The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2015 (PDF).
Clinicians are advised that amiodarone use has been associated with severe bradycardia and heart block when used with simeprevir (Olysio®) and sofosbuvir (Sovaldi®) combination therapy for chronic hepatitis C. Amiodarone is only recommended in this combination when all other antiarrhythmics cannot be given. When there is no alternative very careful monitoring is recommended. Patients should be advised to report symptoms of bradycardia including shortness of breath, light-headedness, palpitations and fainting.
Finally this month there is a summary of letters sent to healthcare professionals in July 2015, including one regarding the risk of diabetic ketoacidosis observed with SGLT2 inhibitors and one regarding the new contraindication for denosumab in patients with unhealed lesions from dental or oral surgery and the introduction of patient safety cards about osteonecrosis of the jaw. Both of these items have been covered in previous Drug Safety Updates.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.