Hims & Hers vs. Novo Nordisk: Are Compounded GLP-1s Safe?

Following Hims & Hers’ Super Bowl ad for its weight loss product, a debate has emerged over the safety of compounded GLP-1s for patients.

Compounded GLP-1s are custom-made by compounding pharmacies and include the same active-ingredient found in branded GLP-1s like Ozempic and Wegovy (semaglutide), but there are some important differences. As the public has become aware of the efficacy of these drugs, demand has soared amidst a shortage of the branded products. Companies of all stripes — digital health companies, medspas, plastic surgery providers and many others — have stepped up to meet the demand with compounded GLP-1s and create a new revenue stream.

On Friday, the FDA announced that the shortage of semaglutide injectables, which began in 2022, is over. This may slow down the prescribing of the compounded version of these drugs, but the issue of safety is not going to be resolved any time soon.

But it’s especially important to understand the issues given how broadly viewed a Super Bowl ad is.

The Hims & Hers ad states that obesity is America’s “deadliest epidemic” and declares the healthcare system was built to keep patients “sick and stuck.” It also notes that there are medications that work, but are priced “for profits, not patients.” Though the ad doesn’t explicitly name any drugs, the message is clear: Buy Hims & Hers’ weight loss offering, which may include weight loss medications like compounded GLP-1s and a treatment plan designed by a doctor.

In response to the Hims & Hers TV ad, Novo Nordisk — the manufacturer of Ozempic and Wegovy — put out a print ad in the New York Times and USA Today stating, “Do you really know what you’re injecting into your body?” It then states that compounded GLP-1s are not FDA-approved and are not proven safe or effective.

In a statement to MedCity News, a Novo Nordisk spokesperson said the company is “deeply concerned about irresponsible advertising by companies like Hims & Hers that use misinformation and mislead the public to drive sales of non-FDA approved, knockoff versions of GLP-1 medicines under the pretext of doctor trust and affordability. In addition, these advertisements fail to provide basic information about the appropriate patient populations and risk/benefit profiles of their offerings.”

If a Hims & Hers provider prescribes a compounded GLP-1, patients receive a step-by-step tutorial on how to inject the medication, along with 24/7 messaging with a provider. The company can also prescribe Ozempic and Wegovy, oral medications and meal replacement kits.

It’s important to note that Hims & Hers isn’t the only digital health company offering access to compounded GLP-1s. Ro, WeightWatchers, Noom, Sesame and many others have jumped on the bandwagon — for instance, plastic surgery companies.

There are only two situations in which compounded medications can be prescribed, one of which being a shortage of an FDA-approved drug, according to Tenille Davis, chief advocacy officer of the Alliance for Pharmacy Compounding (APC), an advocacy organization for compounding pharmacies. The other scenario where a compounded version can be prescribed is if an FDA-approved drug is not appropriate for a patient. For instance, if someone has an allergy and needs a custom formulation.

Now that the shortage is over, compounded versions of semaglutide can only be prescribed if the patient requires a dosage form or dosage strength or combination drug that includes semaglutide but is not commercially available. The FDA also provided a transition period for when pharmacies and providers need to move their patients to branded GLP-1s (60 days for state-licensed pharmacy or physician compounding and 90 days for outsourcing facilities), according to APC.

In a statement on X, Hims & Hers CEO Andrew Dudum said the company “will continue to offer access to personalized treatments as allowed by law to meet patient needs,” referring to compounded semaglutide.

The question over safety of these drugs remains, though one Hims & Hers executive pointed to the fact that people have historically used compounded-pharmacy drugs.

“Compounding has been out for years,” said Dr. Craig Primack, senior vice president of weight loss at the company, in an interview.

Davis of APC echoed Primack.

“Compounding pharmacists have been creating these kinds of copies for drugs and shortages for decades, hospitals get these kinds of shortage drugs compounded all the time,” Davis said. “Last year, there was a shortage of amoxicillin and ibuprofen and acetaminophen in children’s suspensions, and pharmacists were compounding copies of those then. But that didn’t get any media attention because it doesn’t have the public interest that GLP-1s have. … It’s something that’s been happening in compounding pharmacies ever since their creation.”

Primack of Hims & Hers noted that the company is following the rules closely and taking care of its patients.

“We are doing everything within the rules that are placed to give a comprehensive approach to weight management and weight care for all of the patients on our platform,” he said.

One such rule is that compounding pharmacies must use pharmaceutical-grade ingredients, and compounding is subject to provisions regarding insanitary conditions.

Still, an obesity physician remains unconvinced.

“Right now, we have zero safety or efficacy data on compounded agents,” said Dr. Disha Narang, an endocrinologist and director of obesity medicine at Endeavor Health, in an interview. “We have no FDA approval of these agents. And quite frankly, I don’t know what patients are pumping into their bodies with these compounded substances. And so for that to be marketed at a large scale is deceptive.”

It’s a matter of patient access and affordability to an effective drug

Hims & Hers, which began offering compounded GLP-1s in May 2024, charges consumers $165 per month. This compares to Ozempic, which has a list price of $968.52, and Wegovy, which has a list price of $1,349.02. Some patients may be able to get the branded drugs covered by insurance, though coverage varies by the insurance provider.

“Accessibility is very important to the world of obesity. … The problem is we have a lot of treatments that we can have success with in our country, [but] we don’t have a lot of ways right now with the branded drugs to have access,” Hims & Hers’ Primack said.

