12 March 2024Big PharmaLiz Hockley

Ozempic counterfeits prompt Novo Nordisk to join forces with authorities

Danish drugmaker testing suspect products and assisting with legal cases | High demand and global shortages have driven surge in weight-loss drug fakes.

Novo Nordisk has said it is taking reports of patient harm resulting from fake versions of diabetes medicine Ozempic “very seriously” and working with authorities in several countries to tackle the problem.

Counterfeit versions of the drug have been detected in 16 countries to date, according to the Partnership for Safe Medicines, Reuters reported on Friday (March 8).

Novo Nordisk CEO Lars Fruergaard Jørgensen told Reuters that the prevalence of counterfeits was something the company took “very seriously”.

“We cannot take action on our own,” he said. The Danish drugmaker has been collaborating with authorities to test suspect products and assist with legal cases.

Off-label use

Demand for Ozempic, which has an active ingredient of semaglutide, has been soaring as people have been using it off-label for weight loss—including some celebrities.

Semaglutide mimics a naturally occurring hormone that helps regulate blood sugar and appetite, and is approved for weight loss under the name Wegovy.

The increased use of Ozempic for weight loss has led to shortages in countries including the UK, Germany, Belgium and the US, and a rise in counterfeits.

Wegovy is available on the NHS for obesity and weight-related problems. However, the use of Ozempic for weight loss has led to shortages in the UK for type-2 diabetes patients, with the government monitoring the situation.

Skyrocketing sales of Ozempic and Wegovy have catapulted Novo to become Europe’s most valuable company in terms of market capitalisation, which reached $428bn last September—the same month that Wegovy was introduced to the UK.

Novo announced in November last year that it would spend $6 billion by the end of 2029 to expand its manufacturing site in Denmark, predominantly to boost the output of active pharmaceutical ingredients (APIs) including semaglutide.

Side effects of counterfeits

Hypoglycemia can be a serious side effect of taking fake versions of Ozempic, according to reports made by Novo to the US Food and Drug Administration (FDA).

In one reported case, a woman suffered a seizure and ended up in a diabetic coma after taking counterfeit Ozempic to lose weight.

The FDA issued a warning to consumers in December last year not to use counterfeit Ozempic found in the supply chain, stating that it could not confirm the sterility of the needles from certain seized products which presented an increased risk of infection.

Compounded semaglutide is also a problem in the US, with the APIs coming from unregulated facilities.

Reuters reported that one person died last year from abnormal blood clotting after taking a drug advertised as compounded semaglutide, and that other consumers had suffered severe vomiting and nausea, sensory loss in the legs, and a drop in blood platelet levels.

The FDA stated on its website that “patients and healthcare professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness of quality”.

In April last year, the agency expressed concern at reports of salt forms of semaglutide being used in compounded versions of the drug, which it said were “different active ingredients than is used for the approved drugs”.

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