Officials with the U.S. Food and Drug Administration have banned the sale of compounded weight loss drugs including Ozempic, Mounjaro, Wegovy and Zepbound.

And earlier this month, federal health authorities issued a warning about counterfeit versions of Ozempic that have been circulating throughout the U.S.

A revolution in weight loss drugs began in recent years when doctors and researchers discovered that drugs created to help control diabetes also spark dramatic weight loss. The newest research has continued to show other benefits including improved cardiovascular outcomes and better kidney health.

But the drugs are extremely expensive, and many insurance companies do not cover the medications when patients use them to lose weight rather than to control diabetes. Also known as glucagon-like peptide 1 receptor agonists or GLP-1s, the medications also can cause gastrointestinal side effects, and patients may need to take the drugs forever in order to keep the weight off.

High costs and challenging side effects haven’t stopped many people from clamoring to get the drugs, which can help patients lose 20% or more of their body weight.

The most famous of these drugs is Ozempic. It has become a household name thanks to omnipresent advertising and the drug maker’s “O-O-O” jingle that may ring in the heads of many Americans. Ozempic is actually a diabetes medication, not a weight loss drug. But it has become an umbrella name of sorts for the new class of GLP-1 medications. The generic name for the drug in Ozempic is semaglutide, which patients inject once a week. There is also a pill form of this drug that patients can take daily for diabetes; that’s called Rybelsus. When prescribed for weight loss, semaglutide is called Wegovy.

Weight loss drugs continue to surge in popularity as pharmacy experts warn patients to be wary of counterfeit GLP-1s

The newest weight loss drug is called Zepbound. That’s the brand name for a drug called tirzepatide. The version of tirzepatide for diabetes patients is called Mounjaro.

The manufacturer of Zepbound and Mounjaro, Eli Lilly, recently announced a new pill form of the medications, which currently only come as injections.

The popularity of all of these drugs has continued to explode as celebrities from Oprah to Whoopi Goldberg and Tracy Morgan have spoken publicly about their success in losing weight with the medications.

Millions of regular folks have followed suit. And many have hunted for cheaper options, buying compounded versions of the drugs or shopping online.

Fake versions of the drugs have prompted stern warnings from pharmacy experts and federal officials alike. Meanwhile, experts with the Food and Drug Administration (FDA) now are prohibiting compounded versions of GLP-1s.

To help patients stay safe if they are using Zepbound, Wegovy, Ozempic and Mounjaro, we consulted with experts.

Their key message is to be wary of all substitute weight loss medications from compounding pharmacies or medical spas. Patients should also be aware that some unscrupulous online sellers are marketing counterfeit weight loss drugs. Before taking any medication, always speak with your medical provider and obtain medications through trusted, licensed pharmacies.

“It’s an unnecessary risk to use compounded versions of these medications. We strongly recommend against it,” said Dr. Cecilia Low Wang, a UCHealth expert on endocrinology, diabetes and metabolism. “We can’t guarantee their sterility and safety. And if a compounding pharmacy tells you that there’s a certain amount of the active drug in an injection, that can’t be verified independently,” said Low Wang who is also a professor at the University of Colorado School of Medicine on the Anschutz Medical Campus.

“Be really careful about the potential for fraud,” said Low Wang, who chairs the committee that advises the U.S. Food and Drug Administration (FDA) about drugs related to endocrinology and metabolism. (Low Wang does not receive funding from the drug companies. And her views do not represent those of the FDA or the FDA Endocrinologic and Metabolic Drugs Advisory Committee.)

FDA bans compounded versions of weight loss medications

FDA officials banned the sale of compounded versions of the medications as of April 22 of this year.

Amy Gutierrez, vice president of pharmacy services for UCHealth, had previously warned patients not to use unsafe alternatives to legitimate FDA-approved medications.

“Given the FDA warnings, I would be very concerned with the safety parameters of acquiring semaglutide from a compounding pharmacy,” said Gutierrez, who has a doctorate in pharmacy.

“Some compounders also may be using salt forms of the medication, such as semaglutide sodium and semaglutide acetate, which have different active ingredients from those in the FDA-approved drugs. Products containing these salts have not been shown to be safe and effective,” Gutierrez said.

If deals for weight loss medications seem too good to be true, they’re probably not legitimate and may be unsafe, she said.

“The FDA-approved drugs are costly for patients who don’t have insurance coverage,” Gutierrez said. “If the compounding pharmacy is selling medications for $350, these compounded agents may not contain the same active ingredients as the FDA-approved product, and may have potential safety concerns.”

The sticker price for Ozempic, Wegovy, Mounjaro and Zepbound in the U.S. ranges from $1,200 to $1,400 per month. People who pay cash for the medications can get them directly from the manufacturers for about $550 per month. That’s far higher than patients pay in Europe, where monthly doses cost about $100. And recent research from experts at the Yale School of Medicine estimated that pharmaceutical companies could produce the drugs for as little as 75 cents per person for four monthly doses.

