all the noise around Ozempic for weight loss, it's easy to forget that the medication is actually intended to manage diabetes. That's because doctors are prescribing it off-label, meaning you're given a drug that's been FDA-approved to treat a condition different from your own — and it's a pretty common thing. 

How and why this happens 

"A physician can prescribe any drug for anything they want to," says Adriane Fugh-Berman, MD, a pharmacology and physiology professor at Georgetown University Medical Center. But it's complicated. "Some off-label use is proven and good, but there's a lot of off-label promotion of drugs that either haven't been proven to help a particular condition or even has been disproven to help a particular condition," she adds.

Nevertheless, in some cases, off-label prescriptions can be necessary.

• Pregnancy. If a medication isn't specifically tested in certain groups, they often aren't approved for these patients either. For example, depression is common during pregnancy, but antidepressants aren't explicitly approved for pregnant people. With off-label prescribing, you and your doctor could calculate whether the benefits outweigh the potential risks.

• Rare diseases. An estimated 95% of rare diseases don't have any FDA-approved therapies. Off-label prescribing allows doctors more treatment options for these patients, and one estimate reports up to 90% of prescriptions for rare diseases are off-label.

• Science-backed uses. Research supports off-label use in some cases, but drugmakers may not seek approval. For example, many studies show that misoprostol on its own is safe and effective for early-term abortions, but it's not FDA-approved for this purpose.

Despite the pros, there are some serious cons. Off-label prescriptions may carry a greater risk of unwanted or harmful side effects. According to a 2008 estimate, about three-quarters of off-label prescriptions aren't backed by adequate scientific evidence, and the lack of research has caused real harm. In the '90s, "fen-phen" drugs were prescribed off-label to millions of people for weight loss, but were later linked to heart damage in some patients.

Your move

Become an expert on your meds. While doctors may prescribe many drugs, you only have to focus on those you’re prescribed. Thoroughly research your meds and become familiar with their approved uses (try the DailyMed database). 

Ask your doctor for context. If they prescribed an off-label drug, consider asking: Is this common practice? Are there studies that back up this use? What are the potential risks?

Talk to your pharmacist. Pharmacists often know much more about specific medications than doctors, says Fugh-Berman.

We asked you to vote on a question you’d like answered. The winner was:

Why does a lot of noise overstimulate me?

FEATURED EXPERT:

Aaron N. Pearlman, MD

An ear, nose, and throat specialist at Weill Cornell Medicine

“Noise is integrally related to our emotional state and [it] can be calming or unsettling. Too much noise can be distracting and keep a person from focusing. Some people find some noises so unpleasant that they can affect their mood.

If noise overstimulates you, consider trying to create a quieter environment where you can relax or take breaks. Noise-canceling headsets might be helpful, or wearing earplugs in loud environments to reduce your emotional and physical response to sound. If the sound seems loud to you or [is] hurting your ears, then you should take precautions. If it’s too loud for too long, it can damage your hearing. [If you can], turn it down a bit to be safe.” 

This interview has been edited and condensed for clarity. You can read the full story on sensory overload here.

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We're here to fact-check health trends, wellness assumptions, and myths. Such as:

Are full-body MRI scans worth the cost? 

Well, actually, they may do more harm than good. 

Kim Kardashian recently took to Instagram to share her experience with Prenuvo — a company that offers full-body MRI scans that cost between $1,000 to $2,500 and can detect more than 500 conditions, according to the company's website. It's easy to see the appeal — if something is happening inside your body, aren't you better off knowing? 

Not always, according to Otis Brawley, MD, an oncology and epidemiology professor at Johns Hopkins University. "The problem is that MRI is really good at finding things, to the extent that it finds a lot of things that don't matter," he explains. 

These scans can turn up false positives — abnormalities that may look like cancer or another serious condition but turn out to be harmless in further tests. They're also prone to overdiagnoses of cancer in organs including the kidneys, liver, and breasts, and "we have no studies to show that they save lives," says Brawley.

This can all be physically and emotionally damaging and potentially lead to unnecessary tests, treatments, and anxiety along the way. "If you start sticking needles into enough people and doing biopsies, you collapse lungs, you hit blood vessels … and people get harmed," says Brawley. 

Medical institutions, including the American College of Radiology, don’t recommend preventative full-body scans because of the lack of evidence showing they actually benefit patients. Instead, consider following screening guidelines, such as those from the American Cancer Society. The question is which detection methods prevent the most deaths — not those that find the most disease, says Brawley. Ultimately, it’s up to you to decide if the latest trend is worth your money.

"Screen apnea"

— When you stop breathing while staring at screens like checking your email or getting a text. In, out, in, out.