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British Health Regulator Warns of Heart and Stroke Risks with Overactive Bladder Drug Myrbetriq

Oct 21, 2015

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety update for the medication mirabegron (Betmiga in the U.K., Myrbetriq in the U.S.) prescribed for overactive bladder syndrome.

The U.K. health regulator advises that mirabegron is contraindicated for patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both). Mirabegron can increase blood pressure and cases of severe hypertension have been reported, with reports of cerebrovascular and cardiac events.

Mirabegron was approved in 2012 in both the U.S. and the U.K. for the treatment of urinary frequency, urgency, and incontinence in people with overactive bladder syndrome. Mirabegron (Betmiga) is a beta 3-adrenoceptor agonist. The update from the MHRA says approximately 700,000 packs of mirabegron have been dispensed in the U.K. since the drug was licensed in December 2012. A review across the European Union of the latest safety data for mirabegron has led to new measures to help reduce the risks of severe hypertension. Mirabegron can increase blood pressure and cases of severe hypertension have been reported, which include reports of cerebrovascular and cardiac events (mainly transient ischemic attacks or stroke). Some of these reports indicated a clear temporal relation to mirabegron use, the MHRA said.

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 (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) and it should therefore be used with caution in this group. Mirabegron is not recommended in patients with severe renal impairment (GFR 15–29 mL/min/1.73 m2) or in those with moderate liver impairment (Child-Pugh Class B) who are also taking strong inhibitors of cytochrome P450 3A such as itraconazole, ketoconazole, ritonavir, or clarithromycin.

In the U.S., the Food and Drug Administration (FDA) has made labeling changes to Myrbetriq because of instances of angioedema, swelling that is similar to hives, but occurs under the skin instead of on the surface. The FDA says in some cases angioedema of the face, lips, tongue, and/or larynx has occurred after the first dose. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, the patient should promptly discontinue Myrbetriq and initiate appropriate therapy and/or measures necessary to ensure a patent airway.


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