TGA urges ‘extreme caution’ amid fake Ozempic pen imports

The Therapeutic Goods Administration (TGA) has called on GPs to warn their patients of the dangers of using counterfeit Ozempic-labelled pens currently being imported into Australia, as people scramble to access the in-demand medication.
 
The TGA issued the warning this week after several pens were detected, leading one patient to suffer life-threatening complications after using a fake Ozempic pen purchased overseas and imported into Australia.
 
In collaboration with Australian Border Force (ABF), the TGA is now laboratory testing the pens, but warned that the safety, quality, and efficacy of these products remains unknown.
 
It says the counterfeit products have several inconsistencies compared to legitimate Ozempic pens, including spelling errors, instruction leaflets not in English, unsealed packaging, and changes in medicine size, shape, or appearance.
 
‘The two products subject to this alert both appear to be relabelled insulin pens,’ the TGA said.
 
‘The end cap is blue, not grey, the dosage barrel is in a different place, the sticker is not adhering properly to the pen and the rendering of the packaging is poor quality.’
 
The batch numbers labelled on the pens, NPSG234 detected by ABF and JS7A925 from the adverse event, have been confirmed as not genuine batch numbers by Ozempic manufacturer Novo Nordisk.
 
A Novo Nordisk spokesperson said the counterfeit medications are a ‘significant issue within the pharmaceutical industry’, particularly for high-demand medications like Ozempic.
 
‘The importation of counterfeit Ozempic pens into Australia is a significant concern as counterfeit medications pose a serious risk to patient safety,’ they told newsGP.
 
‘Ensuring that medications are sourced from reputable and authorised suppliers is crucial in mitigating the risk of counterfeit products.’
 
The TGA has confirmed that the products detected by ABF were purchased online from an overseas website and imported under the personal importation scheme, saying they were not bought from an Australian pharmacy.
 
‘For your safety, always buy medicines from reputable sources and consult your healthcare provider or local registered pharmacy if you have any concerns,’ the TGA said.
 
‘We strongly advise extreme caution when buying medicines from unknown overseas websites and recommend obtaining them from an Australian pharmacy.’
 
Chair of RACGP Specific Interests Obesity Management, GP and dietitian Dr Terri-Lynne South told newsGP the counterfeit pens mean patients have no idea what they are really putting into their body.
 
‘My other concern is that even if it was legitimate semaglutide, how can you guarantee that it is active?’ she said
 
‘These medications are sensitive to heat and light and if you’re getting something that is sent through the mail where there may not be appropriate quality control of temperature, they might have the real product but it’s ineffective or altered, and that may cause harm.
 
‘There’s also concerns that if someone has used a medication that might be off label, they may not be willing to go to the doctor or put in a report to the TGA as well, so we don’t know how significant or prevalent this problem really is.’
 
The TGA’s warning came in the same week as a ban on pharmacies compounding glucagon-like peptide-1 receptor agonists (GLP-1 RAs) comes into effect.
 
As of 1 October, the pharmacies can no longer produce replicas of Ozempic and Mounjaro, as demand for the viral medicines continues to grow.
 
Last year, the TGA issued firm advice to GPs to not initiate new patients on Ozempic due to its short supply, and, according to Novo Nordisk, there will be limited availability in Australia until December.
 
It says the reason for this is ‘continued, unprecedented strong demand’ both in Australia and across the world, and that the company is continuing to expand its global manufacturing capacity.
 
In August, the semaglutide drug Wegovy, which is specifically targeted for weight loss, became available in Australia.
 
One month later, tirzepatide (sold as Mounjaro) also became available for GPs to prescribe as a treatment for overweight and obesity.
 
Dr South said the popularity of these medications for weight loss is showing no sign of slowing up, even with new products entering the Australian market.
 
She said, for GPs, the fake Ozempic pens are a reminder to warn their patients of the risks and dangers involved in seeking out such products without the advice of a healthcare professional.
 
‘The more conversations we have about obesity management and that it is a chronic, complex condition, the better,’ she said.
 
‘Even though there are some concerns about patients accessing off label and potentially counterfeit medication, I’m hoping that, as healthcare professionals and more broadly, we can be having positive conversations about weight control.
 
‘These medications are not a magic bullet.’
 
The TGA says it is continuing to check batch numbers of any products that may be subject to counterfeiting, as well as working with ABF to help stop future shipments and seizing and destroying intercepted products.
 
It is also calling on anyone worried about counterfeit medicines to report the matter, and to not dispose of it as it may be needed for testing.
 
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Mounjaro Ozempic semaglutide TGA Therapeutic Goods Administration tirzepatide Wegovy