Dr. Annie Moore is an internal medicine doctor who is board certified in obesity medicine and has extensive experience prescribing the newest weight loss medications to her patients.

The real medications have been game changers for many patients, said Moore, who cares for patients at CU Internal Medicine – Cherry Creek. 

“They’re great for the right person,” said Moore, who is also a professor of clinical practice, medicine and internal medicine at the University of Colorado School of Medicine and researches best practices in patient care through the Brown Moore Endowed Chair for Excellence in Patient Experience.

But due to high costs and medication shortages, she said some of her patients have turned to compounded medications or online versions, which she warns can be dangerous and ineffective.

Why are GLP-1 weight loss drugs so popular?

The drugs are extremely popular because they often work. Clinical trials showed that the medications were both safe and effective and helped people lose significant percentages of their body weight. (Learn more about the pros and cons of Ozempic and Wegovy and the basics about Zepbound.)

The drugs also have dramatically changed the way medical experts think about obesity. In the past, some doctors and researchers blamed the world’s obesity epidemic on individuals and their diets and lifestyle choices.

Now, while the prevalence of highly-processed foods, sugar-sweetened beverages and sedentary lifestyles certainly contribute greatly to weight gain, research is showing that people with higher body mass indexes, or BMIs, are more likely to be predisposed to gain weight easily and keep on extra pounds.

Medical experts now focus on brain chemistry in addition to stressing the importance of healthy behavior change. One of the reasons that the new weight loss drugs are effective is that food moves more slowly through the digestive system, making people feel satiated sooner. They also seem to help people who feel like they’re addicted to unhealthy foods and thus, make it easier to stick with healthy lifestyle resolutions.

How can patients stay safe?

Patients should only get prescriptions for weight loss medications through a trusted medical provider. If they qualify for GLP-1s, they should only get the drugs through real pharmacies.

What should patients do if they’ve been using compounded medications or they can’t get their next dose? Is it dangerous to stop taking weight loss drugs suddenly?

No. It’s not dangerous to stop the medications suddenly because they are long-acting, meaning that the medication will stop working gradually over time.

Evidence has shown, however, that most people who stop taking the drugs gain at least some of the weight back.

Patients likely will find that their appetite increases.

“Unfortunately, these medications don’t change your brain permanently. They change your brain while you’re on the medication,” Moore said.

“There are people who sustain significant weight loss through huge amounts of effort and personal discipline. But that’s the exception,” Moore said.

Should patients consider spacing out doses of weight loss medications by more than a week to ration the drugs so they can save money and use fewer doses?

The FDA approves medications to be used according to manufacturers’ exact instructions. But Moore said that some of her patients who are worried about high costs have been trying to stretch to 10 to 12 days between doses rather than a week. She said it’s not dangerous to stretch the doses, but it’s unclear whether the drugs will be as effective.

There’s no research yet on how effective it is to take doses less frequently. Diabetic patients or those who are taking medications to improve cardiovascular or kidney health should take medications as prescribed.

“If people with diabetes are missing doses, that could cause concerning effects on blood sugar levels, and the benefits to reduce heart disease risk or kidney disease are likely to be less,” Low Wang said.

I’m thinking of starting on one of these medications. Since there are counterfeit versions out there and compounded versions will no longer be available, should I reconsider starting on drugs like Ozempic, Mounjaro, Wegovy and Zepbound?

Patients who are considering starting on one of the newest weight loss drugs will want to think carefully before starting on the medications, doctors said.

That’s because they’re still very expensive.

“The first question I ask patients is, ‘Does your insurance cover it?’” Moore said.

For most people, the answer to that question is “no.”

But a surprising number of people are willing to pay hundreds of dollars out of pocket each month, Moore said.

For highly motivated patients who have money to pay for prescriptions, Moore said patients are finding doses, and most love the results.

“It just takes so much work on the patient’s part,” she said. “The second question I ask is, ‘Do you have the time to look for a needle in a haystack every month?’

“People who can put at least an hour-and-a-half a month into researching where they can find it usually succeed, but finding doses really involves a lot of heavy lifting on the patient’s side,” Moore said.

She spends considerable time setting expectations with patients so they can make informed decisions about whether to try weight loss drugs.

For people who are not at high risk of getting diabetes and have their blood pressure under control, it may be wise to wait.

“The right answer may be to say, ‘Hey, I’m going to watch and wait until insurance coverage for these medications gets better.’ We’ll see when we get the first generic version of these drugs,” Moore said.

She and other doctors say there are deep inequities related to who can access the drugs.

People who can easily pay the high prices for the medications are getting them. Meanwhile, lower-income patients, people of color and those who are not tech-savvy may not be getting the help they need, Moore said.

