Up to and including May 29, the Medicines and Healthcare products Regulatory Agency (MHRA) has received “a total of 111 UK spontaneous suspected adverse drug reaction (ADR) reports with a fatal outcome” where glucagon-like peptide-1 receptor agonists (GLP-1 RA) medicines were used for any reason, the regulator has revealed.
The drugs – which are also used to treat diabetes - have soared in popularity since Wegovy and Mounjaro were launched for weight loss in the UK in 2023.
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Responding to a freedom of information (FOI) request from C+D, the MHRA this month stressed that a report does “not necessarily mean that [a death] was caused by the medicine, only that the reporter has a suspicion it may have been”.
“Underlying or previously undiagnosed illness unrelated to the medicine can also be factors in such reports,” it added.
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It told C+D that the number of reports “does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different medicines”.
And it said that the number of adverse reaction reports can increase for various reasons, including increased use of the drugs as well as “promotion and publicity about a product”, while “reporting tends to be highest for newly introduced medicines”.
Drug linked to the most deaths?
The MHRA told C+D that from the point of licensing until the end of May, the GLP-1 RA linked to most deaths through ADR reports was liraglutide with some 37 reports with a fatal outcome.
The second most mentioned drug in the reports was tirzepatide – also known as Mounjaro – with 33 reports.
And some 30 deaths were linked to semaglutide – which is licensed for weight loss under the name Wegovy.
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The MHRA added that seven reports were linked to dulaglutide and five to lixisenatide.
“Please note one report can contain multiple suspect drugs and as a result the breakdown provided…is not equal to the total number of reports,” it stressed.
“Fatal” report breakdown
The MHRA told C+D that of the total 111 fatal ADR reports it had received in the period, 32 referred to deaths where GLP-1 RAs were indicated for “weight management alone” or the drug was “only licensed for weight management – Mounjaro, Saxenda, Wegovy”.
Some 40 reports related to drugs with an indication for “diabetes alone”, it said.
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Another nine reports referred to patients taking GLP-1 RAs for “both weight management and diabetes”, it added.
And 30 reported a fatal outcome “with an indication other than weight management or diabetes, or where no indication has been reported”, the MHRA said.
“All adverse reaction reports received by the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals,” it told C+D.
“If appropriate, regulatory action would be taken if any serious risks were confirmed,” it added.
Weight loss latest
In November, the medicines regulator revealed to C+D that it had received 10 UK spontaneous reports with GLP-1RAs indicated for weight management that reported a fatal outcome.
The new stats come as the chief pharmaceutical officer (CPhO) for England last week told C+D that there is a “really significant opportunity” for community pharmacy in new weight loss jab services at the NHS Confed Expo in Manchester.
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Also speaking on weight loss drugs in a separate session at the conference, NHS England (NHSE) national medical director Sir Stephen Powis stressed that “we are at the very early stages of learning how to use these drugs” and “there is more to learn”.
And England’s chief medical officer (CMO) Professor Chris Whitty similarly stressed that GLP-1 RAs are “not a get out of jail card”.
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Powis also briefly touched on the pricing of the drugs, saying that “we will get to the stage of generics” for them and “prices will drop” in the future.
The comments come after Community Pharmacy England (CPE) NHS services director Alastair Buxton last month revealed that a pharmacy weight loss service could be commissioned “in due course”.
It followed reports claiming that a multimillion-pound deal “with a major pharmaceutical firm” is set to fund a national NHS weight loss jab prescription pilot in pharmacies.
