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

Drug Safety Update - October 2012

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2012 (PDF).

This update contains drug safety information advising clinicians that there a risk of dose-related hepatotoxicity and liver failure with agomelatine. It is already recommended that liver tests are performed before starting treatment and frequently after initiation. This recommendation has now been extended to include testing periodically after a dose increase. Treatment should be stopped if there are symptoms or signs of potential liver injury or if serum transaminases levels exceed three times the upper limit of normal.

The hot topic section contains a summary of the evidence that supports the recent advice to restrict the daily dose of simvastatin when used in conjunction with amlodipine or diltiazem. It also contains a review of the impact of sales restrictions placed on pseudoephedrine and ephedrine in 2008 with the aim of reducing use of these agents in the illicit manufacture of the Class A controlled drug methylamphetamine.

Finally, the stop press section contains information from a recent safety review that provides further evidence that diclofenac carries a higher cardiovascular risk than other non-selective NSAIDs and similar to selective COX-2 inhibitors.

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