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Ozempic, an injectable diabetes drug manufactured by Novo Nordisk, has recently increased in popularity and has caught the attention of celebrities and the general public alike. Known for its significant weight loss effects, Ozempic and similar products are changing how Americans approach nutrition, exercise, and body image. In addition to these potentially dangerous changes, the popularity of Ozempic exemplifies the potential dangers of off-label usage of drugs, as Ozempic’s intended audience struggles to access the medication due to its boom in popularity.

 

What is Ozempic, and how does it work?

The Food and Drug Administration first approved Ozempic, a drug used to treat diabetes, in 2017. The active ingredient in Ozempic is semaglutide, which lowers blood sugar levels and regulates insulin, making it a crucial ingredient for those with type 2 diabetes. Semaglutide indirectly promotes weight loss as it imitates a naturally occurring hormone called glucagon-like peptide-1 that limits appetite by telling our bodies that we feel full and causes our stomachs to empty at a slower pace. Semaglutide makes patients feel fuller faster, and others have reported that their “food noise,”, or constant thoughts surrounding food, have disappeared after taking the drug.

Ozempic is not the only drug that utilizes semaglutide. In 2021, the FDA approved Wegovy, a drug with a higher dose of semaglutide than Ozempic, to treat obesity. Though Wegovy is not marketed as a diabetes drug like Ozempic, it has seen a similar exponential increase in popularity, with prominent figures like Elon Musk admitting to taking Wegovy for weight loss. In November 2023, the FDA approved Zepbound, another weight management drug that mimics diabetes medication.

 

What are the immediate impacts of Ozempic?

The weight loss effects of Ozempic and similar drugs have led to rampant off-label usage of these drugs. Ozempic is originally intended for those with type 2 diabetes, and though Wegovy is intended for adults with obesity or “excess weight,” these individuals must also satisfy at least one “weight-related condition,” such as high blood pressure, type 2 diabetes, or high cholesterol. Because Ozempic has not been FDA-approved for weight loss purposes, it has not been significantly studied in individuals without diabetes or excess weight. However, when the FDA authorized Wegovy for weight loss, the demand for the drug was so high that some providers had to resort to Ozempic when they could not access Wegovy.

The most discussed side effect of Ozempic is muscle loss because rapid weight loss generally tends to also decrease muscle mass, bone density, and resting metabolic rate. This side effect is so prevalent that companies are catching on—luxury gyms such as Equinox are offering strength training programs specifically designed for people taking these medications, and meal-delivery services like Daily Harvest have created high-protein meal plans for Ozempic users to offset the muscle loss. Even other drug companies, such as Eli Lilly, are in the process of creating treatments that prevent muscle loss, though they deny that this development is in response to the rise of Ozempic. Though there is more research to be done, those taking Ozempic and Wegovy may also experience nausea and dehydration. Though extreme side effects are rare, some patients may experience significant changes in bowel movements.

Though there is not yet enough evidence to know whether these drugs are actually dangerous for people outside of the FDA’s intended audience, experts advise the Ozempic-curious to stay cautious of off-label use. Ozempic and Wegovy are intended to be taken under close medical supervision, and doctors are cautioning against simply ordering the drugs online and trying them out, as many have no idea how these drugs will impact their bodies. Additionally, researchers have not tested the drug in people with lower body weights, so those who are not diabetic and/or do not have a high body weight may experience more significant side effects. There is no way to say without more time to conduct more clinical trials and research.

 

What are the greater, long-term impacts of Ozempic?

A more troubling impact of Ozempic deals with supply and demand: since there has been an exponentially high demand for Ozempic, the supply has dwindled, causing a worldwide shortage of the drug for those who need it. Novo Nordisk, the manufacturer of both Ozempic and Wegovy, has started to ration starter kits of Ozempic in Europe, as both drugs are on the FDA’s official list of drug shortages. In an attempt to hold off the frustrations of those who are eager to get their hands on Ozempic, Novo has recommended that doctors limit adding new patients on Ozempic during the shortage until the supply situation presumably improves in Q1 of 2024.

Ozempic and Wegovy have been in shortage since 2022. Though both drug shortages are serious, the Ozempic shortage presents more serious consequences as it is not just a weight loss drug like Wegovy but also a critical medication for those with type 2 diabetes. According to the FDA, Ozempic is approved to lower blood sugar levels in adults with type 2 diabetes, in addition to lowering the risk of heart attack, stroke, or death. Ozempic is also a more attractive option than Wegovy for those who are seeking to use it for weight loss—it has a lower retail price and is more likely to be covered by insurance compared to Wegovy, which retails for a steep $1500 for a 30-day supply. Though patients with type 2 diabetes currently have alternatives to Ozempic to last them through this shortage, this lack of supply disproportionately burdens them, forcing many to switch their years-long medication routine to replace Ozempic and causing them to travel miles to locate the nearest pharmacy that has Ozempic in stock.

These burdens are not without consequence, either—switching medications can cause the diabetes treatment to be less effective, and even if patients are able to find a pharmacy that has Ozempic, there is no guarantee that it stocks the correct dosage for that patient. For type 2 diabetes patients who are desperate to get back on Ozempic, taking a lower dose might be their only option, which is not ideal because patients might not respond the same way as they did on their regular higher dose. The trouble for those with type 2 diabetes will continue even after Ozempic presumably becomes widely available again—going back on the drug can come with side effects such as nausea and vomiting, starting from square one of getting acclimated to this drug. Both physicians and patients are struggling under this supply chain issue. Still, it is not yet clear when it will be fully resolved, as the FDA has said that sterile injectable medications like Ozempic have a “limited number of production lines” that can make these drugs.

 

What can be done?

The solution to any drug shortage is not simple, as there is no one answer as to why they occur in the first place. However, in the case of Ozempic, it is rather clear that the main cause of the shortage is the boom in demand. Demand is especially difficult to control in this case, as much of the interest and marketing for this drug has occurred on largely unregulated social media platforms. One way to curb this high demand for Ozempic, since it is usually covered by insurance, is to work with insurance companies and physicians to determine why a patient is asking to be prescribed Ozempic. As a preliminary matter, physicians should have an honest conversation with their patients about their motivations for wanting the drug. If they reveal that it is for weight management, the physician should inform the patient that Ozempic is not designed to be a weight loss medication and present alternatives. If the patient has another reason for wanting Ozempic, then the physician should look closely at their medical history to see if they have or are at risk of type 2 diabetes. If not, the physician should work with the patient to devise alternative solutions to fix whatever problem the patient is experiencing. Though this sounds like a simple conversation that already occurs at most doctors’ appointments, determining the individual patient’s risk for diabetes and their motivation to be on Ozempic can be powerful, as Ozempic is only covered by insurance when a doctor prescribes it. Without insurance, it is about $1000, and though there are many who are willing to pay that price for off-label use, the high-ticket cost is sure to curb the demand by a little bit. As for physicians who want to help their patients on their weight loss journey, they can prescribe Wegovy, which is designed for just that. Though the shortages in Wegovy are also well-documented, causing some doctors to spill over into Ozempic, being vigilant about the intended uses of each drug will not only free up the supply for diabetes patients but also caution against the rampant misuse of both drugs.

 

Suggested citation: Allison Kim, Ozempic: A Miracle Drug or the Start of a Public Health Crisis?, Cornell J.L. & Pub. Pol’y, The Issue Spotter (March 6, 2024), http://jlpp.org/blogzine/ozempic-a-miracle-drug-or-the-start-of-a-public-health-crisis.