Drug Safety Update - October 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2024 (PDF).
This issue reminds clinicians of the potential side effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) including gastrointestinal side effects and hypoglycaemia that can occur in non-diabetic patients when used for weight management. Patients are also warned of the risks posed by falsified medicines when obtaining a private prescription and are advised to use registered pharmacies when getting the prescription dispensed.
Also in this issue, the MHRA are asking healthcare professionals to support new guidance for users of diabetes management equipment. It is recognised that insulin pumps and continuous glucose monitoring (CGM) devices are complex devices with the potential to result in serious harm in the event of error. Guidance has been published that explains to users how they can report safety concerns to the MHRA using the Yellow Card scheme. It is hoped that user reporting will improve the quality of information the MHRA receives and healthcare professionals are asked to highlight the guidance to appropriate patients and their families, carers and representatives.
This issue also advises clinicians of the need to monitor blood pressure when prescribing bromocriptine for prevention or inhibition of post-partum physiological lactation. It is noted that bromocriptine should only be prescribed to suppress post-partum physiological lactation, where it is medically indicated such as intrapartum loss, neonatal death, or in some cases of HIV infection of the mother. Non-pharmacological interventions are recommended for routine lactation suppression and for relieving symptoms of postpartum breast pain and engorgement. Where bromocriptine is still medically indicated, it remains contraindicated in uncontrolled hypertension, hypertensive disorders of pregnancy, hypertension post-partum, a history of coronary artery disease or other severe cardiovascular conditions. During treatment, blood pressure should be monitored, especially early in treatment and after dose increases. Treatment should be discontinued immediately if the patient develops any signs or symptoms of hypertension.
Lastly, this issue contains a summary of letters to healthcare professionals in September. These generally related to supply issues and recalls but included a letter regarding the potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the 3 months prior to conception.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
