The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2013 (PDF).
This issue contains drug safety advice informing clinicians that dabigatran (Pradaxa®) is now contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment related to their valve surgery due to an increased risk of thrombosis and bleeding events.
This section also notes that aqueous cream may cause local skin reactions, such as stinging, burning, itching, and redness. This seems to be linked with use as a leave on emollient, particularly in children, when the product contains sodium lauryl sulphate. In cases where irritation occurs it is recommended to use an alternative emollient that is free from sodium lauryl sulphate.
Finally, this section notes that there have been reported cases of toxin spread with botulinum toxin type B (Neurobloc®) that have mostly occurred with off-label use. It is recommended that usage should adhere to the licensed indication and that all patients are warned of the signs and symptoms of toxin spread.
This issue also contains information about a new learning module on benzodiazepines. The module covers adverse events, factors that raise the risk of adverse events and how the risk can be reduced.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.