I am a pharmacist. Knockoff Ozempic and other weight loss products have serious hidden dangers

In just a few years, brand name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have become famous as annual billion dollar sellers for weight loss. body as well as controlling blood sugar levels and reducing the risk of heart disease.

But the price of these injections is steep: They cost about $800-$1,000 a month, and if they are used only for weight loss, they are not covered by most insurance policies. Both drugs mimic the natural hormone GLP-1 to help control blood sugar and reduce cravings. They can only be taken with a prescription.

The Food and Drug Administration announced an official shortage of the active ingredients of these drugs in 2022, but on October 2, 2024, the agency announced that the shortage has been resolved for the drug tirzepatide, the active ingredient of Mounjaro (LLY) and Zepbound .

Despite the increasing demand and limited supply of these drugs, there are no generic versions available. This is because the patents for semaglutide – the active ingredient in Ozempic (NVO) and Wegovy, which is still lacking – and tirzepatide do not expire until 2033 and 2036, respectively.

As a result, over-the-counter and over-the-counter alternatives are flooding the market. However these products come with real risks for consumers.

I am a pharmacist who studies loopholes in government regulation of over-the-counter drugs and dietary supplements in the US. My research team recently investigated the loopholes that allow some weight loss products to enter in the market.

High demand drives GLP-1 wannabes

The dietary supplement market has sought to capitalize on the demand for GLP-1 with pills, teas, pills and all kinds of other products that claim to produce the same effects as the brand names at a much lower price.

Products containing the herb berberine offer only a few pounds of weight loss, while many weight loss products contain stimulants such as sibutramine and laxatives. such as phenolphthalein, which increase the risk of heart attack, stroke and cancer.

Poison control centers have seen a sharp rise in calls related to weight loss medications.

Part of compounding pharmacy

Unlike dietary supplements that masquerade as GLP-1 weight loss products, compounding pharmacies can create generic versions of products that contain the same ingredients as the real thing. for patients who cannot use the usual brand or products for some reason.

These chemicals can also produce other types of brand-name drugs when there is a legal shortage of drugs.

Since demand for GLP-1 drugs has far outstripped supply, compounding pharmaceuticals are officially producing different versions of semaglutide and tirzepatide.

These products may come in different forms than the brand-name ones, such as vials of powder that must be dissolved in water, or as tablets or nasal sprays.

As with brand-name drugs, you must have a prescription to get them. Prices range from $250-$400 per month – still affordable for most consumers.

Compounding drugs must follow FDA standards for sterility and manufacturing quality, but these rules are not as strict for compounding pharmacies as for commercial manufacturers of generic drugs.

In addition, compounding pharmacy products do not have to be tested on humans for safety or effectiveness as brand name products do.

Adequate intake can also be a challenge with mixed types of drugs.

Companies operating in the system

For people who can’t afford the compounding chemical product, or can’t get a valid prescription for semaglutide or tirzepatide, opportunistic companies are stepping in to fill the void. These include “peptide companies,” manufacturers that make non-FDA approved versions of the drug.

From November 2023 to March 2024, my team conducted a study to evaluate which of these peptide companies are selling semaglutide or tirzepatide products. We scoured the internet for these peptide companies and gathered information about what they sell and their sales methods.

We discovered that the peptide marketers are using the loophole to sell these drugs. On their websites, companies state that their drugs are for “research purposes only” or “not for human use,” but do nothing to verify that customers are researchers or that the product is going to a research facility.

By reading the comment sections of company websites and targeted ads on social media, it’s clear that consumers and marketers understand the charade. Unlike compounding pharmacies, these peptide suppliers do not provide the equipment you need to break up and inject the drug, they do not provide prescriptions, and they often cannot answer questions.

Peptide sellers, since they are said not to be selling to consumers, do not need a prescription and will sell to consumers any type of drug they want to buy. Even if a person has an eating disorder such as anorexia nervosa, companies will be happy to sell them a semaglutide or tirzepatide product without a prescription. Average prices for these peptide products range from $181-$203 per month.

Skirting Rules

Peptide sellers do not have to follow the rules or regulations that drug manufacturers or compounding pharmacies do. Many companies claim that their products are 99% pure, but an independent investigation of the products of three companies from August 2023 to March 2024 found that the purity of the products was much lower than more than promised.

One product contained endotoxin – a toxic substance produced by bacteria – suggesting it had been contaminated by pathogens. In addition, the promised values ​​of the products decreased by 29% to 39%. Poor hygiene can cause patients to develop fever, chills, nausea, itchy skin, infections and low blood pressure.

In this study, some companies have never sent drugs, telling consumers that they need to pay an additional fee to make the product clear customs.

If a consumer is injured by a low-quality product, it may be difficult to sue the seller, since those products clearly state that they are “not for human use.” Finally, consumers are directed to spend money on products that may not arrive, may cause contamination, may not have the correct dosage, and do not have instructions for use or storage. product safely.

Will name brand prices drop?

To combat these other sellers, the pharmaceutical company Eli Lilly started to offer another version of its Zepbound weight loss product in September 2024.

Instead of its traditional pen products that cost more than $1,000 for a month’s supply, this product comes in vials that patients draw and inject themselves. For patients taking 5 milligrams of Zepbound each week, the vials would cost them $549 a month if patients buy it through the company’s company and can show that they don’t they have insurance for drugs.

After a delicious meal on Capitol Hill in September 2024, the pharmaceutical company Novo Nordisk came under intense pressure to offer patients without a prescription a low-cost product for its brand name Wegovy .

In the next few years, other brand name GLP-1 drugs may make it to market. As of October 2024, several products are in late-stage clinical trials, with active ingredients such as retatrutide, survodutide and ecnoglutide, and more than 18 other people who are already in early stage nts development.

When new pharmaceutical companies enter this market, they will have to offer patients lower prices than Eli Lilly and Novo Nordisk in order to gain market share. This is the medium-term solution to lower the cost of GLP-1 drugs and eliminate the shortage of drugs in the market.

C. Michael White is Distinguished Professor of Pharmacy Studies at the University of Connecticut. This article is reprinted from The Conversation under a Creative Commons license. Read the first article.

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