Weight Loss

Weight-Loss Drug Shortage Brings Cheaper, Potentially Risky Alternatives

As demand for semaglutide injections outstrips supply, unapproved formulations flood the market, raising safety concerns over substitute ingredients.
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Weight-Loss Drug Shortage Brings Cheaper, Potentially Risky Alternatives
(Mario Tama/Getty Images)
George Citroner
1/22/2024
Updated:
1/22/2024
0:00

Wildly popular new weight-loss drugs like Ozempic and Wegovy are flying off shelves faster than manufacturers can keep up. This high demand has opened the floodgates for unapproved versions of the injectable medication.

This flood stirs safety concerns among regulators as compounding pharmacies rush to peddle their own drug formulations ahead of formal vetting.

Compounding Pharmacies Rush to Meet Demand

Semaglutide was developed by Novo Nordisk and is the active ingredient in Type 2 diabetes treatments Ozempic and Rybelsus and weight-loss drug Wegovy. As a glucagon-like peptide-1 (GLP-1) receptor agonist, it mimics a gut hormone, helping regulate blood sugar and appetite.

However, extraordinary weight loss from the drug has fueled demand, outstripping supply.

Unlike retail pharmacies, compounding pharmacies can mix tailored medications, producing versions of shortage drugs if requirements are met. Compounded drugs are not approved by the U.S. Food and Drug Administration (FDA). This means the FDA does not verify the safety or effectiveness of compounded drugs.

Some compounders are rushing unapproved semaglutide versions to market containing salts differing from Novo Nordisk’s formulation, according to the FDA. The agency confirmed it had received adverse event reports about compounded semaglutide and warned patients that products with salts like semaglutide sodium lack evidence for safety or efficacy.

In a letter to the National Association Boards of Pharmacy, the FDA said there is no legal basis for compounding drugs using semaglutide salts.

Case Reports Highlight Risks of Compounded Semaglutide

Incorrect dosing is a major problem for patients getting compounded semaglutide without guidance. However, many patients, especially the uninsured, are seeking compounded semaglutide due to the much lower price compared to name-brand versions of the drug. For example, while prescription Ozempic can cost over $900 per month, some compounding pharmacies offer their formulation for as little as $149 for one vial containing 5 milligrams of the active ingredient.
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Case reports in the  Journal of the American Pharmaceutical Association highlighted risks from self-administered, compounded semaglutide. Two patients had 10-fold overdoses, experiencing prolonged nausea, vomiting, and abdominal pain. Another received vials without counseling, leading to improper units-based dosing; a patient dosed themself in milliliters and units rather than the recommended milligram dose. One experienced side effects that included headache, anorexia, weakness, and fatigue.
The authors advised regulatory agencies to promote proper dispensing to avoid dosing errors and adverse events. “Such vigilance and promotion could decrease the risk of more severe adverse drug events and avoidable hospital utilization that may arise from dosing errors,” they wrote.

Novo Nordisk Doesn’t Validate Safety of Compounded Drugs

Novo Nordisk does not “directly or indirectly” provide or sell bulk semaglutide to compounding pharmacies or any other entities for making compounded versions of semaglutide products, the company said in an emailed statement to The Epoch Times.

“Medical spas, weight loss or medical clinics, and compounding pharmacies that are claiming to offer or sell compounded products claiming to contain ‘semaglutide’ are sourcing their ingredients from entities other than Novo Nordisk,” the drugmaker said. Novo Nordisk said it cannot validate the safety or efficacy of these unbranded products. “Patients can help protect themselves by only buying medicines from legitimate sources and with a prescription from a healthcare professional,” the company added.

However, compounding pharmacies play a valid role in providing customized medications to patients.

Licensed and regulated by state pharmacy boards, compounders legally make tailored drugs to fit individual needs under the Federal Food, Drug, and Cosmetic Act: Section 503A. This includes altering medications for allergies, taste, or swallowing difficulties.
Critically, they’re also allowed to manufacture approximations of brand-name drugs on the FDA’s drug shortage list to address supply shortages. Semaglutide currently meets that requirement.

Novo Nordisk Sues Over False Advertising of Unapproved Semaglutide

In November 2023, Novo Nordisk filed legal actions against medical spas, weight-loss or medical clinics, and compounding pharmacies for false advertising and selling unapproved semaglutide. The company found impurities in drugs from two Florida compounders, per Reuters.
In December 2023, the FDA seized thousands of fake Ozempic injections. Even the needles were counterfeit, meaning their sterility was unconfirmed, increasing infection risks for patients using these products.

Off-label prescribing for non-diabetes patients also contributes to shortages. Novo Nordisk said it asks doctors to prescribe semaglutide consistent with FDA-approved indications.

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George Citroner
George Citroner
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George Citroner reports on health and medicine, covering topics that include cancer, infectious diseases, and neurodegenerative conditions. He was awarded the Media Orthopaedic Reporting Excellence (MORE) award in 2020 for a story on osteoporosis risk in men.
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