The regulator on Friday warned healthcare providers and patients about adverse events linked with dosing errors from compounded versions of Novo Nordisk’s weight-loss and diabetes drugs.
The FDA on Friday released an alert warning healthcare providers and the public about the potential safety risks associated with using compounded versions of Novo Nordisk’s semaglutide injectable products.
The regulator identified cases of dosing errors stemming from patients who self-administer these compounded semaglutide products. Healthcare providers also run the risk of “miscalculating” the appropriate dose, according to the FDA. In some instances, the adverse events resulting from these dosing errors have led to hospitalizations.
“There may be a risk of medication dosing errors due to conversion from milligrams to other units of measurement,” the FDA said. These compounded formulations could also come in different and varying concentrations and multiple-dose vials, which could introduce additional difficulties in determining the correct dose, according to the agency.
Common side effects from these compounded semaglutide products include fainting, headaches, dehydration, gallstones and acute pancreatitis. Patients also often reported gastrointestinal toxicities, such as vomiting, nausea warned and abdominal pain.
The FDA warned against the use of compounded semaglutide more broadly, noting that these reformulated therapies “pose a higher risk to patients” than approved medicines because they “do not undergo FDA premarket review for safety, effectiveness or quality.” Patients should only be on compounded medication if their “medical needs cannot be met by an available FDA-approved drug.”
Weight-loss therapies have been growing rapidly in recent months, with Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide) currently dominating the space and other competitors looking target the lucrative market.
Last month, data analytics firm GlobalData released a report estimating that obesity drugs could hit $111 billion by 2023. In May 2024, Reuters reported more optimistic forecasts from other experts with BMO Capital expecting the weight-loss market to reach $150 billion by the early 2030s, while Leerink projects a $158 billion value by 2032.
Still, a major obstacle for the market is supply. Unable to keep up with the public’s insatiable demand, several doses of Novo and Lilly’s weight-loss products have in recent months gone into intermittent shortages—though many of these have already been resolved.
Compounded drugs have risen to fill this gap in demand and supply. In June 2023, the FDA warned consumers that these reformulated products—which could contain salt forms of the base GLP-1 analog—may carry unintended and undocumented side effects. Earlier this year, the World Health Organization (WHO) also raised concerns about the prevalence of these compounded—and in some instances, counterfeit—weight-loss injections.
“Falsified medical products have been known to lack efficacy and/or cause toxic reactions,” the WHO said at the time, adding that patients with type 2 diabetes, who actually rely on GLP-1 receptor agonists to control their disease, are likely to suffer disproportionately from these products.
