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Reminder of risks associated with amiodarone

MHRA publishes March safety update

March 22nd 2022

Tagged: MHRA alert

By MHRA

MHRA has published the March 2022 edition of Drug Safety Update.

New advice in this issue covers the following:

Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervision

Patients should be supervised and reviewed regularly during treatment as amiodarone is associated with serious and potentially life-threatening side effects.

Metformin in pregnancy: study shows no safety concerns

The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase as an addition or an alternative to insulin, if clinically needed. This is consistent with clinical practice and current patient advice. Healthcare professionals should advise patients with diabetes mellitus who are pregnant, think they may be pregnant, or are planning to have a baby to speak to their doctor. This is in case any changes are needed to their treatment or monitoring of their blood glucose. Patents with type 1 diabetes mellitus must continue to take their insulin (as directed by a healthcare professional) in pregnancy.

Cladribine (Mavenclad): new advice to minimise risk of serious liver injury

New liver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury.

COVID-19 vaccines and medicines: updates for March 2022

Letters and medicine recalls sent to healthcare professionals in February 2022