ADR that result in revision of patient information
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The United Kingdom: Mirabegron (Betmiga): risk of severe hypertension and associated cerebrovascular and cardiac events |
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Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
Mirabegron (Betmiga) is a beta 3-adrenoceptor agonist used in the management of urinary frequency, urgency, and incontinence in overactive bladder syndrome. Approximately 700,000 packs of mirabegron have been dispensed in the UK since it was first licensed in December 2012.
An EU-wide review of the latest safety data for mirabegron has led to new measures to help reduce the risks of severe hypertension. It is already known that mirabegron can increase blood pressure. However, cases of severe hypertension have been reported, which include hypertensive crisis associated with reports of cerebrovascular and cardiac events (mainly transient ischaemia attack or stroke)—some with a clear temporal relation to mirabegron use.
Mirabegron is now contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both). Regular monitoring of blood pressure is important, especially in patients with pre-existing hypertension.
Data are limited regarding use of mirabegron in patients with stage 2 hypertension (ie, systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) and it should therefore be used with caution in this group.
As for some other patient subgroups, Mirabegron is not recommended in patients with severe renal impairment (ie, GFR 15–29 mL/min/1.73 m2) or in those with moderate hepatic impairment (ie, Child-Pugh Class B) who are also taking strong inhibitors of cytochrome P450 3A such as itraconazole, ketoconazole, ritonavir, or clarithromycin. The dose of mirabegron in patients with mild to moderate renal impairment (ie, GFR 30–89 mL/min/1.73 m2) or those with mild hepatic impairment (ie, Child-Pugh Class A) who are also taking strong inhibitors of cytochrome P450 3A should be reduced to 25 mg once daily.
Healthcare professionals are advised of the following key safety updates:
• Mirabegron is contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)
• Blood pressure should be measured before starting treatment and monitored regularly during treatment, especially in patients with hypertension
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/mirabegron-betmiga-risk-of-severe-hypertension-and-associated-cerebrovascular-and-cardiac-events
In Hong Kong, there are two registered pharmaceutical products containing mirabegron, namely Betmiga Prolonged-release Tab 25mg (HK-62460) and 50mg (HK-62461). Both products are prescription-only medicines registered by Astellas Pharma Hong Kong Company Limited. So far, the Department of Health has not received any adverse drug reaction case on mirabegron. In view of the MHRA's announcement, letters to inform local healthcare professionals of the risk will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, October 15, 2015
Issued at HKT 14:00
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