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Drug Safety Update - July 2013

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2013 (PDF).

This issue contains drug safety advice reminding clinicians that codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone. These new recommendations are due to an increased risk of morphine toxicity when susceptible children receive codeine for pain, particularly after surgery.

This section also advises that retigabine (Trobalt®) should now only be used as an adjunctive treatment for drug-resistant partial onset seizures in adults with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated. Treatment has been associated with pigment changes of ocular tissue including the retina. A comprehensive ophthalmic examination should be done at the start of treatment and at least every 6 months thereafter during treatment. When pigment changes are detected the benefits and risks of continued treatment should be reassessed.

This issue also contains information about the Pharmacovigilance Risk Assessment Committee which is a scientific committee at the European Medicines Agency that is responsible for the assessment and monitoring of the safety of medicines across Europe. The MHRA has already included recommendations made by PRAC in previous issues of the Drug Safety Update and will continue to do so.

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