She conducts research on how patients access care, and those who are uncomfortable with digital tools like using apps and emailing their doctors are not receiving the same level of care and the same access to popular new weight loss drugs as those who are tech savvy and comfortable advocating for themselves.

Are there ways to save money on these expensive drugs? Is insurance coverage improving?

Many employers and insurance providers are not covering the weight loss drugs, and coverage doesn’t seem to be improving for now, doctors say.

The drug companies offer some coupons to help reduce the cost of the drugs for people without insurance coverage. Learn about coupons for Wegovy and Zepbound.

Are there other new medications on the horizon that might help with the shortages for Wegovy and Zepbound?

Yes. There are many new medications in development. And shortages should ease eventually.

“There are a lot of medications on the horizon,” Low Wang said.

“Each study seems to show that the next medication is at least as good as or better than the previous ones are. There’s really, really amazing work that’s being done.

“There are triple peptides and new combinations being studied intensively,” she said.

It’s unclear, however, exactly when medications now being studied will win FDA approval.

“We’re expecting to see many new medications over the next several years,” Low Wang said.

Moore is very optimistic about the future of weight loss drugs.

“There are probably 100 medications in the pipeline. I can’t tell you exactly when the next one is going to be released,” Moore said.

When pill forms are available, she expects access to improve and prices to go down.

Drug makers are highly motivated to find the next blockbuster weight loss drug since they are profiting greatly from these medications.

Moore also said we’ve experienced other eras in medicine in the U.S. when drug shortages and high prices have prevented patients from getting highly effective medications that would greatly benefit their health. Over time, markets, drug manufacturers and insurance coverage caught up, and the costs of beneficial drugs declined.

She cites statins, for example. These cholesterol-reducing drugs came on the scene in the late 1980s. At first, they were extremely hard to get, and patients were having to pay at least $400 a month for prescriptions, a very high price at the time.

“It was pretty prohibitive. Now, we have many statins, and they are inexpensive and widely available for patients,” Moore said.

Do people who take these drugs to lose weight need to keep taking them forever?

From all that doctors and researchers know so far, it’s likely that patients will need to keep taking the medications in order to avoid gaining weight again.

The newest medical term for obesity is “excess adiposity,” meaning that people who are affected are more resistant to efforts to lose excess fat. Another term is “adiposity-based chronic disease,” which focuses on adverse health outcomes that a person might be at risk for or develop from having excess weight.

“This is a chronic condition, just like high blood pressure. And when you stop taking a blood pressure medication, you expect your blood pressure to go up again. The same is true for excess adiposity. If you stop taking a medication, then we expect the weight to be regained,” Low Wang said.

Some emerging studies are showing that it may be possible for patients to taper off of weight loss drugs or take lower doses and maintain a lower BMI.

“An important part of that involves making effective, sustainable lifestyle changes,” Low Wang said.

What if people can’t find the drugs and have to go off of them for a while? Since people gradually work up to higher doses, will they have to start over again with the lowest doses?

Yes. That’s possible, Low Wang said.

“If you’re off of the drugs for several weeks, then you may have lost the ability to tolerate the side effects and you might need to start at a lower dose,” Low Wang said.

Patients and their doctors will want to make decisions about medications and specific doses together, she said. 

How are doctors and pharmacists dealing with such high demand for weight loss drugs?

Most health professionals go into the field because they love helping people. But the rush to get weight loss medications and constant questions about them are causing challenges.

Medical providers and their assistants are having to deal with many, many emails, phone calls and visits from patients who either want to start weight loss drugs or have questions once they are using them.

“We have an entire team helping, but it’s been pretty difficult,” said Low Wang, who, like other health care professionals, doesn’t like to complain.

“We make every effort to go above and beyond for every patient,” she said.

The greatest frustrations stem from lack of insurance coverage for medications that clearly are working for many patients.

“Many times, we have to jump through a lot of hoops,” Low Wang said.

Moore said primary care doctors are trained these days to discuss obesity and potential treatments with patients who bring up the topic. That’s a big change from an era when many people with higher BMIs felt stigmatized in doctors’ offices and, as a result, some avoided medical care.

The best practice now is to deliver “patient-driven care,” Moore said.

“That means that if a patient is relatively healthy — even with a high BMI — and they are not interested in weight loss medications, we support that decision,” Moore said. “If patients want to start on these medications, we want to help them. It’s up to the patient. The history of shaming makes this shared decision making especially important.”

As the only board-certified obesity specialist in her primary care clinic, Moore is doing all she can to educate her colleagues about the newest medications and the profound effects they can have for patients.

“This is a chronic health condition, just like other things we treat, like hypertension,” Moore said.

She’s finding that a very high percentage of patients would qualify for the medications and want to talk about getting prescriptions. With new coverage for Medicare patients, Moore is receiving more requests for Wegovy than ever before.

“I do at least one new prescription every day,” she said.

She’s doing her best to keep up with constant queries about new prescriptions and shortages.