Instead, she went with a compounded semaglutide, a medication that has the same active ingredient as Wegovy and Ozempic but lacks approval from the U.S. Food and Drug Administration.
The 59-year-old from Columbus, Ohio, said getting the drugs online was easy. There were a “bazillion companies” to choose from; all she needed to do was complete a questionnaire and have a phone call with her chosen telehealth provider. Minor side effects like nausea haven’t been fun, but she’s down 12 pounds after one month.
“For me, it’s been a good experience,” said Lange, who pays about $200 a month for her yearlong prescription.
There are other success stories like Lange’s, people who found compounded drugs to be an affordable, accessible substitute amid the brand-name shortage. But some health experts are sounding alarms about the risks associated with the alternative medications.
Rebekah Carl injects herself with her weekly dose of Wegovy in New Columbia, Pennsylvania, U.S., November 13, 2023. REUTERS/Hannah Beier Hannah Beier, Reuters
What is compounded semaglutide?
When there is a shortage of FDA-approved, brand-name medication – like with GLP-1 drugs Ozempic and Wegovy – the FDA says it allows compounding pharmacies to make alternative medications 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 compounding pharmacies are generally regulated by state boards of pharmacy and source ingredients from FDA-registered facilities, but the agency does not verify their drugs’ safety, effectiveness or quality.
Novo Nordisk – the company that makes Ozempic and Wegovy – has made clear it "does not directly or indirectly provide or sell bulk semaglutide to compounding pharmacies," and the FDA in January said it received reports of some compounders 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 compounding pharmacies are more reputable than others, but “there's no guaranteeing that it has that same rigorous safety profile,” said Dr. Diana Thiara , medical director of the University of California, San Francisco’s weight management clinic and an assistant clinical professor of medicine.
“We never recommend compounding to patients, from a safety standpoint,” Thiara said.
As of July 15, the FDA has received reports of more than 31,000 "undesirable experiences" thought to be associated with a semaglutide product. Data from the agency's Adverse Event Reporting System (FAERS) shows more than 280 of those were associated with compounded drugs said to contain semaglutide, although the figure may be an undercount because some reports were submitted by patients who may not recognize or report that their medicine is a compounded drug.
Another concern is ease of access. Some online providers require a phone call or video consultations with a provider, but getting a GLP-1 prescription online doesn’t always require proof of body mass index or lab tests. That could make it easier for patients to falsify information, according to Thiara.
“There’s nothing onerous to prove that this is a medication that, medically, would be helpful to somebody,” she said.
And not every online pharmacy operates legally. The National Association of Boards of Pharmacy, a nonprofit that represents state pharmacy regulators, has identified more than 40,000 online pharmacies that don’t comply with patient safety standards or laws.
Novo Nordisk found evidence of compounded drugs with impurities or no semaglutide, according to a news release in May . The drug manufacturer has filed multiple lawsuits to try to stop medical spas, weight loss clinics and compounding pharmacies from unlawfully selling the compounded drugs.
But there are compounding pharmacies operating legally, and advocates argue these drugmakers play an important role by offering alternatives amid the brand-name shortage.
FDA-approved drugs “should always be the first choice” when available, but a compounded drug can be a safe alternative and should not be conflated with illegal counterfeits , according to Tenille Davis, chief advocacy officer for the Alliance for Pharmacy Compounding, a trade group for pharmacy compounders.
So long as patients are obtaining prescriptions from legitimate medical prescribers and taking drugs dispensed from legitimate compounding pharmacies, “there are regulatory frameworks in place to make those as safe as they can be,” Davis said.
Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy in London, Britain March 8, 2024. Hollie Adams, Reuters
Are there overdosing risks?
Unlike Ozempic or Wegovy, which come in prefilled pens, compounded semaglutides are often administered in vials that patients measure themselves. The FDA issued a warning earlier this year about dosing errors leading to "adverse events, some requiring hospitalization."
As of June 30, there have been 159 calls to U.S. poison control centers involving compounded GLP-1s, according to America’s Poison Centers. That’s roughly 4% of the 3,866 calls related to all GLP-1 medications in that time frame, but it’s up from the 32 compounded GLP-1 exposure calls in all of 2023.
“A lot of those cases are related to people trying to use (the drug) therapeutically and making a mistake with administering the medication,” said Kait Brown, clinical managing director of America’s Poison Centers.
Brand-name weight loss medications can cause nausea and digestive problems , and overdosing on compounded semaglutide can lead to similar – and sometimes more serious – side effects like nausea, vomiting, fainting, dehydration, acute pancreatitis and gallstones, according to the FDA.
And because it takes about a week for half of the drug to clear from a patient's body, potential side effects from overdosing can linger.
"Let's say you take too much and you're feeling really nauseous, or you are throwing up," Thiara said. "That side effect is going to be there for a while."
Lange – a former medical assistant – said even she had trouble figuring out how to measure her first shot from Hims & Hers, a telehealth provider initially focused on erectile dysfunction medications and hair loss treatments. Lange said she was able to clear things up after a call to a customer service line.
Hims & Hers Chief Medical Officer Pat Carroll said the company offers educational resources 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 includes a list of up to 100 questions reviewed by a licensed provider and, in certain cases, a video call.
“There's still a major issue with the price of these meds and the availability of them, and high-quality, compounded medications on a platform like ours really has a role in terms of affordable access,” Carroll said.
Ro, another popular telehealth company, has an intake process that includes a questionnaire on medical history and goals and a required photo or virtual visit. A Ro-affiliated provider reviews the patient's information and may order a lab test “if more information is needed,” according to the company’s website .
If patients have questions or need support, they can schedule a coaching session with a nurse or connect with their provider or pharmacist, according to Ro spokesperson Nicholas Samonas.
Health care marketplace Sesame, one of the latest companies to offer compounded semaglutides, requires a face-to-face consultation with a provider and offers its product in prefilled, single-use syringes to lower the risk of overdosing.
“It really takes the risk of dosing out of the hands of the patient,” Sesame co-founder and president Michael Botta told USA TODAY.
“This is the first time that we have felt comfortable with the idea of making a compounded semaglutide offering available to patients and clinicians on Sesame, and so we're going to do it.”
How long will compounded semaglutides be available?
Because compounded semaglutide sales hinge on the brand-name shortage, the clock is ticking down for the drugs. Novo Nordisk in January committed to doubling the amount of lower-dose Wegovy available in the U.S. and said it would gradually increase supply throughout the year.
That has patients like Lange worried. With Wegovy’s high prices, Lange said she’d have to cut weight loss medication cold turkey if the shortage ends and the compounded version is no longer available .
Studies show some patients regain some or most of the weight they lost after getting off GLP-1 medications.
Lange said she’s motivated to shed weight with her yearlong supply of GLP-1 drugs and keep it off, but she worries about the drugs going away and the return of the “food noises” that pushed her to eat when stressed.
“Everybody is kind of on edge that the rug is going to be taken out from under us,” she said. “That is a concern of mine because it’s working so well.”
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