The demand for Ozempic, Wegovy, Zepbound and Mounjaro rose this year as the news of the drug’s dramatic weight loss results. But many people eager to get their hands on one of these once-a-week injectable medications are finding access difficult.
Patients face barriers to obtaining prescriptions and insurance. Price is a concern. Without a coupon or manufacturer’s warranty, the cost of Wegovy is $1,350 for a one-month supply, according to its manufacturer, Novo Nordisk. Zepbound for weight loss costs more than $1,000 according to the creator Eli Lilly.
Pharmaceutical companies also struggle 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 compound pharmacies that sell knockoff versions of these drugs for weight loss: compound semaglutide (as a substitute for Ozempic or Wegovy) and compound tirzepatide (as stand -in for Mounjaro and Zepbound).
A recent warning from the Food and Drug Administration (FDA) of the United States focused on the potential dangers of compound semaglutide, with the agency citing reports of unexpected health problems in people using the medication.
It’s a risk that many people seem willing to take in their quest to lose weight.
When insurance does not cover Wegovy, despair can occur
Sunnie (full name withheld for privacy), 50, has always had trouble calming her mind when it comes to food. “I feel like I’m wired to overeat,” she says.
Obesity runs in his family. His mother lost 100 pounds twice in her life, but gained it back.
Sunnie slowly gained weight while carrying 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 (a antidepressant) and naltrexone (a drug used to treat opioids). and alcohol use disorders). Contrave costs about $100 per month.
“It helped me control my thoughts about food by suppressing those cravings and urges in the brain,” says Sunnie. “But it stopped working.”
She was ready to try again when her doctor wrote a prescription for the drug semaglutide 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 lowers blood sugar levels, and interacts with the brain to curb appetite and signal a sense of fullness.
The FDA approved Wegovy in 2021 for obese or overweight adults who have at least one weight-related condition, such as high blood pressure, type 2 diabetes or high cholesterol.
That’s when Sunnie hit a wall: Because he doesn’t have a weight condition other than obesity, his insurance doesn’t cover Wegovy.
“I felt so defeated. I kept gaining weight. I felt like I was out of control and I needed something to get back in control,” she says.
Sunnie works in a hospital, which is where she heard about a cheaper alternative to Wegovy: compounded semaglutide, available from a nurse who told Sunnie she was reselling it from a compounding pharmacy. A few coworkers were taking the medication successfully, so Sunnie decided to go for it, buying a month’s supply for less than $300.
“I understand there is risk. I know it could be something,” says Sunnie. “I feel desperate. I feel that gaining weight is bigger than me and I realize that I need medication to help.”
Since she started taking the compounded drug in March, Sunnie has dropped 12 pounds and noticed a drastic reduction in her appetite, something she’s controlling.
“When I’m on weight loss medication, I can feel the difference between my brain telling me I’m hungry and my stomach telling me I’m hungry. I know I eat out of anxiety and boredom and there are many psychological reasons that I eat, but I’m able to separate those on semaglutide,” he says.
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Semaglutide compound and Tirzepatide are legal?
There are approximately 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 special needs, such as people who may be allergic to a certain dye in the brand name medication.
If there is a drug shortage, compounded versions become legal in the United States. In May 2023, the FDA included both Ozempic and Wegovy on its shortage list, legalizing compounded versions of the drugs.
The FDA recognizes that compounded drugs can fill an important need. But compounding drugs are not regulated by the FDA, which means there is no assurance that medications purchased from compounding pharmacies—even those sold by legitimate companies—are what they say they are.
Novo Nordisk says it does not sell its proprietary compounded semaglutide, raising questions about what, exactly, goes into compounded versions. No generic form of semaglutide exists, although compounded drugs are often marketed as such.
Novo Nordisk announced in June that it was taking legal action against medical spas, weight loss or wellness clinics, and compounding pharmacies that sell compounded or so-called generic versions of semaglutide, citing “potential safety concerns.”
According to the FDA, the compound versions of Ozempic and Wegovy may exchange 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 taking the compound semaglutide.
Pharmacies that sell compounded semaglutide sometimes also include vitamins such as B12 in the mix to allegedly increase weight loss, a claim for which there is no solid evidence, the Mayo Clinic says.
Semaglutide and Tirzepatide compounds are too risky, experts say
Juliana Simonetti, MD, co-director of the comprehensive weight management program at the University of Utah in Salt Lake City, says it’s “absolute madness” that insurance companies so often deny coverage of injectable drugs for weight loss in people with obesity. even for patients who have used these medications to get prediabetes under control. She understands what drives people to look for alternatives.
But, she says, there is no way to know for sure under what conditions compound drugs are created, and that anyone who buys compound drugs from a dubious source may run the risk of using medications that pose safety risks and may not even be barren
“I am very clear about telling my patients not to have composite versions. I feel their pain and despair, but I tell them not to because they are dangerous practices,” he says.
Andrew Kraftson, MD, the director of the Weight Management Program at Michigan Medicine in Ann Arbor, firmly believes in the value of medications like semaglutide, and understands why people scramble to take the drugs. He points out that obesity is highly stigmatized and undertreated.
“There’s this sense of urgency that leads people to make rash decisions,” he says. “They feel like, ‘This is out there now, it should have been yesterday.’
But without FDA oversight, Dr. Kraftson says, compounded versions are too risky. “It is problematic that there is this inherent conflict of interest,” he adds about providers who might be willing to compromise security in search of profit.
Plus, he says, people who buy cheap weight-loss medications aren’t typically getting nutritional advice to make sure they’re staying healthy when they drastically cut calories.
“Food as medicine is an important component here,” says Kraftson. “Someone could lose weight on 800 calories a day in the form of Twinkies, but that doesn’t mean they should.”
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