FDA warns of adverse events due to overdosing of compounded semaglutide
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Key takeaways:
- The FDA said some people using compounded semaglutide have experienced adverse events tied to overdosing.
- Lack of dosing experience and errors with converting measurement units may lead to overdosing.
The FDA is warning providers and patients that dosing errors with compounded injectable semaglutide may be leading to adverse events, according to a press release.
The FDA has received reports of adverse events, some of which led to hospitalization, that may be tied to overdosing with compounded semaglutide. The agency stated the overdosing may be due to a lack of experience with self-injections among patients, unfamiliarity with withdrawing medication from a vial to a syringe and confusion with different units of measurement.
In the release, the FDA noted compounders offer injectable semaglutide in different containers and packaging, and concentrations of the medication may vary between compounders. In the majority of reports, patients said they mistakenly drew five to 20 times more than the prescribed dose during self-administration. Patients stated they were unfamiliar with how to measure the intended dose using a syringe, in most reports.
Some instructions with compounded semaglutide direct users to administer it in units rather than milligrams or milliliters, according to the release. In some reports, providers stated they incorrectly calculated the intended medication dose when converting from milligrams to units or milliliters. This led to some patients administering five to 10 times the intended dose of semaglutide.
Some of the adverse events reported to the FDA tied to compounded semaglutide include gastrointestinal events, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.
The FDA has approved three forms of semaglutide (Ozempic/Rybelsus/Wegovy, Novo Nordisk) for the treatment of type 2 diabetes and obesity. FDA-approved injectable semaglutide products are all dosed in milligrams, have standard concentrations and are only available in pre-filled pens. Compounded semaglutide poses a higher risk for patients than FDA-approved medications as these products do not undergo FDA premarket review for safety, quality or effectiveness, according to the release. The FDA said it advises patients to use compounded drugs only if their medical needs cannot be met by an FDA-approved medication.
The release is the latest warning from the FDA about compounded semaglutide. As Healio previously reported, the agency issued a warning about compounded salt forms of semaglutide in 2023 due to a potential risk for adverse events.
The FDA said people using compounded semaglutide should speak with a provider or compounder about measuring and administering the proper dose of compounded semaglutide. The FDA also advised providers to be vigilant when prescribing and administering compounded semaglutide due to variability between products.
Patients, providers and compounders are asked to report adverse events and medication errors associated with compounded semaglutide to the FDA’s MedWatch Adverse Event Reporting program by submitting a report online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or submitting the form at https://www.fda.gov/media/85598/download?attachment and faxing it to the FDA at 1-800-FDA-0178.
Perspective
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Susan Cornell, PharmD, CDE, FAPhA, FAADE
GLP-1 receptor agonists were first introduced in 2005 and approved for the treatment of type 2 diabetes. Then, a decade later, some drugs in this class received approval for obesity. Despite the fact that GLP-1s have been available for nearly 2 decades, their popularity did not explode until the past few years. The growth in GLP-1 receptor agonist use is primarily due to its weight loss advantages.
Social media and non-health care influencers created an enormous buzz around the weight loss benefits of GLP-1s, specifically semaglutide and tirzepatide (Moujaro/Zepbound, Lilly). This generated such a high demand for specific GLP-1 medications that a drug shortage occurred. Many people who relied on GLP-1s to manage their diabetes were no longer able to get their prescribed medications due to other people looking for cosmetic improvements.
When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug and Cosmetic Act. However, this drug shortage has resulted in pop-up companies starting their own compounding processes to manufacture non-FDA-approved GLP-1 receptor agonist products — meaning these non-pharmaceutical companies are compounding products with little to no oversight. In essence, they are producing counterfeit GLP-1s, which may have harmful effects to an unaware consumer.
It is good to know that the dangerous side effects of these counterfeit products are finally being acknowledged and receiving media attention in hopes to educate the public. Health care providers need to inform and educate their patients about the importance of receiving a quality product from a reputable source, such as their community pharmacy. Online products that do not require a prescription, products sold by illegal pharmacies and those prescribed by a health care professional who does not take a complete and thorough medical history should be avoided.
Bottom line is consumer beware: A quick fix for weight loss does not come from online, illegal, counterfeit drugs.
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