The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2022 (PDF).
This issue advises clinicians that vitamin B12 deficiency is now considered to be a common side effect in patients on metformin treatment. The risk increases with higher dose or longer treatment duration and in those with existing risk factors. Checking vitamin B12 serum levels is recommended in patients being treated with metformin who have symptoms suggestive of vitamin B12 deficiency, this may include megaloblastic anaemia or new-onset neuropathy. It is also advised that periodic monitoring for patients with risk factors for vitamin B12 deficiency should be considered.
Clinicians are also notified that a National Patient Safety Alert has been issued following serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. It is recommended that patients should be moved onto alternative insulin pumps where possible.
This issue contains the latest COVID-19 vaccine and medicine information including an updated shelf life for Comirnaty® to 12 months and a warning on the risk of flare-ups of capillary leak syndrome in patients who already have this syndrome following Spikevax® use.
Lastly in this issue is a summary of letters to healthcare professionals in May. 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.