You can get Ozempic alternatives online. What are the risks?

When Bonnie Lange learned that her insurance did not cover the weight-loss drug Wegovy, she knew she could not pay the cost out of her own pocket, at over $1,300 a month.

Instead, it opted for the compound semaglutide, a drug that contains the same active ingredient as Wegovy and Ozempic but is not approved by the U.S. Food and Drug Administration.

The 59-year-old from Columbus, Ohio, said it was easy to get the medication online. There were a “jack of all trades” of companies to choose from; all she had to do was fill out a questionnaire and talk on the phone with her chosen telemedicine provider. Minor side effects like nausea were unpleasant, but after a month she lost 12 pounds.

“It's been a good experience for me,” said Lange, who pays about $200 a month for her one-year prescription.

There are other success stories like Lange's: people who have found in prescriptions an affordable, easily accessible substitute for the lack of branded products. But some health experts are sounding the alarm about the risks associated with alternative medicines.

What is compounded semaglutide?

When there is a shortage of FDA-approved brand-name drugs — such as the GLP-1 drugs Ozempic and Wegovy — the FDA allows pharmacies to make alternative drugs that are “essentially a copy” of the brand-name drug with the same active ingredient. In this case, it's semaglutide, an appetite suppressant. The pharmacies that make their own products are typically regulated by state pharmacy boards and source their ingredients from FDA-registered facilities, but the agency does not review the safety, effectiveness or quality of their drugs.

⁠⁠Novo Nordisk – the company that makes Ozempic and Wegovy – has clarified that it “does not directly or indirectly supply or sell semaglutide in large quantities to pharmacies,” and the FDA said in January that it had received reports that some pharmacists were using salt forms of semaglutide, which is not the same active ingredient as the base form of semaglutide used in brand-name weight-loss drugs.

Some pharmacies that make drugs themselves have a better reputation than others, but “there is no guarantee that they have the same rigorous safety profile,” says Dr. Diana Thiara, medical director of the Weight Management Clinic at the University of California, San Francisco and assistant professor of clinical medicine.

“For safety reasons, we never recommend compounding to patients,” Thiara said.

As of July 15, the FDA has received more than 31,000 reports of “adverse events” suspected to be related to a semaglutide product. Data from the agency's Adverse Event Reporting System (FAERS) show that more than 280 of these events were related to compounded drugs intended to contain semaglutide. However, this number may be an undercount because some reports were submitted by patients who may not realize or report that their drug is a compounded drug.

Another problem is ease of access. Some online providers require a phone call or video consultation with the doctor, but getting a GLP-1 prescription online does not always require proof of body mass index or laboratory tests. This could make it easier for patients to falsify information, according to Thiara.

“There is no compelling evidence that this is a drug that could help anyone medically,” she said.

Counterfeit GLP-1 drugs:Patients seeking to lose weight are warned against fake Ozempic as the number of popular counterfeits of the drug increases

And not every online pharmacy operates legally. The National Association of Boards of Pharmacy, a nonprofit organization that represents state pharmacy regulators, has identified more than 40,000 online pharmacies that do not comply with patient safety standards or laws.

Novo Nordisk has found evidence of compounded drugs with or without semaglutide, according to a May press release. The drugmaker has filed several lawsuits to try to stop medical spas, weight-loss clinics and pharmacies from illegally selling the compounded drugs.

However, there are also legally operating pharmacies that manufacture drugs themselves. Proponents argue that these drug manufacturers play an important role by offering alternatives in the face of brand shortages.

FDA-approved drugs “should always be the first choice” when available. But a homemade drug can be a safe alternative and should not be confused with illegal counterfeits, says Tenille Davis, chief counsel for the Alliance for Pharmacy Compounding, an advocacy group for pharmacy manufacturers.

As long as patients get their prescriptions from legitimate doctors and take the drugs from legitimate pharmacies, “there are regulatory frameworks in place to make this as safe as possible,” Davis said.

