The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2024 (PDF).
This issue reminds clinicians of the risk of psychiatric and sexual side effects seen in association with finasteride and notes that these effects can persist after discontinuation of treatment. It is recommended that patients are asked if they have a history of depression or suicidal ideation before commencing treatment and are advised to seek medical advice should symptoms develop during treatment. A patient card will be introduced in all finasteride packs, which will highlight the risk of sexual side effects and psychiatric side effects reported with finasteride to increase awareness among patients and prescribers.
This issue also reminds clinicians to be alert to the risk of neuropsychiatric reactions in all patients, including children and adolescents, who are prescribed montelukast. Warnings in the Patient Information Leaflet have been strengthened and highlighted for greater emphasis. It is recommended that patients and their caregivers are directed to read the list of neuropsychiatric reactions in the Patient Information Leaflet and to seek medical advice immediately should they occur. Treatment should be discontinued with the occurrence of new or worsening neuropsychiatric symptoms.
This issue also contains a summary of letters to healthcare professionals in March. 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 National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of April 2024. This month there are two guidelines that impact upon primary care.
The Twin and triplet pregnancy guideline has been updated. It covers care for pregnant women and pregnant people with a twin or triplet pregnancy in addition to routine care during pregnancy and labour. The update makes new recommendations including the use of progesterone 200 mg vaginal capsules to prevent preterm birth.
The Endometriosis: diagnosis and management guideline has been updated. It covers diagnosing and managing endometriosis. It aims to raise awareness of the symptoms of endometriosis, and to provide clear advice on what action to take when women and people with signs and symptoms first present in healthcare settings. This update provides new and updated recommendations on treatment of endometriosis when fertility is a priority.
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.
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.
During March 2024 Clinical Knowledge Summaries were published or updated in the following areas.
The Abortion topic is new. The remaining topics have all been reviewed and updated with minor structural and layout changes. The Breast cancer - managing FH topic now contains more details on risk factors. The Cirrhosis topic has been updated in line with current literature, a new section has been added detailing assessment of suspected cirrhosis, the criteria on when to consider palliative care referral have been expanded and the recommendations on primary care management of a person with cirrhosis have been updated and expanded.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