He added that the company ensures safety in several ways. It uses 503B compounding pharmacies versus 503A compounding pharmacies. The former is regulated by the FDA, whereas the latter is only regulated by the state board of pharmacy. In addition, each batch of compounded GLP-1s gets analyzed for contaminants, bacteria or viruses.

Along with the compounded drug, the company provides consumers access to a physician through messaging, educational resources, as well as nutrition and exercise support. According to a white paper that Hims & Hers did on its weight loss program, fewer than 20% of patients have reported major side effects and only 13% discontinued treatment in the first month.

WeightWatchers, a weight management company, also provides access to compounded GLP-1s starting at $129 for the first month and $189 for each additional month. Its clinical offering connects patients with a certified clinician specialized in obesity care, who may prescribe GLP-1s if a patient is considered eligible. The clinician may also prescribe branded GLP-1s.

With compounded versions, WeightWatchers implements several precautions that appear to be similar to Hims & Hers, a company executive stressed.

“WeightWatchers Clinic prioritizes patient safety by only prescribing compounded GLP-1s from FDA-registered 503B outsourcing facilities, which follow stringent manufacturing requirements,” said Dr. Jamil Alkhaddo, medical director of WeightWatchers, in an email. “These facilities source ingredients from FDA-registered suppliers and adhere to [current good manufacturing practice] regulations for quality, potency, and sterility. Additionally, our compounded medications undergo third-party batch testing for potency, sterility, bacterial endotoxicity, particulate matter, pH, and appearance, verifying they meet required specifications.”

Besides offering access to compounded GLP-1s, WeightWatchers also offers patient education, dosing guidance, smaller syringes to prevent overdosing, monthly clinician check-ins and access to full-time registered nurses.

Like WeightWatchers, Sesame, a telehealth company, also provides access to compounded GLP-1s and branded GLP-1s if patients are eligible. However, President and Co-founder Michael Botta understands the concern with compounded GLP-1s.

“Where I have the most concern is that a lot of these platforms are treating the medical care part of prescribing medically-assisted weight loss therapy as almost like a check-the-box exercise,” he told MedCity News. “They’re having you fill out a survey, or they’re doing purely asynchronous care, and they’re not having you actually speak live to a trained clinician or a physician who knows how to prescribe, how to manage a patient who’s appropriate, what the guidelines are, how to manage side effects.”

Hims & Hers is an example of a company providing asynchronous care, Botta pointed out. By contrast, Sesame patients have live, ongoing treatment with their physicians. The company also uses 503B compounding pharmacies.

Hims & Hers responded to the Sesame executive’s criticism of asynchronous care by arguing that this very model allows patients to have more frequent and ongoing communication with providers. The company noted that traditional primary care appointments can take over 20 days to schedule. In addition, studies show that asynchronous care improves access and is easily implemented by clinical teams, a company representative said.

FDA’s concerns

The FDA has published several concerns with compounded GLP-1s, emphasizing that they’re not FDA approved, though they might be appropriate if a patient’s medical need can’t be met with an FDA-approved drug. For example, there have been several reports of adverse events and hospitalizations from dosing errors with compounded versions, the agency noted. These errors have occurred from patients self-administering incorrect doses of the drug or healthcare professionals “miscalculating” doses of the drug.

A November report from CNN showed that compounded versions of semaglutide have been associated with at least 100 hospitalizations and 10 deaths.

Narang of Endeavor Health said she frequently has patients come to her for care after being on compounded GLP-1s. Her patients who have stopped taking these compounded medications often cited that they haven’t lost weight on it, plateaued much quicker or weren’t getting adequate counseling to be successful on the medication. While telehealth platforms may say they’re coupling GLP-1 prescriptions with support from clinicians, they’re often just providing quick zoom or phone calls, she declared.

She added that these compounded GLP-1s are often mixed with various supplements like B12, but there is “zero data” on the efficacy or long-term safety or weight loss for doing this. She also argued that many compounded versions have impurities and severe side effects, like nausea, vomiting and pulmonary embolism.

“I don’t fault [patients] for seeking out something to finally address something that they may have been dealing with for all these years,” Narang said. “What I do find fault with is a lot of these other entities, whether it’s these telehealth companies or med spas, they’re taking advantage of people’s desperation to lose weight. … What’s actually more concerning to me is [that patients previously taking compounded GLP-s] had no idea that there were all these risks associated with the compounded agents that they were taking.”

Novo Nordisk also voiced concerns about those selling compounded semaglutide.

“The truth is that when it comes to those selling knockoff semaglutide, whatever is in their vials is not FDA-approved and potentially unsafe,” said Jamie Bennett, a spokesperson. “Not knowing what is inside a product that is being marketed as a medication is a gamble no patient should ever have to risk.”

Bennett added that “knockoff offerings” aren’t evaluated by the FDA or any government agency. In addition, some samples have been discovered to have impurities and FDA-banned substances, as well incorrect amounts of the core ingredient.

Narang is also concerned that these telehealth companies prescribing compounded GLP-1s are not valuing chronic care and are treating obesity as a “disease of vanity.” While the companies may say they value chronic care in their commercials, many patients that come to her from telehealth companies report not receiving adequate follow-up, she said. They are also being told to restrict their calories or take supplements for weight loss, not ideal advice according to Narang.

“Not a single one of those things has been deemed to be successful long term, because severe caloric restriction is very, very hard to sustain long term,” she said.

Photo: sdecoret, Getty Images