The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2016 (PDF).
Nicorandil is now placed a second-line treatment, after beta-blockers or calcium channel blockers, for stable angina due to the risk of ulceration. It can cause serious skin, mucosal and eye ulceration, including gastrointestinal ulcers which may progress to perforation, haemorrhage, fistula, or abscess and treatment must be stopped if ulceration occurs.
Clinicians are advised that levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because there are license differences. Mirena has been available for several years but recently a new product called Levosert was licensed. For contraception or heavy menstrual bleeding Mirena is licensed for 5 years of use while Levosert is licensed for 3 years. In addition Mirena is licensed for endometrial protection while Levosert is not. Additionally, there are differences in the insertion techniques between the two products. Prescribing by brand name will ensure the correct and expected product is supplied.
This issue also contains a summary of letters sent to healthcare professionals in December 2015. Galantamine has been associated with serious skin reactions including Stevens Johnson Syndrome (SJS), acute generalised exanthematous pustulosis (AGEP) and erythema multiforme. It is recommended that patients and carers are advised to monitor for skin reactions. In the advent of an apparent skin reaction patients should be advised to stop treatment and seek medical advice.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.