The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2015 (PDF).
Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced for Denosumab (Prolia®, Xgeva®) and intravenous bisphosphonates. Additionally, denosumab 120mg (Xgeva®) is now contraindicated in patients with unhealed lesions from dental or oral surgery.
The Xalatan® formulation of latanoprost has recently been changed such that the pH is now 6.0 compared to 6.7 previously. This change allows for longer term storage at room temperature however it has also been associated with an increase in reporting of eye irritation. Patients as advised to tell their health professional promptly (within a week) if they have eye irritation (e.g. excessive watering) severe enough to make them consider stopping treatment.
Finally this month there is a summary of letters sent to healthcare professionals in June 2015, including one for the oral anticoagulant edoxaban.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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