People are excited to use semaglutide, a diabetes drug popular for assisting weight loss that's commonly sold as Ozempic and Wegovy — and there's good reason to be.
But the Food and Drug Administration is now warning the public not to get carried away, issuing an alert that it's received reports of people getting hospitalized after overdosing on the drug, in some cases taking up to 20 times the recommended dosage.
Some of the reported adverse effects included nausea, vomiting, abdominal pain, fainting, migraines, and acute pancreatitis, according to the agency statement, released last week.
The majority of these cases are accidental, and stem from patients using a compounded form of the drug, which leads to errors in self-administering injections.
This typically isn't an issue when using brand name semaglutide. Both Ozempic and Wegovy are sold as pre-filled injection pens, and other forms of semaglutide, like Rybelsus, are taken orally as tablets — so a proper, safe dosage is already prepared for patients.
Compounded drugs, on the other hand, are made using raw ingredients by pharmacies — not a drug manufacturer — typically so that it can tailor the product to a patient's specific needs. This is a legal but not FDA-approved practice, and it's not the first we've heard of trouble when patients get semaglutide from compounding pharmacies.
In several reports, pharmacies miscalculated the correct concentration of the drug, "which resulted in patients administering five to 10 times more than the intended dose of semaglutide," the FDA said.
In most cases, however, patient error was to blame. Because the compounded drugs were sold in multi-dose vials, patients had to draw up the correct injection dose themselves.
"Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and 'units') may have contributed to dosing errors," the FDA said.
The FDA recommends that you avoid using a compounded drug if an approved form of it is available.
But because they're cheaper, compounded drugs remain an appealing option. There are currently no generic versions of semaglutide, while brands like Ozempic and Wegovy can cost over $1,000 per month without insurance.
Both drugs have been blockbuster hits, in large part due to their appetite-suppressing effects that help with losing weight. Due to differences in their dosages, only Wegovy is officially approved for weight loss, but Ozempic is sometimes prescribed by doctors for this purpose "off-label."
The hype that has already seen global demand skyrocket has been further fueled by early signs that semaglutide could help people stop smoking and cure a host of other ailments. Manufacturer Novo Nordisk said that Ozempic sales rose more than 40 percent on the year in the first quarter, while Wegovy's more than doubled.
Needless to say, there's a lot of people trying to get their hands on semaglutide right now. So if you're one of the ones that does: please make sure you're taking it correctly.
More on semaglutide: Ozempic-Style Drug Slows the Progression of Alzheimer's Disease, Experiment Finds
Share This Article