The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2024 (PDF).
This issue notifies clinicians of the new safety and educational materials to support regulatory measures to reduce the harms from valproate in men and women under 55 years of age. This includes a patient information leaflet, a patient guide and an information page that collects all resources in one place.
This issue also advises clinicians that systemic fluoroquinolone antibiotics must now only be prescribed when other commonly recommended antibiotics are inappropriate. The MHRA has recently reviewed the existing measures in place to encourage safe prescribing and has now taken additional regulatory actions to update prescribing information for all systemic fluoroquinolones.
Also this month, clinicians are notified that systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients using omega-3-acid ethyl ester medicines. These studies recruited patients with established cardiovascular diseases or cardiovascular risk factors but in this population the incidence of atrial fibrillation was 3.9% when active treatment was compared to placebo. It is recommended that patients are advised to seek medical attention if they develop symptoms of atrial fibrillation and if atrial fibrillation is confirmed the medicine should be discontinued permanently.
Lastly in this issue is a summary of letters to healthcare professionals in December. These generally related to supply issues and recalls.
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.
Setmelanotide (Imcivree®) has been rejected for use in the treatment of obesity and the control of hunger associated with genetically confirmed Bardet‑Biedl syndrome (BBS) in adults and children 6 years of age and above. The manufacturer failed to make a submission for this indication. In considering the product license and acquisition cost, it would be expected that this medicine would be prescribed and monitored by a specialist.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of December 2023. This month there are three guidelines, two technology evaluations and two technology appraisals that impact upon primary care.
The Acne vulgaris: management guideline has been updated. It covers management of acne vulgaris in primary and specialist care. The update clarifies recommendations on oral isotretinoin treatment in line with the 2023 MHRA advice on the introduction of new safety measures.
The Digitally enabled therapies for adults with depression health technology assessment has been updated. Three digitally enabled therapies can be used as treatment options for adults with depression while further evidence is generated on their clinical and cost effectiveness. This update provide further information in the evidence generation plan.
The Digitally enabled therapies for adults with anxiety disorders health technology assessment has been updated. Six digitally enabled therapies can be used as treatment options for adults with anxiety disorders while further evidence is generated on their clinical and cost effectiveness. This update provide further information in the evidence generation plan.
The Cardiovascular disease: risk assessment and reduction, including lipid modification guideline has been published. It covers identifying and assessing risk of cardiovascular disease (CVD) in adults without established CVD and lifestyle changes and lipid-lowering treatment for primary and secondary prevention of CVD. It replaces previous guidance and contains a new recommendation on the target lipid level for secondary prevention of CVD.
The Empagliflozin for treating chronic kidney disease technology appraisal has been published. This treatment is recommended as an option for treating chronic kidney disease (CKD) in adults, only if:
- it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and
- people have an estimated glomerular filtration rate of:
- 20 ml/min/1.73 m2 to less than 45 ml/min/1.73 m2 or
- 45 ml/min/1.73 m2 to 90 ml/min/1.73 m2 and either:
- a urine albumin-to-creatinine ratio of 22.6 mg/mmol or more, or
- type 2 diabetes.
The Targeted-release budesonide for treating primary IgA nephropathy technology appraisal has been published. This treatment is recommended as an option for treating primary immunoglobulin A nephropathy. This recommendation is contingent on a commercial agreement and as such it is expected prescribing would remain with a specialist.
The Bipolar disorder: assessment and management guideline has been updated. It covers recognising, assessing and treating bipolar disorder (formerly known as manic depression) in children, young people and adults. This update amends recommendations in line with the latest MHRA guidance on the use of valproate.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Chief Medical Officer has written to healthcare professionals via the Central Alerting System (PDF) to advise that antiviral medicines may now be prescribed at NHS expense due to rising levels in reporting of influenza-like illness.
UKHSA surveillance data indicates that influenza is circulating in the community and as such GPs and other prescribers working in primary care may now prescribe antiviral medicines for the prophylaxis and treatment of influenza. NICE has issued guidance on the treatment and prevention of influenza with antiviral medication and the UKHSA has also published guidance on how to manage influenza using anti-viral agents.
Clinicians should remember to endorse the prescription with 'SLS' to ensure that it can be dispensed in community pharmacies without undue delay.
Action: Clinicians should be aware of this letter and familiarise themselves with the current prescribing guidance.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2023 (PDF).
This issue reminds clinicians of the risk of pathological gambling and other impulse control disorders associated with aripiprazole use. This reminder has been issued due to a rise in Yellow Card reports. Clinicians should ensure patients and their caregivers are aware to be alert to the development of new or increased urges to gamble and other impulse control symptoms, such as excessive eating or spending, or an abnormally high sex drive. In such cases, dose reductions or medication cessation may be required.
This issue also warns clinicians to be aware of the risk of cobalt sensitivity reactions seen in association with vitamin B12 (hydroxocobalamin and cyanocobalamin) treatments. The case reports have typically described skin reactions occurring within 72 hours of starting treatment. When such reactions arise, the risks and benefits of continued treatment should be reassessed. Treatment can be continued with appropriate advice and management of the reaction symptoms. Individuals with a known cobalt allergy should speak to a healthcare professional before starting B12 treatments.
Lastly in this issue is a summary of letters to healthcare professionals in November. These generally related to supply issues and recalls but also a reminder that as from January 2024 valproate containing medicines must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or unless there are compelling reasons that the reproductive risks do not apply.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
