European regulators investigate pancreatic risks of incretins
European medicines regulators have launched an investigation into the potential link between incretins and pancreatic disease in patients with type 2 diabetes.
The investigation came after studies found an increased risk of hospitalisation due to acute pancreatitis and signs of pancreatitis and pre-cancerous pancreatic cellular changes in tissue samples from people with type 2 diabetes who had been treated with gliptins and other glucagon-like peptide (GLP)-1 based therapies.
The pathological changes were seen in pancreatic samples obtained from organ donors who had died from a cause other than their diabetes.
The Agency’s Committee for Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment Committee are now looking closely at information provided by the researchers to decide whether regulatory action is needed.
The regulator says potential pancreatic effects have been a concern since the drugs were initially evaluated for marketing authorisation and that ‘rare cases of pancreatitis have been reported’.
Despite these doubts, GLP-1 based therapies have been widely adopted since NICE first gave approval for their use.
The EMA stressed there is currently no change to the recommendations for the use of GLP-1 based therapies, adding that GPs and other healthcare professionals should continue to prescribe them in accordance with the product information.
Dr Colin Kenny, a GP in Dromore, County Down, and a member of the Primary Care Diabetes Society steering committee, said that the drugs have become widely used third-line options because they are effective and generally well tolerated.
He said that if GPs are concerned about prescribing them they should make sure to take note of any previous history of pancreatitis or gall stones.
Dr Kenny added: ‘It’s important this work is done and the drugs are reassessed but GPs won’t be rushing to change because they haven’t got either effective or really safe alternatives.
Dr Alan Begg, a GP in Montrose, Scotland, who is on the SIGN guidelines development steering group, noted that the UK regulator MHRA [Medicines and Healthcare products Regulatory Agency] previously issued guidance on the potential risk of pancreatitis with GLP-1 based therapies.
He told Pulse: ‘Our protocol in the practice encourages us to inform patients taking [these drugs] about the characteristic symptoms of acute pancreatitis and what to do if they experience symptoms.’
He added: ‘The EMA action is based on post mortem tissue samples and raises the question of precancerous metaplasia. This illustrates the importance of post marketing surveillance, but we don’t have evidence as yet and apart from increased awareness we don’t need to change our practice.’