The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2015 (PDF).
Clinicians are advised that mirebegron (Betmiga®) is now contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both) following an EU-wide review of the latest safety data. It is also recommended that blood pressure should be measured before starting treatment and monitored regularly during treatment, especially in patients with hypertension.
It is also noted in this edition that a letter informing of a risk of severe hypertension and associated cerebrovascular and cardiac events linked with mirebegron use was sent to healthcare professionals in September.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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