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Drug Safety Update - April 2013

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

This issue contains drug safety advice informing clinicians of the potential risk of error with insulin degludec (Tresiba®) due to it being available in two strengths. Clinicians are urged to ensure that the correct insulin product and strength is prescribed and pharmacists should check again when the product is dispensed. It is also advised that patients are trained on how to use the device in particular they should always visually verify the dialled units on the dose counter.

This section also warns of the risk of cardiovascular and bleeding events associated with use of cilostazol (Pletal®). This drug is licensed for use to improve walking distances in patients with intermittent claudication. A recent safety review has concluded that the benefits of treatment are worthwhile in some, but not all patients. It is recommended that cilostazol is now used as second line treatment to lifestyle interventions and that it should not be use in patients with:

The hot topic section advises that clinicians remain vigilant to the potential for errors to occur as a result of drug name confusion. Recent examples of medicine names that have been confused resulting in medication errors include:

Finally, the stop press section advises of emerging cardiovascular safety concerns related to strontium ranelate (Protelos®). This drug is already associated with an increased risk of venous thromboembolism but recent analysis of randomised controlled trial data has identified an increased risk of cardiovascular events including myocardial infarctions. A full assessment of the risks and benefits will be carried out. In the meantime it is recommended that use of this drug is restricted to cases of severe osteoporosis, it should be avoided in patients who already have a cardiovascular disease and should only be used after careful consideration in those with risk factors for cardiovascular disease.

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