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betmigaOctober 19 2015

Mirabegron, available as Betmiga, should not be used in patients with severe uncontrolled hypertension, the medicines regulator has advised.

The drug is now contraindicated in patients where:

  • the systolic blood pressure is 180mm Hg or above; or
  • the diastolic pressure is 110mm Hg or above;
  • or both.

The MHRA has issued a drug safety update saying the medicine, used for urinary frequency and incontinence in over-active bladder, should be monitored regularly due to the possibility of severe hypertension occurring.  

The advice follows an EU-wide review of the drug which is still monitored under the Black Triangle scheme having been licensed in December 2012. This has identified cases of severe hypertension which has in some case lead to cerebrovascular or cardiac events, including transient ischaemic attacks and stroke.

In addition, as data is limited, mirabegron should be used with caution in stage 2 hypertension, where:

the systolic blood pressure is 160mm Hg or above; or
the diastolic pressure is 100mm Hg or above.

It is not recommended for use in patients with severe renal impairment or in certain circumstances with moderate hepatic impairment. “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,” says the MHRA.

Astellas, the manufacturer of Betmiga has also written to health professionals about the new recommendations in use. The MHRA is asking that any suspected side effects to mirabegron are reported via the Yellow card scheme.

Links:

MHRA drug safety update

Astellas letter to health professionals

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