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.