You’ve heard the catchy commercials. You’ve read the news coverage. You might even have personal experience. The mainstream awareness and conversation about using prescription medications for diabetes and obesity are nearly impossible to ignore.
But did you also know that counterfeit and compounded versions of these injectable medicines are increasing in sales, threatening the health of patients and the safety of the U.S. drug supply?
A study published recently in JAMA Network Open exposed the reality that nearly half of online pharmacies selling weight-loss drugs are doing so illegally — without licenses or patient prescriptions. The FDA also just released an alert about “adverse events, some requiring hospitalization” related to dosing errors associated with compounded weight-loss products.
Unfortunately, I’m not surprised.
In my work as a pharmacist and board member for the Partnership for Safe Medicines, I’ve researched dangers and followed expert warnings about the rise in third-party interference as demand for prescription weight-loss medications has far exceeded supply.
Policymakers must reassess the regulatory landscape, and authorities must continue to educate the public, because just like the popularity of weight-loss medicines, the safety concerns show no signs of abating.
Few medicines have experienced such enormous growth as these diabetes and obesity injectables. According to recent research, at least 92 percent of physicians have prescribed them on an active basis. Not surprisingly, there have been challenges keeping up with the demand.
That’s how the bad actors capitalize.
Counterfeit drugs have long been a global problem, but the fervor around weight-loss medicines — and shortage in availability to fill — has created unique loopholes for bad actors like counterfeiters and less reputable compounding pharmacies to exploit.
Earlier this year, one cybersecurity firm identified and took down over 250 websites selling counterfeit versions of popular weight-loss drugs. Over the last two years, the FDA has also received reports of U.S. consumers experiencing throat and facial swelling and loss of consciousness after taking counterfeit Ozempic. Some patients have even given themselves life-threatening injections of insulin that were disguised to look like one of the weight-loss treatments.
The risks extend to compounding, too. Throughout the U.S., about 7,500 pharmacies are licensed to make compound drugs. This means they can combine, mix or substitute ingredients to create alternate versions of medications in an attempt to meet demand. On the surface, this seems like a perfect pathway for those seeking accessible alternatives to popular weight-loss drugs.
But the peril is in inspection and regulation. Pharmacy-created drug compounds are not as carefully monitored, and some have included ingredients the FDA has not approved. In the rush to take advantage of the money in this space, it is tempting to cut corners.
Sterile conditions are also a major concern for compounding in the past. There have been incidents of severe illness and death from compounded products, including a large-scale fungal meningitis outbreak that resulted in more than 100 deaths.
And the lack of serial numbers on compounded medicines makes tracing and safety more difficult.
The FDA has taken note, issuing multiple warnings about compounded diabetes and weight-loss injectable drugs that contain impermissible ingredients or cause other harms. It’s also why the FDA recommends never using a compounded medicine if the agency-approved one is available.
Experts across government agencies and throughout the pharmaceutical landscape clearly recognize the urgent problems with counterfeits and compounds.
But patients and the public deserve more.
Authorities need to use every resource available to steer people away from counterfeit and compounded versions. Deliver a clear message: Those pursuing weight-loss medications should only do so directly from an FDA-approved source after receiving a prescription from a reputable medical professional. Do not buy them outside a pharmacy or from unregulated online platforms like Etsy. The latter point might seem obvious, but the Partnership for Safe Medicines has tracked the sale of compounded weight-loss injectables on Etsy, which is most definitely not a pharmacy.
Then, policymakers must conduct a thorough examination to better limit avenues for counterfeits and poor compounds to reach consumers. This must include harsh punishments for those who purposefully endanger patients.
This action and anti-counterfeit education should become as prominent as the weight-loss medicines themselves.
Dr. Kenneth McCall is a pharmacist, clinical professor, and on the board of the Partnership for Safe Medicines.