The Medicines and Healthcare products Regulatory Agency (MHRA) is
reminding healthcare professionals to ensure patients are aware
of the known side effects of glucagon-like peptide-1 (GLP-1)
receptor agonists.
These medicines are used to treat type 2 diabetes or obesity,
with the common risk of gastrointestinal side effects which may
affect more than 1 in 10 patients. While most side effects for
these medicines are mild, some may also be serious.
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.
GLP-1 receptor agonists approved for weight management, are
effective treatment options for patients with a Body Mass Index
(BMI) higher or equal to 30 kg/m2 or for patients whose BMI is
higher or equal to 27 kg/m2 and have a weight-related medical
condition, such as cardiovascular disease.
GLP-1 receptor agonists can only be prescribed by a registered
healthcare professional.
When appropriately used in line with the product licence, the
benefits of these medications outweigh the risks for patients.
However, this benefit-risk balance is positive only for those
patients within the approved indications for weight management or
type 2 diabetes as described in the product information.
If patients obtain a private prescription (from a non-NHS
prescriber), they should ensure this is dispensed from an
authorised source, such as a registered pharmacy, to avoid the
risk of receiving a falsified pen. They should be aware that some
falsified medicines have been found to contain insulin, which if
used, could cause severe hypoglycaemia (low blood sugar)
requiring urgent medical attention.
It is vital for patients to carefully read the instructions in
the Patient Information Leaflet and use the prescribed dose.
Potential side effects of these medicines can include
gastrointestinal conditions, such as vomiting and diarrhoea. In
most cases, these are not usually serious, but may sometimes lead
to more serious complications such as severe dehydration,
resulting in hospitalisation. Patients are advised to stay
hydrated by drinking plenty of fluids throughout treatment.
Gastrointestinal side effects are more likely to occur at the
start of treatment or after a recent increase in dose. Healthcare
professionals should also discuss the risk of serious, but less
common side effects such as pancreatitis and gall bladder
disorders.
Hypoglycaemia (low blood sugar) can occur in non-diabetic
patients using some GLP-1 receptor agonists for weight management
and healthcare professionals should ensure patients are aware of
the symptoms and signs of this condition, such as sweating,
shaking, feelings of tiredness or weakness and confusion. Where
this occurs, patients should eat or drink something that will
raise their blood sugar quickly, and if symptoms persist they
should seek medical attention.
Patients prescribed GLP-1 receptor agonists should speak to a
healthcare professional if they have any questions about
potential side effects.
Dr Alison Cave, MHRA Chief Safety Officer, said:
“All medicines carry a risk of potential side effects and
GLP-1RAs are no exception.
“We encourage healthcare professionals to ensure patients being
treated with these medicines are aware of the common side effects
and how to minimise risk.
“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”
, Secretary of State for Health and Social Care,
said:
“Weight-loss drugs have enormous potential. When taken alongside
healthy diet and exercise, they can be game changers in tackling
obesity and getting people back to good health.
“But these are not cosmetic drugs that should be taken to help
get a body beautiful picture for Instagram. These are serious
medicines and should only be used responsibly and under medical
supervision. They're not a quick fix to lose a few pounds and
buying them online without appropriate assessment can put
people's health at risk.
“Drugs approved for weight management should only be used by
those tackling obesity, where diet and exercise has been tried
first, and where patients are eligible.”
Healthcare professionals should consult our Drug Safety Update for
further advice.
ENDS
Notes to editors
- Further information is available in the Drug Safety Update.
- GLP-1 receptor agonists are used to treat type 2 diabetes and
obesity, with active ingredients including exenatide,
lixisenatide, liraglutide, dulaglutide, semaglutide and
tirzepatide. They work by mimicking the action of the natural
hormone GLP-1, which helps regulate blood sugar levels by
stimulating insulin secretion, reducing glucagon secretion,
slowing gastric emptying, and promoting satiety.
- Not all GLP-1 receptor agonists are approved for weight
management, products can include the active ingredients
semaglutide (Wegovy), tirzepatide (Mounjaro) and liraglutide
(Saxenda). GLP-1 receptor agonists can be used alone or in
combination with other diabetes medications. Some GLP-1 receptor
agonists have also been approved for weight management in obese
patients with a body mass index (BMI) greater than 30 kg/m² or
overweight patients with a BMI of 27 kg/m.
- Symptoms of hypoglycaemia (low blood sugar) can be found on
the NHS
website.
- Falsified medicines can cause a serious risk to health,
patients should only receive prescriptions from authorised
prescribers.
- A licensed indication refers to the approval to treat or
manage a specific medical condition.
