The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has urged healthcare professionals to ensure patients and the public are aware of the dangers of falsified Ozempic (semaglutide) and Saxenda (liraglutide) products. The call came in an alert published online on 23 November.
The reminder and call for vigilance, supporting previous warnings, was prompted by the discovery of falsified products in the UK, including pens containing insulin. It is likely to become ever more relevant as the use of Ozempic and Saxenda extends into the general weight loss market and out of their primary clinical use in patients with type 2 diabetes or obesity.
Andy Morling, deputy director of criminal enforcement at the MHRA, updated Medscape News UK on the current scale of the problem. As of 16 November 2023, the MHRA had seized 869 falsified Ozempic pens. He explained that 500 counterfeit pens were identified before reaching the legal supply chain at two UK wholesalers. These pens were prevented from reaching the public at any point. The remaining 369 counterfeit pens were destined for sale through illegal means, indicating a concerning entry into a black market supply chain.
Morling said that counterfeit products are likely to appear on websites designed to look like legitimate pharmacies or online retailers, while others could be advertised less formally through online marketplaces or social media.
At present, the MHRA estimates that the illicit market in falsified products is fairly small in scale, but the dangers are significant. The insulin found by the MHRA in many of the fake Ozempic pens sold illegally online is sufficient to cause dangerously low blood sugar levels and possible loss of consciousness and seizures. They are asking GPs and other healthcare professionals to be aware of the possibility that hypoglycaemic symptoms may be due to use of a falsified product.
Up to 20 November 2023, the MHRA has received 16 reports of the purchase or use of products supposedly containing semaglutide or liraglutide that were suspected to be falsified. They say that, in five cases, the Saxenda and Ozempic pens were confirmed to contain insulin, with some users being hospitalised and requiring urgent care.
MHRA Chief Safety Officer, Alison Cave, emphasised in a press release that, “Fake Ozempic pens can contain anything. Those who buy them have no idea what they might be taking, and the syringes themselves may not be sterile.”
Morling emphasised, however, that, “There remains no risk to patients receiving Ozempic pens through legitimate means and their healthcare providers.”
An MHRA press release statement concluded: “We are advising all members of the public not to use any pre-filled weight loss pens they may have bought online and instead to report it to us so that we can investigate and take any necessary action. If you suspect that you’ve had a side effect to semaglutide, liraglutide, or any other medicine, or suspect it’s not a genuine product, you can report it to our Yellow Card scheme.”
Identifying the fake products may not be easy, as they can be designed to look very similar to the legitimate items. This emphasises the importance of checking the legitimacy of suppliers.
Given that the threat comes mainly from online sources, the MHRA says they are working closely with social media providers, search engine operators, and the broader internet industry to prevent and disrupt illegal sales and to identify those responsible.
“The MHRA takes regulatory action where necessary and appropriate to do so [but] we do not comment publicly on resourcing specifics,” Cave said in a statement provided to Medscape News UK. “We moved quickly to take action to address the emerging threat and we will continue to use all tools available to us to crack down on this harmful illegal trade.”