Davis recommends using state board of pharmacy websites to make sure a pharmacy that makes drugs is licensed. The FDA website also offers tools to find reputable online pharmacies.

Is there a risk of overdose?

Unlike Ozempic or Wegovy, which come in prefilled pens, compounded semaglutide is often administered in vials that patients measure themselves. The FDA issued a warning earlier this year that dosing errors can lead to “adverse events, some of which require hospitalization.”

As of June 30, there were 159 calls to U.S. poison centers related to compounded GLP-1 drugs, according to U.S. poison control centers. That's about 4% of the 3,866 calls related to all GLP-1 drugs during that period, but it's an increase from the 32 calls in all of 2023 for compounded GLP-1 exposure.

“Many of these cases involve people who attempted to use the drug for therapeutic purposes and made a mistake in administering it,” said Kait Brown, clinical director of U.S. Poison Control.

Brand-name weight-loss drugs can cause nausea and digestive problems, and an overdose of semaglutide can cause similar — and sometimes more serious — side effects, such as nausea, vomiting, fainting, dehydration, acute pancreatitis and gallstones, according to the FDA.

And since it takes about a week for half of the drug to be eliminated from the patient's body, potential side effects of an overdose may last longer.

“Let's say you take too much and you get really nauseous or vomit,” Thiara said. “That side effect will last for a while.”

Lange – a former physician's assistant – said even she had trouble figuring out how to measure her first injection from Hims & Hers, a telehealth provider that originally focused on erectile dysfunction drugs and hair loss treatments. Lange said she was able to get things sorted out after calling a customer service hotline.

Pat Carroll, Hims & Hers' chief medical officer, said the company offers educational materials and a support team available seven days a week to help patients administer the correct dosage. He also described the company's intake form as “extensive.” The process varies depending on the patient's home state, but typically involves a list of up to 100 questions that are reviewed by an approved provider and, in certain cases, a video call.

“The price of these drugs and their availability is still a big issue. High-quality, compounded drugs on a platform like ours can really play a role in terms of affordable access,” Carroll said.

The company, which announced the launch of compounded semaglutide offerings in May, reported a 52% year-over-year increase in sales in the latest quarter.

Ro, another popular telemedicine company, offers an intake process that includes a medical history and goals questionnaire and a mandatory photo or virtual visit. A Ro-affiliated provider reviews the patient's information and may order a lab test “if more information is needed,” the company's website says.

If patients have questions or need support, they can schedule a coaching session with a nurse or contact their doctor or pharmacist, according to Ro spokesman Nicholas Samonas.

Healthcare marketplace Sesame, one of the newest providers of compounded semaglutide, requires in-person consultation with a provider and offers its product in prefilled, disposable syringes to reduce the risk of overdose.

“This really takes the dosing risk out of the patient's hands,” Michael Botta, co-founder and president of Sesame, told USA TODAY.

“This is the first time we've felt comfortable with the idea of providing a compounded semaglutide offering to patients and physicians on Sesame, and that's why we're going to do it.”

How long will compounded semaglutide be available?

With sales of semaglutide dependent on shortages of brand-name products, time is running out for the drug. Novo Nordisk committed in January to doubling the amount of low-dose Wegovy available in the U.S. and said it would gradually increase supply throughout the year.

That worries patients like Lange. Given Wegovy's high prices, she will have to abruptly stop taking the weight-loss medication when the shortage ends and the compounded version is no longer available, Lange said..

Studies show that some patients regain some or most of their lost weight after stopping GLP-1 medications.

GLP-1 side effects:Dozens are suing Ozempic and other weight loss and diabetes drugs, claiming they have harmful side effects

Lange said her years-long supply of GLP-1 medication motivated her to lose weight and keep it off, but she worried the drugs would wear off and the “eating noises” that drove her to eat under stress might return.

“Everyone is kind of nervous that the rug is going to be pulled out from under us,” she said. “That worries me because it's working so well.”

You can get Ozempic alternatives online. What are the risks?

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