Virtual health and wellness platform Hims & Hers Health, Inc. is now offering an injectable weight loss drug with the same active ingredient (semaglutide) as Novo Nordisk’s popular brand-name injectables Ozempic and Wegovy—at an 85% discount, announced the company. For $199 a month, customers can receive the Hims & Hers glucagon-like peptide-1 (GLP-1) injectable, unlimited virtual consultations, and 24/7 access to a licensed medical provider, according to the company.
The semaglutide injectable by Hims & Hers is a compounded drug, a customizable type of pharmaceutical not approved by the U.S. Food and Drug Administration (FDA). Read on to learn more about compounded drugs, the details about Hims & Hers GLP-1 injectables, and what the discounted offering means for drug shortages.
What Is a Compounded Drug?
Compounded drugs are like those special cocktails your pharmacist or doctor whips up just for you. They tweak and mix meds to suit your personal needs, like if you’re allergic to a certain ingredient or if you need a different dose that makes you feel more comfortable. It’s all about tailoring the treatment to fit you perfectly!
Individual and small-scale compounded drugs, you know, the ones you get with a scribbled note from your doc, are whipped up at these local spots called 503A compounding facilities. They’re like the mom-and-pop pharmacies you might find in your neighborhood or even in a hospital. Now, if you need a bigger batch of these meds, there are these larger 503B outsourcing places that have the FDA’s stamp of approval. They can make a bunch of these drugs without needing a prescription for each one. It’s like they’re the big-time drug wholesalers for special orders. They can cook up stuff that’s in short supply, like semaglutide and other GLP-1 injectables, which are basically the same or really close to the ones on the FDA’s “we’re running low on these” list.
Are Compounded Drugs FDA Approved?
Compounded drugs aren’t FDA-approved. . However, when a drug like semaglutide ends up on the FDA’s shortage list, they ease up on the rules a bit. Normally, companies can’t just whip up copies of drugs that are already approved. But in this case, they give the green light to make replicas. Why? So more people can get their hands on the meds they need. It’s like when a popular toy is sold out everywhere, but then some other companies start making similar ones to keep up with the demand.
While compounded meds might be a lifesaver for some folks who can’t take the usual FDA-okayed stuff or when there’s a shortage of their regular drugs, they can be a bit riskier, ya know? The FDA says these custom-made mixtures might not be as safe or top-notch quality as the drugs that go through all those tough tests and get their stamp of approval.
Are Compounded Semaglutide Injectables Safe?
“I do not back the idea of using compounded semaglutide,” explains Adrienne Youdim, who’s on the Forbes Health Advisory Board and is totally into helping people shed those extra pounds with medical weight loss and good ol’ nutrition. “You see, these compounded drugs don’t get the same eagle-eye treatment from the FDA like the others do. Basically, they’re not under the same strict watch as regular meds. So, they kinda slide under the radar a bit, you know?” So, we’re not really sure about all the stuff that’s in there and how they’re made, which isn’t exactly comforting, ya know?”
In 2023, the FDA had to put out a heads up about these homemade GLP-1 semaglutide shots because they started getting a bunch of complaints about people having some not-so-fun side effects and weird things happening to them after using them.
Further, some mixes of semaglutide might have the salt version of the main stuff, unlike what’s in Wegovy and Ozempic. And, guess what? That salt form hasn’t really been proven to work well or be totally safe for dealing with either diabetes or helping people lose weight.
Hims & Hers Compounded GLP-1 Injectable
Hims & Hers semaglutide injectables contain the same active ingredient as Wegovy and Ozempic, both of which are FDA-approved drugs commonly used for diabetes and weight loss. The injectable is basically a weekly thing you use as part of a bigger plan to shed those extra pounds. It’s not just about popping a shot, but also making some changes to what you eat and how you live your life. The Hims & Hers semaglutide injectable is not FDA approved.
“All of our offerings are delivered using the current clinical guidelines,” says Patrick Carroll, M.D., chief medical officer of Hims & Hers. “For our thing to help you shed those extra pounds, we’re totally down with the latest body mass index (BMI) tips: We’re talking to folks who have a BMI of 30 or more (and if you’re at 27 but dealing with some extra stuff, like health issues, we’ve got you too)!comorbidities) are eligible for [our] GLP-1 [injectables].”
The $199 per month subscription to the Hims & Hers compounded injectable involves a close follow-up process and unlimited medical consultations with a licensed provider. The drug isn’t something you’d use to manage diabetes, says Dr. Carroll.
To enhance safety, the company’s teaming up with a manufacturer that’s got the FDA’s stamp of approval for their 503B outsourcing spot, which means it’s under the watchful eyes of both state and federal folks, the guy says.
GLP-1 Injectables for Weight Loss
GLP-1 drugs are like the cool kids on the block for helping with type 2 diabetes and weight issues. They work by giving your body a little nudge to make more insulin, which is like the VIP pass for sugar to get into your cells and keep your blood sugar from throwing a wild party. And if you take a bit more of these drugs, they can also be like a hunger whisperer, making you feel full and happy so you don’t eat as much. It’s like they’re giving your metabolism a high-five to keep everything running smoothly!
“It’s important to keep in mind that obesity is like a never-ending battle, and dealing with all the health stuff that comes with it is a marathon, not a sprint,” Dr. Youdim points out. “So, even if you hold off on starting those semaglutide meds like Ozempic or Wegovy for half a year, it’s not gonna make a huge difference in the grand scheme of things for your treatment journey.”My recommendation would be to wait [for FDA-approved drugs to become available] rather than use unapproved formulations,” she adds.