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Drug Safety Update - February 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2016 (PDF).

This issue launches communication materials to further improve awareness of the risks of developmental disorders and congenital malformations associated with valproate use in pregnancy. These materials are aimed at supporting discussion of these risks with women of childbearing potential and girls who take valproate. Hard copies are being sent to relevant healthcare professionals from this week.

This issue also highlights the risk of potentially fatal hyperkalaemia during concurrent use of spironolactone and renin-angiotensin system drugs in heart failure. It is recommended that the combination is avoided where possible and especially in patents with renal impairment. Where treatment is necessary the lowest effective doses should be used and regular monitoring of blood electrolytes is essential in such patients.

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