Patients in Austria and the UK have been hospitalized after using counterfeit weight-loss pens, according to health authorities in both countries. Serious side effects, including hypoglycemia and seizures, were reported in individuals who unknowingly used falsified Ozempic pens that may have contained insulin instead of the active ingredient, semaglutide. The Austrian Federal Office for Safety in Health Care (BASG) has expressed concerns about the untested quality of these counterfeit drugs, emphasizing the potential life-threatening risks posed by possible impurities and unknown ingredients.
UK regulators have also reported cases of people being hospitalized after using potentially fake weight-loss pens. Investigations are actively underway in the UK regarding these counterfeit drugs, with the severe side effects observed in patients including hypoglycemic shock and coma.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) disclosed that they had seized 369 potentially fake Ozempic pens since January 2023. Furthermore, reports indicated counterfeit Saxenda pens obtained by the public.
The source of these counterfeit pens in Austria appears to be outside of pharmacies, as cautioned by the BASG. The agency has urged physicians to scrutinize the pens to determine their authenticity and verify their source of supply if not obtained from legitimate pharmacies.
Ozempic, a product of Danish pharmaceutical company Novo Nordisk, has gained immense popularity for its association with weight loss. Although it is currently authorized in the EU for the treatment of Type 2 diabetes, it is increasingly used as a weight loss medication for which it lacks approval. Ozempic is administered as a once-weekly injection and features semaglutide as its primary ingredient, which is also utilized in the drug Wegovy for obesity treatment.
In contrast, Saxenda employs the less effective active ingredient liraglutide and is administered as a daily injection. It is authorized for weight loss in both the UK and EU.
The off-label use of Ozempic for weight loss has resulted in limited availability of the medication for diabetic patients. Earlier this month, EU regulators issued a warning about falsified pre-filled Ozempic pens identified in Austria and Germany. Similar counterfeit pens were also discovered at two wholesalers in the UK.
To distinguish counterfeit Ozempic pens from authentic ones, it was revealed that the original pens have 2D barcodes and unique serial numbers on their packaging. Counterfeit pens also featured serial numbers, but these were found to be inactive upon scanning. Several noticeable differences were noted, including variations in the blue color of the pens, the transparency of the safety window in the counterfeits (compared to the original’s grey), and discrepancies in the dose adjustment ring and needle labeling.
The MHRA issued a warning to patients against purchasing prescription-only medicines online to avoid counterfeit drugs.
Professor Paul Gately, CEO of Obesity UK, expressed deep concern over reports of individuals with obesity falling victim to criminals who sell fake weight loss medication. He emphasized the clear health dangers posed by these counterfeit drugs and, in alignment with the MHRA’s advice, stressed the importance of only taking medication prescribed by qualified medical or healthcare professionals.