Off-label use of type 2 diabetes drug leading to shortages for patients in need

Feb. 24—Off-label use of a drug for type 2 diabetes is causing a shortage for those who legitimately need it, with some misusing the medication as a quick way to drop pounds.

Ozempic was approved by the FDA for use by type 2 diabetics, with the once a week subcutaneous injections designed to help prevent rises in blood sugar, to reduce insulin resistance and to help with losing excess weight that may be contributing to their health issues.

Gundersen Health System providers, says Dr. Rachel McKenney, endocrinologist and diabetes specialist at the hospital's La Crosse location, have been prescribing the drug for select type 2 diabetes patients since it was approved in late 2017, with many patients seeing success in addressing their condition. However, over the past six months Gundersen has seen "a large number" of patients calling about inability to have their prescriptions filled at local pharmacies.

The lack of access is due to its growing popularity as a method to lose weight, with either "well meaning" physicians prescribing it for such or individuals obtaining it without the support of a doctor at "wellness" or "anti-aging" clinics.

Use of Ozempic increased when Novo Nordisk could not keep up with the demand for Wegovy, designed specifically as a weight loss aid for those with a BMI of over 30, or 27 with weight-related health issues. Both Ozempic and Wegovy have the primary ingredient of semaglutide, with the latter containing a higher dose.

The scarcity of Wegovy also led to a shortage of Mounjaro, made from a different component, tirzepatid. It was approved in May 2022 for type 2 diabetics and has also been shown to spark weight loss.

Ozempic use poses no danger for a non-diabetic, save for the same potential side effects and risks to a diabetic patient.

"In fact, it would be great if every patient that had (obesity) would be able to access these medications," says McKenney. "But unfortunately they're very expensive and insurance does not cover the medications for weight-loss as the indication."

Wegovy, which has no generic alternative, is not covered by most Medicare and insurance plans, and the average retail cost, per GoodRx, is $1,718 per month. Ozempic out of pocket costs around $1,015, and while covered by some plans and Medicare, it is not covered for Quartz members, of which many local patients are, McKenney says. Trulicity, similar to Ozempic, is also difficult to find.

"Trulicity is the medication that is covered by a lot of the insurances in the area, and we've had patients that have had to go without, come up with some other alternative and use medications that aren't as beneficial for them," says McKenney.

As manufacturers work to replenish stock, McKenney says, patients "are going to have to endure this (shortage) for more than six months. So it's been a big problem."

Frustrating to patients and providers is the acquiring and utilization of drugs like Ozempic by those who are neither type 2 diabetic or significantly overweight. Tik Tok creators and high profile individuals have espoused the injections to drop 10-20 pounds rapidly and relatively effortlessly.

"It's not really a problem in our area, but in some other states there are anti-aging clinics and they often prescribe a lot of things off-label for patients," says McKenney. "And Ozempic has become attractive in Hollywood, some celebrities have been using that. If people can afford it and if they're willing and if they're desperate, they will pay that money."

Notably, any resulting weight loss is, for most, temporary, and the term "Ozempic face," describing the prematurely aging, gaunt visage of some users, is trending.

"Unless for some reason they have some kind of miraculous life-changing epiphany that results in a drastic lifestyle change or, let's say, they undergo weight-loss surgery — unless those things occur, if a patient goes back to their typical eating patterns, then they will definitely regain the weight," says McKenney.

The majority of clinicians would not in "good conscience" prescribe the drug off label, knowing the supply issue that could occur, says McKenney, "But I do think once in a while there might be someone that sneaks it through for a patient, with good intentions."

Drug and insurance companies, McKenney says, "have been cracking down on why you prescribe the medication. So now, when you prescribe these medications, you typically have to put that your patient has type 2 diabetes. So that's an additional layer of checks and balances that might make some well-meaning prescribers think (twice), knowing even if it would help (obese patients) you're having to actually type out something that you know is not true.

The makers of Ozempic, in a recent statement to media outlets, said, "While we recognize that some health care providers may be prescribing Ozempic for patients whose goal is to lose weight, Novo Nordisk does not promote, suggest or encourage off-label use of our medicines and is committed to fully complying with all applicable US laws and regulations in the promotion of our products."

But even with policies in place to help curb inappropriate prescribing of the medication, "You know it's not going to deter everyone from maybe falsifying a patient's information," McKenny says.

As drugs like Ozempic are proving beneficial to many type 2 diabetes patients, McKenny hopes they will become more widely available. While some may not respond, for others it is the "missing link."

"Those patients can experience a pretty significant drop in weight, their blood sugars improve significantly and we've had some really quite amazing success stories," says McKenny.

For many, going off the drug will lead to a regain of weight and increased blood sugar levels. However, says McKenny, "There are some patients that will take these medications and if they've had an impressive weight-loss result and they're able to maintain whatever lifestyle modifications they had employed with the medication, they can achieve a remission. It wouldn't be a lifetime sentence of the medication."

Common side effects of Ozempic include nausea, vomiting, diarrhea and abdominal pain, with some experiencing skin reactions at the injection site. Rare but serious side effects include pancreatitis, thyroid tumors, gallbladder problems or kidney issues. Patients, McKenny says, are counseled on symptoms and potential risks.The "take home point," McKenney says, "is that while these medications are excellent and it would be wonderful for everyone who needs to lose significant weight for various reasons to use them, the problem is it is affecting those patients that also need it for blood sugar control. And those patients are now currently suffering because they aren't able to access the medications that have been working well for them."

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