Is off-label use overused?

In March 2023, I started working at a large retail pharmacy as a technician. Bright-eyed and bushy-tailed, I donned my crisp, blue technician’s uniform complete with my slightly lopsided name tag on my first day. I was excited to begin work at my first paid clinical job, knowing it would leave a bright spot on my physician assistant program application. In my head, I was planning my interview responses to talk about a job I hadn’t even started. My parents were so proud that they told all their friends I was an official member of the health care services community, who was on her way to one day treating her own patients. Unfortunately for them, this is no longer the case. 

I remember walking in on my first day and watching the pharmacist and other technicians pick up phone call after phone call, telling patients that their Mounjaro was on backorder or that their Trulicity was still on the way, despite the patient being out of their medication for an entire two weeks. It was only a couple of weeks until I, too, became a bearer of bad news for many of our regulars. This was due to drug shortages where demand from patients exceeded the supply manufactured and stored.

One technician I talked to who had worked at the pharmacy for more than 15 years said drug backorders were never this common. Career pharmacists, like my coworker, never expected the state of the health care system to get to the point where backorders transpired into an untameable, never-ending problem. There wasn’t an exact reason that explained the supply issues — there could’ve been many: our aging population, our country’s increase in unhealthy lifestyle factors or higher awareness for general health and wellness. Considering these possibilities, there was one trend we all looked to that was causing this shortage — the rise of off-label prescriptions, specifically for weight loss and anxiety. 

The main culprit that caused me to rethink my career trajectory was my disillusionment with health care administration. Though there were other reasons why I didn’t continue my path to becoming a physician assistant, including my inability to stay sane during any chemistry or biology lecture and my feelings of burnout while trying to accumulate as many patient contact hours as I could. I wanted to work in clinical settings because of how fulfilled I felt volunteering in hospitals, and I wanted to pursue psychiatry because of my strong interest in psychology. However, after working this job for more than a year, the interactions I expected to have were not the ones I experienced firsthand.  

Off-label drug use is when a medication is prescribed for a reason that is not approved by the U.S. Food and Drug Administration. This organization ensures drugs are being manufactured, marketed and distributed safely to the public. Once the medication is approved to be prescribed, physicians must exercise sound judgment to prescribe the drug for an unapproved use.  

Some reasons for off-label drug use include using a drug for its unintended side effects because the drug hasn’t been studied in a specific population or the dosage strength of an approved drug is too strong to be widely distributed. A common example is Ozempic, a GLP-1 agonist meant to treat type 2 diabetes, which is increasingly being prescribed for weight loss. In fact, Novo Nordisk now has a weight-loss-specific option called Wegovy, which is made with the same active ingredient as Ozempic. Adderall and some other ADHD medications are also increasingly used to suppress appetite and aid in losing weight.

I shadowed a physician assistant who works in gastroenterology my freshman year, and I remember her rationale behind prescribing Ozempic and other injectable medications for weight loss: Obesity is a chronic condition, just like hypertension and high blood pressure. Therefore, it should be treated like one — with a drug that needs to be administered regularly. 

Ozempic has been and still is in the spotlight for its unintended uses, but it is not the only drug receiving attention in the public eye for its off-label use. Aside from weight loss, patients are also using drugs off label to combat various forms of anxiety. Xanax and Zoloft do exist as popular options, but some alternatives that have been popular since 2016 work more on the body’s response as opposed to altering brain chemistry. A New York Times article published this spring cites beta blockers, which are meant to treat high blood pressure and irregular heart rhythms, as viable medications to help reduce the body’s responses in its flight-or-fight by stopping the effects of adrenaline. According to the New York Times, celebrities like Khloé Kardashian and Robert Downey Jr. have used beta blockers to help mitigate the effects of stage fright and performance anxiety, placing this form of treatment in the public spotlight.

Likewise, singers such as Katy Perry and Shawn Mendes have also been quoted regarding their use of beta blockers to help them maintain composure and focus on their show. By preventing some of the physical symptoms of anxiety — shaking, a rapidly beating heart and sweaty hands — without creating unwanted side effects like brain fog or slurred speech, beta blockers quickly became a trusted solution for singers, comedians, athletes and anyone seeking to remedy their performance anxiety. 

There are also other instances of off-label use for performance obstacles. The use of cognitive stimulants like Adderall has been climbing among medical and law school students to enhance wakefulness during exams, stay engaged during discussions and help them focus for longer periods of time when studying. I do understand and respect that there are prescribed medications necessary to remove mental barriers and improve quality of life, but part of me is wondering where the fine line blurs between off-label use and drug misuse.

As someone who has felt disappointed by the encounters witnessed in patient care, I’m curious about what kind of training is in place to identify and mitigate dependence and overuse. How do we make sure practitioners are not pressured by outside forces like loss of patients or profits so that they can provide quality care they are confident in? 

In a written interview with The Michigan Daily, Dr. James Abelson, the director of the Anxiety Disorders Program at the University of Michigan, shared his perspectives on off-label drug use of beta blockers for anxiety and ADHD medications for exam performance. 

“We use beta blockers with some regularity in our Anxiety Clinic, in very specific clinical circumstances, prescribed by a psychiatrist who is educated in how to optimally use them for presentations or exams,” Abelson wrote. 

In the case of ADHD medications being used to enhance performance, Abelson wrote, “The desire to use stimulants in this way suggests to me that there may be an underlying anxiety problem that is better addressed through other means, or it suggests an underlying vulnerability to overuse, misuse or dependence on substances to manage other issues, which can be dangerous.” 

ADHD medications like Adderall and Vyvanse are classified as controlled substances and Schedule II drugs. This means that their production and distribution are federally regulated by the Drug Enforcement Administration because of their high potential for abuse, misuse and dependence.

Because it is up to the practicing physician to decide whether to prescribe off-label or not, it’s comforting to know that there is special training in place to help health care providers make these important decisions. 

I don’t know what the future of our medical landscape looks like, and how it’s going to shape off-label use of drugs. What I do know is that not all off-label uses are widespread. Whether we are future practitioners, treatment seekers or curious learners, we should be responsible for staying up to date and educated to better protect ourselves and our community.

Statement Columnist Michelle Wu can be reached at michewu@umich.edu.

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