Why using Ozempic for weight loss is potentially unsafe in the wrong hands

Editor’s Note: This is the second of a two-part series about the shortage of the popular drug Ozempic, which is for those suffering from diabetes.

Just because someone says a product is FDA-approved, doesn’t mean it is.

Dr. Nuzhat Chalisa, a board-certified endocrinologist with the Morris Hospital Endocrinology Specialists, said she gets calls all the time from patients who are confused about the shortage of Ozempic. Patients will say their friends are using Ozempic for weight loss and paying just a few hundred dollars for it.

But the answer is simple.

“People don’t understand what they’re getting from med spas or clinics are compounded products that they’re selling as FDA-approved products.” Chalisa said.

For insurance coverage, patients need the diagnosis of Type 2 diabetes, Chalisa said.

“But if a doctor is prescribing Ozempic without a diagnosis of Type 2 diabetes, people are paying out of pocket for it,” Chalisa said.

[ Ozempic for weight loss hype causing shortages for diabetic patients that need drug ]

Occasionally, Chalisa said, a doctor might prescribe an off-label use of an FDA-approved drug because it’s medically necessary and “in the best interest of the patient.” In the case of Ozempic, doctors must do a full evaluation with their patients to make sure Ozempic is appropriate for them.

“For the use of GLP-1 medicines, if you have a personal or family history of medullary thyroid cancer, than it’s contraindicated,” Chalisa said.

Chalisa said some clinics that offer Ozempic for weight loss merely have a representative talk to a patient for five to 10 minutes.

“It’s really scary,” Chalisa said. “For the most part, compounded drugs are not FDA-approved. The FDA makes sure the drug is safe and created under sterile conditions. … But if it contains too much of the drug, it can really lead to patient injury.”

Chalisa said some med spas offer Ozempic, too. But how much of the original product is in the compounded version? What ingredients are mixed in? Could they damage the liver or kidney? Chalisa said consumers should ask these questions.

Furthermore, Ozempic is not without risk of side effects, especially gastrointestinal side effects, even when properly prescribed, Chalisa said. These side effects may include nausea, diarrhea, vomiting and even gall stones or pancreatitis, Chalisa said.

“Any medicine comes with some risk,” Chalisa said. “But when we prescribe medication, we weigh the risk versus the benefits. For most of our patients, the benefits are way more than the risks; that’s why we prescribe it. If people use it off-label and they are not families with the side effects, they may actually cause more injury than benefit.”

Legitimate reasons pharmacists compound medications

Frank Butler, director of pharmacy at Silver Cross Hospital in New Lenox, said compounding under certain circumstances is “something normal for pharmacies to do” if the pharmacist has a doctor’s order for it.

For instance, a patient may need medicine that they cannot take in the FDA-approved manner or they can’t handle a part of the concentration or an inactive ingredient, Butler said.

“But with some of these spas, they start to mix in other things, like vitamins, as a sort of marketing ploy,” Butler saiid.

Butler said not all medicines and vitamins are compatible.

“When put together, they lose the effect of both of them,” Butler said. “Or maybe they create something hazardous to you. Just because they’re vitamins doesn’t mean that [the product] is safe if it’s not handled appropriately or used appropriately.”

If a child needs an antibiotic that’s only available in a capsule, a pharmacist could compound an oral suspension or solution in a dose that’s safe for children and has the appropriate amount of active medication, Butler said.

A pharmacist may also compound a medication if smaller doses or different concentration is needed, Butler said. These are examples of appropriate uses of compounding by a pharmacist with a doctor’s order, Butler said.

So, pharmacists use an FDA-approved drug and compound it into a form or concentration that is not FDA-approved but in a form that a particular patient needs in order to take the drug, Butler said.

“What you want is an active drug that is safe and effective for what you’re trying to do. That is the basis of compounding,” Butler said. “There has to be a need to do it and it must be done in a safe manner.”

Butler said patients can’t get Ozempic without a prescription “so there needs to be a doctor involved in that,” Butler said.

“A pharmacist just can’t create something with prescription medication and have that be an approved formulation,” Butler said. “It would be dangerous to do that.”

And in some cases, it might also be illegal, Butler said.

So what about medical spas?

From a consumer standpoint, a med spa is not legitimate if a doctor is not overseeing it, Butler said. Consumers should ask questions on how any medication offered there is being compounded.

“Are they approved to do compounding? Are they licensed to do compounding? Those are questions they should ask,” he said. “Especially with an injectable drug, sterility is important.”

If vitamins are added, are they compatible with the medication? Have any of the ingredients expired? When was the compound made – a week ago or shortly before the consumer arrived at the clinic?

“Those are valid questions to ask,” Butler said. “You are taking a risk when you go outside those normal pathways.”