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Drug Safety Update - March 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2020 (PDF).

This month clinicians are advised that the license for ulipristal acetate 5mg (Esmya®) has been suspended to protect public health while a safety review is conducted following a further case of liver injury requiring transplant. The product is being removed from the supply chain and it is recommended that patients are contacted and advised to stop treatment as soon as possible with a liver function test performed 2–4 weeks after stopping.

This issue also advises that SGLT2 inhibitor treatment should be interrupted during hospital admissions for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment may be restarted when the ketone values are normal and the patient's condition has stabilised.

This month there is also a reminder that benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. It is recommend that they are only prescribed together if there is no alternative and that patients are closely monitored for signs of respiratory depression.

The summary of letters to healthcare professionals this month includes information about Typhim Vi being supplied in an export pack to meet increased demand and a recall of Emerade 150 microgram adrenaline pens due to the potential for device failure. The medical device letters include advice that Cardinal Health Genius 2 and Genius 3 tympanic thermometers should now be calibrated every 25 weeks rather than annually to assure accuracy and reduce the risk of misdiagnosis or delay in treatment.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.