Life-threatening effects caused by counterfeit Ozempic pens detected in Australia prompting TGA warning

Counterfeit Ozempic pens, which appear to be relabelled insulin pens, have been detected in Australia and have caused a life-threatening drop in blood sugar levels in at least one user — and others are now being warned.

The Therapeutic Goods Administration issued a public health alert including warning signs for consumers to spot the fake medicine.

Ozempic is typically used to treat type 2 diabetes but its unapproved and off-label use to assist with rapid weight loss has caused a surge in demand and subsequent drop in supply levels, leading to the increased introduction of Ozempic alternatives.

The genuine medicine is a once-a-week injectable prescription medicine, designed to be used alongside diet and exercise, to regulate blood-sugar levels and manage the risk of heart attacks and stroke.

Its active ingredient, semaglutide, controls insulin secretion from the pancreas but has also been found to suppress appetite receptors in the brain.

All the counterfeit products “appear to be relabelled insulin pens” which is a different, and sometimes dangerous, type of medicine, according to the TGA.

“The pens are currently undergoing laboratory testing. However, as the safety, quality and efficacy of these products are unknown they may pose a serious health risk and should not be used,” the TGA said.

“We have received one report of a life-threatening adverse event in Australia.

“Similar counterfeit products identified overseas have been associated with life-threatening adverse events, including hospitalisation, due to insulin being unknowingly injected instead of the expected semaglutide.”

The TGA said the pens which caused the nearly-fatal reaction — labelled with batch number JS7A925 — were ”bought overseas”.

The Australian Border Force has also “detected counterfeit Ozempic-labelled pens being imported into Australia”. These were labelled with batch number NPSG234.

The products detected by ABF were purchased online from an overseas website and imported under the personal importation scheme.

“They were not bought from an Australian pharmacy,” TGA said.

Both of those batch numbers have been confirmed as not genuine batch numbers by Novo Nordisk, the manufacturer of Ozempic.

And all the fake products so far detected by TGA also share details that can distinguish them from genuine Ozempic.

How to spot a fake

Other than the batch numbers, the TGA said “there are clear inconsistencies from the original product to look out for”.

“Consumers should be warned that manufacturers of counterfeit goods are producing products that, to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources,” it said.

Spelling errors, instruction leaflets which are not printed in English, unsealed packaging, and differences in medicine size, shape, and appearance are all potential signs of a counterfeit product.

Other inconsistencies with genuine Ozempic pens were found on the end caps of the counterfeit pens, which were blue instead of grey, the dosage barrel which was in a different place, and “the rendering of the packaging” which was found to be poor quality.

“These are indicators that the medicine has not been produced by the original manufacturer or is being illegally sold in the wrong market,” TGA said.

Safe alternatives amid supply shortage

Genuine Ozempic will remain in limited supply for the rest of 2024, Novo Nordisk told the TGA in July, following a surge in demand months earlier.

“This additional demand is caused mainly by a rapid increase in prescribing for ‘off-label’ use (such as weight loss),” TGA said.

The Medicine Shortage Action Group (MSAG) has since urged prescribers to avoid prescribing Ozempic to patients where there are suitable alternatives.

It also recommended that patients who are using Ozempic off-label instead use Wegovy, a new brand of semaglutide specifically indicated for chronic weight management.

“Supplies should be conserved for patients who are stabilised on Ozempic who have no other treatment options,” TGA said.

Following the discovery of the counterfeit products, the TGA said: “We are also working to provide consumers with safe alternatives, such as approving the importation of legitimate overseas-registered semaglutide products for temporary supply.”

“Details about these overseas-registered products are available on the section 19A approvals database on the TGA website.”

Anyone experiencing symptoms of severe low blood sugar levels (hypoglycaemia) after using a product labelled as Ozempic is urged to call triple-0.