Medicines regulator receives 46 reports of hospitalisations linked to weight-loss drugs

As of 16 August 2024, the MHRA had received 5,073 reports of common gastrointestinal reactions related to GLP-1 RA use, of which 46 reported hospitalisation of the individual.
Woman injects weight loss pen into her abdomen

The Medicines and Healthcare products Regulatory Agency (MHRA) has said it received 46 reports of hospitalisations associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs).

In a drug safety update published on 24 October 2024, the MHRA advised healthcare professionals to “inform patients upon initial prescription [of GLP-1 RAs], and when increasing the dose, about the common risk of gastrointestinal side effects, which may affect more than one in ten patients”.

“Healthcare professionals should also be alert for signs of misuse of these medicines in their patients, warn these patients that they are at risk of side effects and report any adverse reactions via the Yellow Card scheme,” it added.  

As of 16 August 2024, the MHRA said it had received 5,073 reports of common gastrointestinal reactions (including nausea, vomiting and diarrhoea) associated with GLP-1 RA use, of which there were 46 reported hospitalisations.

GLP-1 RAs, which include semaglutide and liraglutide, manage blood glucose levels in type 2 diabetes mellitus and are also licensed for weight loss.

The update also warned that patients who obtain a private prescription for GLP-1 RAs should “ensure this is dispensed from an authorised source, such as a registered pharmacy, to avoid the risk of receiving a falsified pen”.

In October 2023, the MHRA said that since January 2023, it had seized 369 potentially fake Ozempic (semaglutide; Novo Nordisk) pens and received reports of a “very small number” of people who were hospitalised after using potentially fake weight-loss pens.

The reported side effects of those hospitalised included hypoglycaemic shock and coma, which suggested that the fake pens may have contained insulin rather than semaglutide, the MHRA said.

Following concerns raised in June 2024 by Vicky Price, president-elect of the Society for Acute Medicine, around inappropriate supplies, pharmacists have called for stronger regulations around the prescribing of semaglutide.

Helen O’Neil, senior medicines optimisation pharmacist at Tees Valley, North of England Commissioning Support Unit, said: “It is important for healthcare professionals to ensure that patients prescribed these medications meet the eligibility criteria and are made aware of the potential side effects, as well as how to minimise these and what action they need to take if they do get side effects.

“Healthcare professionals should continue to report adverse effects in line with the Yellow Card reporting scheme where appropriate.”

“It is also important for patients to ensure that they obtain the medications from a reputable supplier, such as a registered pharmacy, to avoid the risk of receiving fake medications, of which the content is unknown,” O’Neill added.

Clare Davies, diabetes and endocrinology specialist pharmacist at Gateshead Health NHS Foundation Trust, said: “It is concerning to see such a high number of reports related to GLP-1RA use particularly including hospitalisations. However, all medicines carry risks of side effects. It is vitally important patients are aware of these potential side effects, counselled on these and know to report these promptly.

“Given the increase in use of GLP-1RA agents it is not unsurprising to have seen an increase in reports and use in real world settings of medicines does not replicate trial environments.”

“The positive impact of this drug safety update from the MHRA is that this shows that healthcare professionals are aware of these risks and continue to report via the Yellow Card scheme which should be commended and encouraged,” Davies added.

Alison Cave, chief safety officer at the MHRA, said: “All medicines carry a risk of potential side effects and GLP-1 RAs are no exception.

“The balance of benefits and risks outside the licensed indication has not been shown to be favourable. Please report cases of misuse especially if harm occurs.”

Last updated
Citation
The Pharmaceutical Journal, PJ, October 2024, Vol 313, No 7990;313(7990)::DOI:10.1211/PJ.2024.1.335779

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