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Drug Safety Update - April 2020

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

This month clinicians are provided with a summary of the key advice and guidance issued so far on medicines safety and pharmacovigilance during the Coronavirus (COVID-19) pandemic. This includes a reminder to make use of the Yellow Card system to notify all suspected side effects. Advice on medicines use issued during COVID-19 includes:

Ibuprofen and NSAIDs
There is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and susceptibility to contracting COVID-19 or the worsening of its symptoms.

Antihypertensives
The is no evidence from clinical or epidemiological studies to support the concern that treatment with angiotensin-converting-enzyme inhibitors (ACE inhibitors or ACE-i) or angiotensin-receptor blockers (ARBs) might worsen COVID-19 infection

Chloroquine and hydroxychloroquine.
It is advised that trials are underway, and until there is clear, definitive evidence that these treatments are safe and effective these agents should only be used for this purpose within a clinical trial.

Interestingly, the Journal of the American Medical Association has recently published research advising against using high-dose chloroquine due to "safety concerns regarding QTc interval prolongation and increased lethality".

The summary of letters to healthcare professionals includes information about a recall of Emerade auto-injectors as some pens to fail to activate and deliver adrenaline and a recall of Esmya 5mg tablets following a new case of liver failure requiring liver transplant in a patient taking the medicine.

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