The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Daridorexant (Quviviq®) has been accepted for restricted use in the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning. The restriction limits use to people who have failed cognitive behavioural therapy for insomnia (CBT-I) or for whom CBT-I is unsuitable or unavailable. It is noted that the prescribing information recommends using this treatment for the shortest period possible.
Tirzepatide (Mounjaro®) has been accepted for restricted use in the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of diabetes
The restriction limits use to combination treatment with other oral anti-diabetic medicines as an option when glucagon-like peptide-1 (GLP-1) receptor agonists would be considered. Monotherapy treatment is not recommended as the company's submission related only to its use in addition to other medicinal products.
Glycopyrronium / formoterol fumarate (Bevespi Aerosphere®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Pitolisant (Wakix®) has been rejected for use to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP). The manufacturer failed to make a submission for this indication.
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 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.
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.
