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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - February 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2024 (PDF).

This issue notifies clinicians that codeine linctus has now been reclassified as a prescription-only medicine (POM), following a public consultation. A recent review identified greater levels of recreational use than the intended use as a cough suppressant. As a risk minimisation measure to protect the health of patients this product will no longer be supplied without a prescription.

This issue also advises clinicians that pseudoephedrine has been very rarely associated with posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These conditions present with a sudden severe headache or thunderclap headache, sudden onset of nausea and vomiting, confusion, seizures and/or visual disturbances. Urgent medical attention should be sought if these symptoms occur and patients presenting with these symptoms should be asked about their medication history.

Lastly in this issue is a summary of letters to healthcare professionals in January. These generally related to supply issues and recalls but also include letters sent to appropriate healthcare professionals about revised educational materials for valproate-containing medicines, the dose-dependent increased risk of atrial fibrillation in patients using omega-3-acid ethyl ester medicines as reported in the drug safety update last month and a change to the pump priming advice prior to first use of Tostran® (Testosterone, 2% gel) following a manufacturing change.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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Drug Safety Update - January 2024

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.

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SMC Update - January 2024

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.

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Drug Safety Update - December 2023

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.

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SMC Update - December 2023

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Osilodrostat (Isturisa®) has been rejected for use in the treatment of endogenous Cushing’s syndrome in adults. The manufacturer failed to make a submission for this indication. In considering the product license, 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.

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