Austria’s health authorities said they had reports that Ozempic counterfeit medicine had reached patients. UK regulators also said a small number of patients were hospitalised.
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Hypoglycemia and seizure were reported as serious side effects of using the falsified Ozempic pens which may have contained insulin instead of the active ingredient semaglutide, according to Austria’s Federal Office for Safety in Health Care (BASG).
“Due to the untested quality of the counterfeit drug, possible impurities and unknown ingredients, these counterfeits can also be life-threatening,” the Austrian agency said.
UK regulators also warned they had “received reports of a very small number of people who have been hospitalised after using potentially fake weight-loss pens”.
They confirmed that the patients were in the UK and that there were active investigations into the counterfeit drugs.
The serious side effects for those hospitalised included hypoglycaemic shock and coma.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) said it had seized “369 potentially fake Ozempic pens since January 2023,” and that there had been reports of counterfeit Saxenda pens obtained by members of the public.
Pens likely still in circulation
In Austria, the counterfeit pens likely came from a “source other than a pharmacy,” the country’s regulators warned.
The BASG said there may still be counterfeit pens in circulation, urging physicians to check whether the pens could be counterfeit and verify the source of supply if not from legal pharmacies.
Ozempic, sold by Danish pharmaceutical company Novo Nordisk, has become a blockbuster drug after being associated with weight loss.
It is currently authorised in the EU for the treatment of Type 2 diabetes, but it has been increasingly used as a weight loss medication for which it is not approved. It is a once-weekly injection.
Its main ingredient is semaglutide, which is also used in the drug Wegovy, which can be used to treat obesity.
Saxenda, meanwhile, uses a less effective active ingredient liraglutide, and is a daily injection. It is authorised in the UK and EU for weight loss.
Using Ozempic “off-label” for weight loss has led to limited availability of the medication for diabetic patients.
EU regulators had warned earlier in the month that falsified pre-filled Ozempic pens had been identified in Austria and Germany. Health authorities had said they had also been identified at two wholesalers in the UK.
Packaging differences
Ozempic pens have 2D barcodes and unique serial numbers on each package. While the counterfeit packs also had serial numbers, when they were scanned, those codes were inactive.
Austrian authorities added that there were several distinguishing features between the original pre-filled pens and the falsified ones, including a different blue colour on the pens. The safety window in the counterfeit is transparent while it is grey in the original as well.
The dose adjustment ring and labelling on the needles were also different for the counterfeit pens.
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The BASG warned that there may be counterfeits that “look different or are not offered as a pre-filled pen”.
MHRA warned patients not to buy prescription-only medicines online.
“We at Obesity UK are very concerned to hear reports that people living with obesity are falling victim to criminals who are obtaining and selling fake weight loss medication,” said Professor Paul Gately, CEO of Obesity UK, in a statement.
“The dangers to health are clear. Our advice, like that of the MHRA, is that only medication prescribed by a qualified medical/healthcare professional should be taken”.
