Weight loss with Ozempic or Wegovy can be frustrating when it comes to the availability and price of the popular drugs. That’s driving some people to compounding pharmacies for copycat treatments, but is it safe?
The U.S. Food and Drug Administration weighed in on the matter on May 31, warning that it has received "adverse event reports" after patients used compounded semaglutide — the active ingredient in Ozempic and Wegovy.
Both self-injected medications are listed as “currently in shortage” by the FDA and both are expensive if not covered by insurance. Wegovy, the version of diabetes drug Ozempic actually approved for weight loss, has a list price of $1,349 for a month’s supply.
Why are patients turning to compounding pharmacies?
Compounding pharmacies offer semaglutide at cheaper prices.
Semaglutide is a synthetic version of a hormone known as GLP-1, which the body releases into the intestine when people eat food. That leads to reduced appetite and slows down stomach emptying, which may contribute to feeling full sooner, doctors say.
Compounding pharmacies claim to basically make that synthetic hormone, and then send the patient the raw materials, along with something to mix them with and a syringe, said NBC’s senior medical correspondent Dr. John Torres on TODAY in March.
Compounding is the process of combining, mixing or altering ingredients to create a medication tailored to a patient’s needs, the FDA notes. When a drug is in shortage, compounders may be able to prepare a compounded version if they meet certain requirements, the agency adds.
But patients won’t get the injector pen that comes with Ozempic or Wegovy, which is what’s really in short supply, Torres added.
Is semaglutide from compounding pharmacies safe?
“You have to be careful with those (products) because those are not FDA-approved products, they’re not really watched by the FDA that well so it’s kind of a little bit of a wild West — you don’t know exactly what you’re getting,” Torres cautioned.
The FDA does not verify the safety, effectiveness or quality of compounded drugs, the agency reminds consumers in its May 31 warning. It does not offer details about what types of "adverse events" patients who used compounded semaglutide have experienced.
Poor compounding practices can result in quality problems, such as contamination or a drug that contains too much active ingredient, which can lead to serious injury and death, the FDA cautions in a general note about compounding.
"Patients should not use a compounded drug if an approved drug is available," the agency says.
Novo Nordisk, the pharmaceutical company that makes both Wegovy and Ozempic, says it does not sell Wegovy or semaglutide for the purposes of compounding with other products.
“We have not conducted studies to evaluate the safety and efficacy of Wegovy when compounded with other ingredients,” the company says on its website.
“Novo Nordisk is the only company that has FDA approval to market Wegovy and we supply it in a disposable single-use pen available by prescription only.”
Is semaglutide from compounding pharmacies the real thing?
There is no lower-cost generic version of semaglutide approved, so what goes into these cheaper products?
The FDA says it has received reports some compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, which are different from the active ingredient used in Ozempic and Wegovy. Products containing these salts have not been shown to be safe and effective, the agency warns.
Benjamin Jolley, a pharmacist and owner of Jolley’s Compounding Pharmacy in Salt Lake City, told NBC News semaglutide sodium is a cheaper and modified version of the compound intended for research use only.
Compounding pharmacists could also be buying high doses of semaglutide from wholesalers and then separating it into smaller dosages or mixing it with other drug ingredients, he said.
Are patients using compounding pharmacies getting semaglutide at all?
“That’s the million-dollar question,” Dr. Fatima Cody Stanford, a physician specializing in obesity at Massachusetts General Hospital in Boston who serves as an adviser to Novo Nordisk, told NBC News.
Patients should only buy drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA, the agency notes.
Buying medicine online from unregulated and unlicensed sources can expose consumers to potentially unsafe products, it adds.