New York.- Ozempic, a drug used to treat diabetes, has recently gained attention as celebrities, a tech mogul and TikTok influencers reported using it to lose weight quickly.
The US Food and Drug Administration (FDA) approved the injectable drug to treat diabetes in 2017; and in 2021, the agency approved a drug with a higher dose of the active ingredient in Ozempic, called semaglutide, to treat obesity under the name Wegovy. Since then, mentions of the drug have spread on the internet. When Elon Musk was asked how he managed to look “fit, ripped and healthy,” he tweeted that he takes Wegovy. Andy Cohen, host of Bravo, posted about the growing popularity of Ozempic. In September, Variety reported that actors and producers are “quietly applauding the drug” on Signal, an encrypted messaging app. On TikTok, the hashtag #Ozempic has been viewed more than 273 million times; users on the one hand express surprise at the weight loss supposedly caused by the drug and share anecdotes about the side effects.
Now, the FDA has identified both Ozempic and Wegovy among dozens of drugs in short supply. A representative for Novo Nordisk, the company that makes the drugs, wrote in a statement that the company is experiencing “intermittent supply disruptions of various doses of Ozempic due to a combination of incredible demand along with other overall global supply constraints.” The representative added that the Wegovy shortage could be resolved soon and that the company is “on track” to make all doses of the drug available by December.
It’s not unusual for doctors to prescribe drugs “off-label” or for a purpose other than their explicit purpose, said Disha Narang, an endocrinologist at Lake Forest Northwestern Medicine Hospital. With increased interest in Ozempic, some doctors believe more people have been looking for ways to take it for weight loss, either by going to a specialist who prescribes it off-label or by going online to get it. Narang herself has seen patients who “have somehow gotten this” and take their medication off-label, she said. (Narang served on an advisory panel for Novo Nordisk, a common practice for experts in the field.)
The doctor is concerned that as it becomes more and more popular, people will associate the drug with “vanity” and not identify it as a crucial drug for diabetic patients.
Here’s what we know about that drug, what it can do, its limitations, and who should take it.
How does Ozempic work?
Both Ozempic and Wegovy are designed to be injected once a week into the stomach, leg, or arm.
Semaglutide lowers blood sugar levels and regulates insulin, which is crucial for people with type 2 diabetes. The drug also mimics a hormone called glucagon-like peptide-1 that we produce naturally in the intestines, limiting the appetite by signaling to the body that we feel full and makes the stomach empty more slowly. As a result, people with obesity and accompanying health problems have lost weight while taking this drug. Patients feel full sooner, said Janice Jin Hwang, chief of the division of endocrinology and metabolism at the University of North Carolina School of Medicine. For those taking the drug, “foods that were very exciting to them are no longer exciting,” she said. The drug has not been studied enough among people without diabetes or who are overweight.
The drug may also reduce the risk of cardiovascular disease for patients with diabetes, said Robert Gabbay, chief scientific and medical officer for the American Diabetes Association.
The FDA has not approved Ozempic for weight loss, said Andrew Kraftson, an associate professor of clinical practice in the division of metabolism, endocrinology and diabetes at Michigan Medicine. But, he explained, after the FDA approved Wegovy for use in weight loss, demand increased so much that some medical professionals turned to Ozempic when they couldn’t get hold of Wegovy.
Just as some people are prescribed drugs to treat high blood pressure or high cholesterol indefinitely, some patients with obesity may be prescribed drugs like Wegovy for long periods of time, Kraftson said. Those who stop taking the drug could regain the lost weight, he added.
“These drugs were not designed for normal-weight people who want to be super skinny,” Hwang said.
Who should take Ozempic and Wegovy?
After the FDA approved Ozempic for people with type 2 diabetes, the agency approved Wegovy for obese or overweight adults with at least one “weight-related condition,” which the agency considers problems such as high blood pressure, type 2 diabetes, or high cholesterol. The FDA defines obesity and overweight using body mass index, an entrenched but hotly debated metric.
Without insurance, the drug is expensive—Wegovy’s 28-day list price is $1,300 and Ozempic can cost about $892 a month without insurance—and no doubt people who don’t meet FDA criteria will have a hard time finding out. Insurance covers it.
Despite those hurdles, the increase in people using Ozempic off-label may be exacerbating the shortage, Narang said, noting that patients with diabetes and obesity have difficulty accessing the drug.
“It’s been very, very terrible: the patients don’t know where to go,” he said. “We’ve been like hamsters in a wheel trying to figure it out.”
“While we recognize that some healthcare providers may be prescribing Ozempic for patients whose goal is to lose weight, it is at the clinical discretion of each healthcare provider to choose the best treatment approach for their patients,” a statement said. representative of Novo Nordisk, adding that the company does not “promote, suggest, or encourage off-label use of our drugs.”
What are the side effects?
People taking Ozempic and Wegovy for both their FDA-approved and other uses may experience nausea and dehydration. They may also feel fatigue and discomfort. Their peristaltic movements may change: diarrhea occurs in some patients and severe constipation in others. “It can be so severe that people go to the ER,” Kraftson said. “It is not a joke”. Patients should be monitored while taking these drugs, he said, and doctors may prescribe other medicines to prevent nausea or laxatives or stool softeners. In very rare cases, the drugs may increase the risk of pancreatitis, a painful condition that inflames the pancreas. Some patients may also form gall stones. Gabbay said that she had seen patients with vomiting so severe that they had to stop their medication.
To minimize these side effects, Gabay added, doctors often start with low doses of drugs like Ozempic and Wegovy and then gradually increase them.
Is it dangerous to use these medicines outside of the indicated use?
Doctors say there isn’t enough evidence to know if these drugs can be beneficial or harmful for people who don’t meet the FDA’s criteria. As tempting as a weight-loss drug is, experts cautioned that people shouldn’t use it for off-label purposes. “If you’re just getting this over the internet it won’t have the same layers of protection,” he said. “I don’t want people to play roulette with their health.”
The drug has not been systematically tested in people who are underweight, Hwang said, adding that it is possible that patients outside the group for which the drug is designed could experience more severe side effects. Without further research, it cannot be determined how harmful the side effects might be.
“Going into the unknown is associated with some potential risk,” Gabbay said. “And we don’t know what it is.”