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Some people taking off-brand Ozempic and Wegovy are seeking medical attention for dosing errors, the Food and Drug Administration warned.
The FDA issued an alert on Friday saying it had received adverse event reports regarding patients who overdosed on cheaper, injectable versions of compounded semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy.
When a medication is in shortage, the FDA allows pharmacies to make compounded, or altered, versions of the drug if they meet specific regulatory requirements. However, the agency does not review the safety and efficacy of these products.
“Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports,” the FDA said in its alert. “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.”
Additionally, the FDA found that instructions provided with the products instructed to users to administer the drugs in “units,” which could vary depending on the concentration, rather than milligrams or milliliters. These may have led some health care providers to prescribe the wrong dose.
In some cases, patients ended up taking doses five to 20 times larger than the intended dose and required hospitalization.
The overdose symptoms included nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, gallstones, and severe hypoglycemia (low blood sugar levels).
What is compounded semaglutide?
Compounding is the process of customizing an approved drug by a state-licensed pharmacist or physician to meet the specific needs of an individual patient.
Typically, the Food, Drug, and Cosmetic Act prohibits compounding drugs that are just copies of commercially available medications. However, drugs that are in shortage are not considered by the FDA to be commercially available.
The limited supply of highly coveted and expensive brand name drugs like Ozempic and Wegovy has spurred several telehealth platforms to take advantage of these section of the Food, Drug, and Cosmetic Act.
Telehealth platforms and online pharmacies like Hims & Hers, Ro and others offer weight loss drugs for hundreds of dollars cheaper than Ozempic’s nearly $1,000 list price and Wegovy’s $1,349 price tag.