The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Liraglutide (Saxenda®) has been accepted for restricted use as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:
- ≥30kg/m2 (obese), or
- ≥27kg/m² to <30kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea
The restriction limits use to patients at high risk of type 2 diabetes or cardiovascular disease and notes that patients should be treated in a specialist weight management service.
Dapagliflozin (Forxiga®) has been accepted for restricted use in the treatment of chronic kidney disease. The restriction limits use to patients who meet all of the following criteria:
- estimated glomerular filtration rate of ≥25 to ≤75 mL/min/1.73m2 at treatment initiation
- receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker (unless these are not tolerated or contraindicated)
- urine albumin creatinine ratio of at least 23mg/mmol, or type 2 diabetes mellitus or both
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 April 2022 (PDF).
This issue advises that a recent study has indicated that pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Data from 2,700 pregnancies with pregabalin exposure in the first trimester was compared with exposure to no antiepileptic drugs or lamotrigine or duloxetine. Full details of the study have been published. Patients are advised to continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary.
This issue contains the latest COVID-19 vaccine and medicine information including reassuring real-world data for for Spikevax COVID-19 vaccine and Comirnaty COVID-19 vaccine when used during pregnancy and breastfeeding. This section also notifies readers of the approval of Valneva COVID-19 vaccine and Evusheld (tixagevimab/cilgavimab) for COVID-19 prevention.
Lastly in this issue is 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 Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2022 (PDF).
This issue reminds clinicians that amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. It is recommended that patients on long-term amiodarone treatment are supervised and reviewed regularly during treatment. This should include liver and thyroid function tests before treatment, at 6-monthly intervals during treatment, and thyroid function should be monitored for several months after stopping treatment.
This issue also reports that a large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase as an addition or an alternative to insulin, if clinically needed.
This issue contains the latest COVID-19 vaccine and medicine information including a reminder about the UK COVID-19 Antivirals Pregnancy Registry and updated summaries of Yellow Card reporting.
Lastly in this issue is a summary of letters to healthcare professionals in February. 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.
Hydrocortisone modified-release (Efmody®) has been rejected for use in the treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. The manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Betula verrucosa extract (Itulazax®) has been rejected for use in the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group. The manufacturer did not make a submission for this indication.
Solriamfetol (Sunosi®) has been rejected for use in adult patients with obstructive sleep apnoea (OSA) to improve wakefulness and reduce excessive daytime sleepiness when these symptoms have not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). The manufacturer 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 Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2022 (PDF).
This issue notes that a UK COVID-19 Antivirals Pregnancy Registry has been created. The safety of COVID-19 antivirals in pregnancy has not been established and information is therefore requested for any pregnancies which occur during use of an antiviral, including paternal use. Reports are welcomes from healthcare professionals, pregnant women and partners of pregnant women.
This issue also highlights an observed increased risk of cardiovascular events in patients with rheumatoid arthritis following co-administration of azithromycin with hydroxychloroquine. Based on this data, healthcare professionals are advised to carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. Clinicians are also reminded to be vigilant for psychiatric reactions associated with hydroxychloroquine or chloroquine, especially in the first month of treatment.
This issue contains the latest COVID-19 vaccine and medicine information including the recent approval of the Nuvaxovid® COVID-19 vaccine developed by Novavax. The update also advises that weekly summaries of Yellow Card reporting events associated with coronavirus vaccine continues to be published.
Lastly in this issue is a summary of letters to healthcare professionals in January. These generally related to supply issues and recalls as well as details of the consultation proposal to make estradiol 10 microgram vaginal tablets available from pharmacies.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
