Drug Safety Update - May 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2023 (PDF).
This issue reminds clinicians of the need for renal function checks and appropriate dose adjustment when issuing direct-acting oral anticoagulants (DOACs). This section also advises on the availability of risk minimisation materials to support the safe use of new paediatric formulations of rivaroxaban (Xarelto®) and dabigatran (Pradaxa®).
This issue also provides updated advice regarding the use of febuxostat in patients with pre-existing major cardiovascular diseases. It was advised in 2019 to avoid use in this scenario but it is now advised that febuxostat therapy can be used cautiously in such patients. The 2019 advices was based on the results of the CARES Study but the recently published FAST Study showed that febuxostat was non-inferior to allopurinol therapy with respect to cardiovascular events. The dose should be titrated accordingly and it is noted that allopurinol remains the first-line treatment.
Lastly in this issue is a summary of letters to healthcare professionals in April. These generally related to supply issues and recalls. Of particular note, Emerade® has been recalled in both 500micrograms and 300micrograms due to some device failures seen in testing after the device had been dropped.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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