The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Drug Safety Update article for July 2025.
This update warns clinicians about a small increase in the risk of Guillain-Barré syndrome following vaccination with respiratory syncytial virus (RSV) vaccine (Abrysvo® or Arexvy®) in adults aged 60 years and older. There have been 21 case reports submitted to the MHRA on a background of almost 2 million delivered doses. There is currently no evidence of increased risk in pregnant women. Abrysvo is the vaccine in use in the NHS but data from the United States indicates this issue may also affect Arexvy.
Older patients in the NHS Immunisation cohort (aged 75-79years old) should be warned to seek urgent medication attention should they develop neurological symptoms. This would include tingling, numbness or pins and needles usually followed by muscle weakness and difficultly moving joints.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Fezolinetant (Veoza®) has been rejected for use in the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Abaloparatide (Eladynos®) has been accepted for restricted use in the treatment of osteoporosis in postmenopausal women at increased risk of fracture. The restriction limits use to patients at very high risk of fracture, assessed using a validated fracture risk assessment tool. This advice also applies only in the context of approved NHSScotland Patient Access Scheme and as such it would be expected that this item would be prescribed in secondary care.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published two Drug Safety Update articles for June 2025.
Earlier this month updated safety and educational materials were made available to support the implementation of the regulatory measures for valproate containing medicines announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. These materials also include previous updates to product information on the risk of low birth weight in children exposed to valproate during pregnancy.
More recently, a temporary restriction on the use of the IXCHIQ® Chikungunya vaccine in people aged 65 years and over has been announced. This is a precautionary measure while the MHRA conducts a safety review following very rare fatal reactions reported globally.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Bempedoic acid (Nilemdo®) has been rejected for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
- alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.
The manufacturer failed to make a submission for this indication. It should be noted that the SMC have already accepted this treatment for primary hypercholesterolaemia or mixed dyslipidaemia and NICE Guidance has been published for this medication.
Bempedoic acid / ezetimibe (Nustendi®) has been rejected for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,
- in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or,
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.
The manufacturer failed to make a submission for this indication. It should be noted that the SMC have already accepted this treatment for primary hypercholesterolaemia or mixed dyslipidaemia and NICE Guidance has been published for this medication.
Sumatriptan 85mg / naproxen 457mg (Suvexx®) has been rejected for use in the acute treatment of the headache phase of migraine attacks with or without aura in adults where treatment with a mono-entity product has been insufficient. It is noted this product is available at a considerable cost premium to sumatriptan 100mg and naproxen 500mg tablets taken separately.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Drug Safety Update for May 2025.
This update warns clinicians of an increased risk of intrahepatic cholestasis of pregnancy (ICP) associated with thiopurines (azathioprine, mercaptopurine and tioguanine). ICP has rarely been reported in association with azathioprine therapy but the risk is believed to apply to other thiopurines. ICP may occur earlier in pregnancy when thiopurines are in use. Stopping or reducing the dose of the thiopurine drug may improve liver function tests but a case-by-case assessment is required to determine the appropriate course of action. Patients should be advised to report symptoms of ICP which include intense itching without a rash, nausea, and loss of appetite.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
