SILVER SPRING, Md. — The U.S. Food and Drug Administration on Friday warned patients and doctors about a medication error involving a Novo Nordisk combination weight-loss and diabetes drug.
Health officials said they have received reports of adverse events, some requiring hospitalization, that may be related to overdoses caused by patients accidentally self-administering compounded medication and health care workers miscalculating dosages.
The FDA warned that the use of compounded drugs poses high risks to patients, as compounded drugs may contain additional ingredients that could lead to medication errors. The FDA urged health care providers and compounders to provide appropriately sized syringes and instruct patients on how to measure the dosage.
Taking too much of these medicines can cause side effects such as severe nausea, vomiting, and low blood sugar.
The explosive demand has created major shortages and a booming global market in cheaper, and sometimes counterfeit, versions.
The FDA has also expressed serious concerns about counterfeit versions of other drugs approved for weight loss, including Novo’s diabetes drug Ozempic, as well as Novo’s Wegobee and Eli Lilly’s Zepbound.
Semaglutide, the active ingredient in Wegovy and Ozempic, belongs to the GLP-1 class of drugs that help control blood sugar levels and induce satiety.
Novo’s Wegovy is available as a single-dose prefilled pen that delivers doses designed for once-weekly administration, while Ozempic is available as a single-patient, multi-dose prefilled pen designed for once-weekly administration.
