Compounded Versions Of Weight Loss And Diabetes Drugs Led To Death And Hospitalization, Novo Nordisk Says It Is Aware

Earlier, Novo Nordisk A/S NVO petitioned the FDA to ban compounding pharmacies from producing cheaper, unapproved versions of its drugs Wegovy and Ozempic.

Amid shortages and rising demand for branded drugs, compounded semaglutide has gained popularity due to its affordability.

However, Novo Nordisk contends that only FDA-approved versions should be available, emphasizing the safety risks associated with compounded drugs.

Novo Nordisk’s Chief Financial Officer Karsten Munk Knudsen has reportedly confirmed that the company was aware of at least ten deaths and 100 hospitalizations linked to these compounded versions of semaglutide-based drugs.

Also Read: Eli Lilly Sues Some Vendors For Unauthorized Sale Of Fake Weight-Loss Drug

However, he noted that no definitive cause of death is identified in the reports, as the data is pulled from the FDA adverse events database.

Last week, the update came as the FDA revised its shortage list to note that the .25 mg starter dose of semaglutide-based obesity med Wegovy is now available in the U.S.

Less than a month ago, the FDA removed Eli Lilly And Co’s LLY tirzepatide from its shortage list.

Soon after the shortage was resolved, the FDA reminded compounders of the legal restrictions on making copies of FDA-approved drugs. The update has sparked concern among medical professionals, patients, and drug compounding facilities.

A company spokesperson referred Reuters to the FDA’s database, which tracked these events over the past two years. Adverse event reports, which are submitted by doctors, patients, drugmakers, and others, are primarily used as an early warning system.

These reports are not considered conclusive evidence of causality and often lack important details. Furthermore, it is possible that multiple submissions may describe the same incident.

Knudsen also discussed the company’s ongoing efforts to address safety concerns related to compounded versions of its drugs.

He mentioned that Novo Nordisk has been monitoring the market for compounded products and has identified several safety issues.

Novo Nordisk argues that these compounded versions may pose safety risks, such as impurities and incorrect dosages, and sometimes lack the active ingredient entirely.

On Wednesday, Novo Nordisk released Q3 earnings. “Following higher-than-expected volume growth in recent years, including GLP-1-based products such as Ozempic and Wegovy, combined with the expectation of continued volume growth and capacity limitations at some manufacturing sites, the outlook also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies,” it added.

Price Action: NVO stock is up 1.59% at $107.04 at the last check on Thursday.

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