Is It Safe to Use Compounded Semaglutide and Tirzepatide for Weight Loss?

08 Jan.,2024


Demand for Ozempic, Wegovy, Zepbound, and Mounjaro has skyrocketed this year as news gets out about the drugs’ dramatic weight loss results. But many people eager to get their hands on one of these once-a-week injectable medications find themselves struggling for access.

Patients face roadblocks in getting prescriptions and insurance coverage. Price is a concern. Without a manufacturer’s coupon or insurance, Wegovy’s cost is $1,350 for a month’s supply, according to its producer, Novo Nordisk. Zepbound for weight loss costs over $1,000 according to maker Eli Lilly.

Pharmaceutical companies are also straining to produce enough of these medications to keep up with demand, leading to shortages.

The result is the rise of a niche industry of so-called compounding pharmacies selling knockoff versions of these weight loss drugs: compounded semaglutide (as a substitute for Ozempic or Wegovy) and compounded tirzepatide (as a stand-in for Mounjaro and Zepbound).

A recent warning by the U.S. Food and Drug Administration (FDA) focused on the potential dangers of compounded semaglutide, with the agency citing reports of unanticipated health problems in people using the medication.

It’s a risk many people appear willing to take in their quest to lose weight.

When Insurance Won’t Cover Wegovy, Desperation May Set In

Sunnie (full name withheld for privacy), 50, has always had a hard time quieting her mind when it comes to food. “I feel like I’m hardwired to overeat,” she says.

Obesity runs in her family. Her mother lost 100 pounds twice in her life but gained it back.

Sunnie slowly gained weight while bearing and raising her three children, reaching a body mass index (BMI) of 45. Her doctor put her on Contrave, a weight loss pill that combines bupropion (an antidepressant) and naltrexone (a drug used to treat opioid and alcohol use disorders). Contrave costs about $100 per month.

“It helped me control my thoughts about food by suppressing those desires and impulses in the brain,” says Sunnie. “But it stopped working.”

She was ready to try again when her doctor wrote her a prescription for the semaglutide drug Wegovy. As the FDA explains, semaglutide is a GLP-1 receptor agonist, a medication that mimics a natural hormone called GLP-1 that is released in the gastrointestinal tract in response to eating. GLP-1 prompts the body to release insulin, which reduces blood sugar levels, and interacts with the brain to curb appetite and signal a feeling of fullness.

The FDA approved Wegovy in 2021 for adults with obesity or overweight who have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol.

That’s when Sunnie ran into a wall: Because she doesn’t have a weight-related condition in addition to obesity, her insurance wouldn’t cover Wegovy.

“I felt so defeated. I was continuing to gain weight. I felt like I was out of control and I needed something to get back in control,” she says.

Sunnie works at a hospital, which is where she heard about a cheaper alternative to Wegovy: compounded semaglutide, available through a nurse who told Sunnie she was reselling it from a compounding pharmacy. A few coworkers were taking the medication with success, so Sunnie decided to go for it, buying a month’s supply for less than $300.

“I understand there’s risk. I know it could be anything,” says Sunnie. “I feel desperate. I feel like gaining weight is bigger than me and I’ve come to the realization that I need medication to help me.”

Since she started taking the compounded drug in March, Sunnie has dropped 12 pounds and noticed a drastic reduction in her appetite, something that used to control her.

“When I’m on weight loss medication, I can feel the difference between my brain telling me I’m hungry and my actual stomach telling me I’m hungry. I know I eat out of anxiety and boredom and there are a lot of psychological reasons I eat, but I’m able to separate those on semaglutide,” she says.

RELATED: Risks You Should Avoid When Buying Weight Loss Drugs Online

Are Compounded Semaglutide and Tirzepatide Legal?

There are about 7,500 licensed pharmacies in the United States that specialize in compounding, according to the American Pharmacists Association (APhA). These pharmacies mix, alter, or combine FDA-approved drugs with different ingredients for people with particular needs, such as individuals who may be allergic to a certain dye in the brand-name medication.

If there’s a shortage of a drug, compounded versions become legal in the United States. In May 2023, the FDA included both Ozempic and Wegovy on its shortages list, legalizing compounded versions of the drugs.

The FDA recognizes that compounded drugs can fill an important need. But compounded drugs are not regulated by the FDA, meaning there is no assurance that medications purchased from compounding pharmacies — even those sold by legitimate businesses — are what they claim to be.

Novo Nordisk says it does not sell its patented semaglutide for compounding, raising questions as to what, exactly, goes into compounded versions. No generic form of semaglutide exists, though compounded drugs are often marketed as such.

Novo Nordisk announced in June that it’s taking legal action against medical spas, weight loss or wellness clinics, and compounding pharmacies selling questionable compounded or so-called generic versions of semaglutide, citing “potential safety concerns.”

According to the FDA, compounded versions of Ozempic and Wegovy may swap out pure semaglutide for salt-based forms, which have not been shown to be safe and effective in clinical trials. The FDA says it has received reports of “adverse effects” from people who take compounded semaglutide.

Pharmacies selling compounded semaglutide sometimes also include vitamins such as B12 in the mix to allegedly boost weight loss, a claim for which there is no solid proof, says Mayo Clinic.

Compounded Semaglutide and Tirzepatide Are Too Risky, Experts Say

Juliana Simonetti, MD, a co-director of the comprehensive weight management program at the University of Utah in Salt Lake City, says that it is “absolute insanity” that insurance companies so often deny coverage for injectable weight loss drugs to people with obesity, even for patients who have used these medications to get prediabetes under control. She understands what’s driving people to seek alternatives.

But, she says, there is no way to know for sure under what conditions compounded drugs are created, and that anyone who buys compounded drugs from a dubious source may run the risk of using medications that pose safety risks and may not even be sterile.

“I’m very clear in telling my patients to not get compounded versions. I feel their pain and desperation, but I’m telling them not to do it because these are dangerous practices,” she says.

Andrew Kraftson, MD, the director of the Weight Navigation Program at Michigan Medicine in Ann Arbor, believes strongly in the value of medications like semaglutide, and understands why people are scrambling to get the drugs. He points out that obesity is highly stigmatized and undertreated.

“There’s this sense of urgency that’s driving people to make rash decisions,” he says. “They feel like, ‘This is out there now, I should have been on it yesterday.’”

But without FDA oversight, Dr. Kraftson says, compounded versions are too risky. “It’s problematic that there is this inherent conflict of interest,” he adds about providers who might be willing to compromise safety in pursuit of profit.

Plus, he says, people who buy weight loss medications on the cheap aren’t typically getting nutritional counseling to ensure they’re staying healthy when drastically cutting calories.

“Food as medicine is an important component here,” Kraftson says. “Anyone could lose weight on 800 calories a day in the form of Twinkies, but it doesn’t mean they should.”

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