- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Drug Safety Update - November 2014

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2014 (PDF).

The drug safety section in this issue reminds clinicians that agomelatine (Valdoxan®) may cause liver toxicity in some people and that liver function should be tested before and during treatment. It is recommended that treatment is stopped if serum transaminases exceed three times the upper limit of normal and that patients are advised to stop taking agomelatine and to get medical help immediately if they have any signs or symptoms of liver injury. This section also reports that there have been reports of Colobreathe® (colistimethate sodium) capsules shattering when pierced by their inhaler device. The instructions for inhaler use have been revised and it is recommended that the new inhaler is demonstrated to patients and carers and that the first dose is supervised.

The stop press section reminds readers of the risk of ingestion of desiccants in blister packs. There have been two reports recently of people swallowing the desiccant that came with their nicorandil tablets instead of the tablet itself. It is noted that the foil blister and patient information leaflet clearly advise people not to swallow the desiccant. It is recommended that people receiving blister packs containing a desiccant are reminded the desiccant should not be swallowed.

The other information section advises that the arrangements for email alerts about Drug Safety Update are changing. Current subscribers can check their settings at https://service.govdelivery.com/accounts/UKMHRA/subscriber/new.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.