Dear Healthcare Professional Letter on the new recommendations due to a risk from increased blood pressure with the use of mirabegron (Betmiga)
04.09.2015
Astellas, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) is informing healthcare professionals on the new recommendations for use of mirabegron (Betmiga) due to a risk of increased blood pressure.
Summary
- serious cases of hypertension and increased blood pressure have been observed in patients treated with mirabegron
- mirabegron is now contraindicated in patients with severe uncontrolled hypertension, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.
- blood pressure should be measured before treatment and controlled regularly during treatment, especially in patients with hypertension.
Further information
Mirabegron is used in adults with overactive bladder syndrome. It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt). The high blood pressure is a known risk for mirabegron and it is included in the product information. New recommendations follow to the review of all data related to mirabegron and increased blood preassure conducted by the EMA. Serious cases of hypertension and increased blood pressure have been identified in patients treated with mirabegron. In addition, cases of hypertension crises and cerebrovascular and heart events associated with hypertension have been reported with a clear time relation with the use of mirabegron. In certain cases, limited information was available or other concomitant factors were indicated. Therefore, the use of mirabegron is now contraindicated in patients with uncontrolled high blood pressure. The blood pressure should be controlled in the beginning of treatment and monitored during treatment, especially in patients with hypertension.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
