Why is it hard to get Ozempic?

health.com - Ozempic Shortage: Viral Trend Puts People With Diabetes at Risk - Health

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Ozempic, a drug to treat type 2 diabetes, is in short supply after demand spiked largely due to viral videos that show people using the medication to lose weight. The drug is not approved for weight loss, but some healthcare providers have been prescribing it off label for that use. The rise in demand proves how valuable these medications can be to treat weight loss, but the Ozempic shortage could put people with diabetes at risk. Semaglutide—a type 2 diabetes medication and weight management treatment—is currently in short supply, due to a spike in demand partially fueled by growing interest on social media. Two medications, sold under the brand names Ozempic and Wegovy, have garnered a lot of attention for their role in weight loss, particularly on TikTok and from certain celebrity figures, in the past few weeks. In an October tweet, Twitter CEO Elon Musk revealed he uses Wegovy to stay "fit, ripped, [and] healthy." TikTok users have also recently speculated that Kim Kardashian has used a drug like Ozempic or Wegovy to "drop a considerable amount of weight" in the past few months. And it's not just celebrities: TikTok videos with the hashtag "#ozempic" have gotten more than 250 million views on the app, many of which show people and their weight loss transformations on the drug. The hashtag "#wegovy" has a considerable amount of views as well, at nearly 100 million. Though Ozempic and Wegovy both have semaglutide as their active ingredient, the drugs are not interchangeable. Ozempic and Wegovy have different indications and dosages—Ozempic, for example, is approved by the Food and Drug Administration (FDA) to help manage type 2 diabetes; Wegovy is FDA-approved for chronic weight management. But the two drug shortages are likely somewhat linked. In March, Novo Nordisk, manufacturer of Wegovy and Ozempic, temporarily stopped shipments of lower doses of Wegovy (0.25 mg and 0.5 mg). Those dosages are still unavailable, as is the 1 mg dosage, but supply is expected to resume near the end of 2022. With the Wegovy shortage, there was likely an increase in demand—which then led to the current months-long shortage—for Ozempic. Though Ozempic is indicated to help manage type 2 diabetes, it also leads to weight loss—and could be prescribed for that despite lack of FDA approval, which is known as "off-label use." “From clinical practice and observing healthcare workers, they are prescribing Ozempic off-label while there's been a Wegovy shortage, and so I have seen that," Neel Shah, MD, associate professor at McGovern Medical School at the University of Texas Health Science Center at Houston, told Health.

According to some experts, that off-label us of the drug is problematic.

"I think there's an ethical concern here," Eduardo Grunvald, MD, medical director at the Center for Advanced Weight Management at the University of California, San Diego, told Health. "If you are using the medication for inappropriate purposes, you're taking the medication away from people who truly have type 2 diabetes and really need the medication." Here's what to know about the current Wegovy and Ozempic shortages, why semaglutide has become so popular for weight loss, and how people in need of their type 2 diabetes and weight management medications can manage their conditions in the face of supply issues.

Ozempic and Wegovy: How the Drugs Work

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Ozempic was approved by the FDA in 2017 to help manage type 2 diabetes, along with diet and exercise. The FDA also approved Wegovy in 2021 for chronic weight management in adults with obesity or who are overweight. Both contain semaglutide, which means they work similarly, but for different approved indications. "Really what they are is a slightly different chemical form of a naturally occurring hormone that comes from our intestines,” said Dr. Grunvald. That hormone is glucagon-like peptide-1 (GLP-1), which targets areas of the brain that help regulate appetite and food intake. Semaglutide then mimicks that hormone as a GLP-1 receptor agonist (RA). When it occurs naturally in the body, "this hormone will improve blood sugar or glucose regulation, it'll stimulate insulin from the pancreas, and also improves how your tissues respond to the insulin," said Dr. Grunvald. The hormone—and thus, the medication—also works to "turn off your appetite," said Dr. Gunvald. But in its synthetic form, semaglutide is longer-acting than the naturally-occurring hormone that does this; it stays in the intestines for a longer period of time, extending the period of fullness, which can eventually help people lose weight over time, Dr. Gunvald added. But it bears repeating that Ozempic and Wegovy are not the same medication, despite both being semaglutide. According to Novo Nordisk, "the products are not interchangeable." "[The medications] have different indications, different dose escalations and adjustments," said Dr. Shah. Research has also shown that semaglutide typically provides the best results regarding weight loss, compared to other interventions. "This is one of the forefronts of anti-obesity treatment," said Dr. Shah. "And so that's why the demand has skyrocketed for these medications." In a 2021 clinical trial published in the New England Journal of Medicine, participants lost about 15% of their body weight on a once-weekly injection of 2.4 mg of semaglutide (the dosage of Wegovy), compared to 2.4% on placebo—a placebo-subtracted difference of 12.4%. Meanwhile, other weight management drugs, though still effective, showed less of a placebo-subtracted weight reduction. According to a 2021 meta-analysis published in Current Obesity Reports, participants on a phentermine/topiramate (Qsymia) regimen lost 6.8% of their body weight compared to placebo; for liraglutide (Victoza) it was 5.4%, for naltrexone/bupropion (Contrave) it was 4%, and for orlistat (Xenical, Alli) it was 2.9%.

