The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2023 (PDF).
This issue reminds clinicians of the need for renal function checks and appropriate dose adjustment when issuing direct-acting oral anticoagulants (DOACs). This section also advises on the availability of risk minimisation materials to support the safe use of new paediatric formulations of rivaroxaban (Xarelto®) and dabigatran (Pradaxa®).
This issue also provides updated advice regarding the use of febuxostat in patients with pre-existing major cardiovascular diseases. It was advised in 2019 to avoid use in this scenario but it is now advised that febuxostat therapy can be used cautiously in such patients. The 2019 advices was based on the results of the CARES Study but the recently published FAST Study showed that febuxostat was non-inferior to allopurinol therapy with respect to cardiovascular events. The dose should be titrated accordingly and it is noted that allopurinol remains the first-line treatment.
Lastly in this issue is a summary of letters to healthcare professionals in April. These generally related to supply issues and recalls. Of particular note, Emerade® has been recalled in both 500micrograms and 300micrograms due to some device failures seen in testing after the device had been dropped.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of May 2023. This month are three guidelines and two health technology evaluations that impact upon primary care.
The Cardiovascular disease: risk assessment and reduction, including lipid modification guideline has been updated. It covers the assessment and care of adults who are at risk of or who have cardiovascular disease. This update now recommends use of the QRISK3 prediction tool. The recommendations about cardioprotective diets and statin treatment for primary and secondary prevention have been reviewed. The threshold for considering treatment has remained at a 10‑year risk of CVD is 10% or more.
The Acne vulgaris: management guideline and been updated. It covers the management of acne vulgaris in primary and specialist care. The updated included recent safety updates including recommendations to strengthen the safety of isotretinoin treatment.
The Diabetes (type 1 and type 2) in children and young people: diagnosis and management guideline has been updated. It covers the diagnosis and management of type 1 and type 2 diabetes in children and young people aged under 18. The update made new recommendations on blood glucose monitoring and management.
The Digitally enabled therapies for adults with depression and the Digitally enabled therapies for adults with anxiety disorders early value assessments have been published. Three and six digitally enabled therapies are respectively recommended as treatment options. It is recommended that where these options are used, further evidence is generated on their clinical and cost effectiveness.
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.
Rimegepant (Vydura®) has been rejected for use as a preventive treatment of episodic migraine in adults who have at least four migraine attacks per month. The justification of the cost in relation to its health benefits was not sufficient and the submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Rimegepant (Vydura®) has been accepted for restricted use for the acute treatment of migraine with or without aura in adults. The restrictions limits use to patients who have had inadequate symptom relief after trials of at least two triptans or in whom triptans are contraindicated or not tolerated; and have inadequate pain relief with non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol.
Empagliflozin (Jardiance®) has been accepted for use in adults for the treatment of symptomatic chronic heart failure with preserved ejection fraction (left ventricular ejection fraction [LVEF] >40%).
Icosapent ethyl (Vazkepa®) has been rejected for use to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk. The submission reviewed potential use in patients with elevated triglycerides (≥1.7mmol/L) and established cardiovascular disease or diabetes plus at least one other risk factor. The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Chief Medical Officer has written to healthcare professionals via the Central Alerting System (PDF) to advise that antiviral medicine supply at NHS expense for influenza-like illness has now ended.
The alert notes that recent surveillance data from UK Health Security Agency (UKHSA) indicates that circulation of influenza in the community has returned to baseline levels. As such clinicians are advised to no longer prescribe antiviral medicines for the prophylaxis and treatment of influenza and community pharmacies are advised to not longer supply against such prescriptions.
Action: Clinicians should be aware of this letter and cease issuing antivirals for influenza at this time.
During April 2023 Clinical Knowledge Summaries were published or updated in the following areas.
All of the topics have been reviewed and updated with minor structural and layout changes. The Blackouts and syncope topic has been renamed from Blackouts and the recommendations have been updated in line with current evidence in the literature. The Alopecia areata topic has been updated to include offering specialist referral for any person wishing to have treatment for alopecia areata and specific treatment advice for when more than 50% of the scalp is involved has been removed as no basis could be found for this advice.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