Barriers for Patients Who Rely on Semaglutide for Medical Conditions

According to experts, prescribing Ozempic off-label for weight loss—and potentially even prescribing Wegovy for patients who don't technically have obesity—is a bit of a medical gray area. "One can understand a physician's desire to use medication off-label for an obese patient, and I can completely understand that. I think the issue becomes the fad that it's created," Elaine Barfield, MD, associate professor of clinical pediatrics and pediatric gastroenterologist at Weill Cornell Medicine and NewYork-Presbyterian, told Health. “[Wegovy and Ozempic] shouldn't be abused by those who don't qualify for either of those diagnoses in particular.” The fad—which is at least partially to blame for the Ozempic drug shortage—is making it difficult for people with type 2 diabetes to access the medication they need. “It's been frustrating from a provider [and] healthcare worker standpoint, trying to prescribe these medications for our type 2 diabetic patients because of the shortage,” said Dr. Shah, recalling that he's personally had the issue come up multiple times with his own patients. The availability of the drug isn’t the only issue standing in the way of people accessing Ozempic or Wegovy—both drugs also carry a hefty price tag, especially when they're not covered by insurance.

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“What's frustrating about obesity medicine or assistance [for] patients with weight loss, is that a lot of these FDA-approved medications are not necessarily covered by insurance,” said Dr. Shah. “And it should be, because there's an under-recognition for obesity as a chronic disease and how that might affect other chronic diseases, such as hypertension or diabetes or other cardiovascular disease.” The list price of Ozempic is just about $900 for a one-month supply; for Wegovy, the list price jumps to about $1,350. Even if a person’s insurance does cover Ozempic or Wegovy, the co-pays themselves may put the drugs out of reach financially for many people, said Dr. Barfield. “This just is worsening access for many people who have type 2 diabetes in this country and are unable to obtain the medication they need,” Dr. Barfield added. “There's a risk of people becoming very ill, who are hospitalized because of complications of diabetes if they're not able to obtain this.”

What to Do if You're Affected By the Semaglutide Shortage

Despite challenges in accessing both Ozempic and Wegovy, there are other solutions that patients can take, experts explained. For those seeking a drug similar to Wegovy, the weight loss drug Saxenda (liraglutide) may be a good alternative, said Dr. Shah. The medication is also an injection, but it’s given daily and is FDA-approved to help people with higher body-mass indexes (BMIs) lose weight, he explained. People with type 2 diabetes also have options other than Ozempic, including other GLP-1 RAs like Victoza (liraglutide), Trulicity (dulaglutide), and Bydureon (exenatide). The FDA also recently approved Mounjaro (tirzepatide), a dual-targeted treatment for type 2 diabetes that is a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and a GLP-1 RA. As demand for the drugs has skyrocketed, Dr. Shah added that some people have also been seeking out compounded semaglutide, which some experts are referring to as a "bootleg" version of the true drug. These compounded drugs may still contain semaglutide, but mix it with other ingredients—which could affect its safety and effectiveness. It's for this reason compounded semaglutide is not FDA-approved, and is typically recommended against. The Ozempic and Wegovy shortages—and the popularity of the medications online—emphasizes how important and influential the medications could be going forward, said Dr. Grunvald. He added that more treatments that mimic intestinal hormones could be combined in medications to help more people lose weight and improve metabolic health over time. "Obesity is a biological disease, not just a lifestyle problem, and these treatments are usually more effective than just lifestyle interventions alone,” Dr. Grunvald said. “Especially for people who have obesity and have a lot of serious medical complications from it, these are wonderful therapies."

health.com - Ozempic Shortage: Viral Trend Puts People With Diabetes at Risk - Health

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