Myrbetriq Side Effects: Drug for Urinary Incontinence or Overactive Bladder. Are you one of 33 million Americans (and more than 200m people worldwide according to a dated 1998 figure from the World Health Organization) who suffer from urinary incontinence? Then you might be interested in a drug by Astellas Pharma named Myrbetriq (generic name: mirabegron) which is aimed at lessening your trips to the bathroom. The anti-urinary incontinence drug was approved today by the U.S. Food and Drug Administration.
What are the Myrbetriq side effects? Drug tend to have unintended side effects. The FDA lists the following Myrbetriq side effects:
- increased blood pressure
- common cold-like symptoms (nasopharyngitis)
- urinary tract infection
- constipation
- fatigue
- elevated heart rate (tachycardia)
- and abdominal pain
The list above may not be exclusive as it only includes those side effects observed during trial. It’s possible that other side effects will manifest as more people and more use the drug to temper their overactive bladders.
Safety and other pertinent information. Here’s some important information about the drug from the Myrbetriq media release issued by Astellas Pharma following the FDA’s approval of its newest medicine:
- The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within eight weeks; based on individual efficacy and tolerability, the dose may be increased to 50 mg once daily.
- Myrbetriq was evaluated for safety in more than 2,700 patients in three, 12-week Phase 3 doubleblind, placebo-controlled studies and in a one year, randomized fixed dose, active-controlled study in patients with OAB. The most commonly reported adverse reactions (greater than 2 percent of Myrbetriq patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection and headache.
- Myrbetriq can increase blood pressure. Periodic blood pressure determinations are recommended, especially in hypertensive patients. Myrbetriq is not recommended for use in severe uncontrolled hypertensive patients. (defined as systolic blood pressure ≥ 180mm Hg and/or diastolic blood pressure ≥ 110 mm Hg)
- Urinary retention in patients with bladder outlet obstruction (BOO) and in patients taking antimuscarinic medications for the treatment of overactive bladder (OAB) has been reported in postmarketing experience in patients taking mirabegron. A controlled clinical safety study in patients with BOO did not demonstrate increased urinary retention in Myrbetriq patients; however, Myrbetriq should be administered with caution to patients with clinically significant BOO. Myrbetriq should also be administered with caution to patients taking antimuscarinic medications for the treatment of OAB.
- When initiating a combination of Myrbetriq and digoxin, prescribe the lowest dose of digoxin; monitor serum digoxin concentration to titrate digoxin dose to the desired clinical effect.
- Most commonly reported adverse reactions were hypertension,nasopharyngitis, urinary tract infection and headache.
When is Myrbetriq going to be available?
Myrbetriq will be supplied in 25 mg and 50 mg tablets and is expected to be available in pharmacies in the fourth quarter of 2012. Mirabegron was approved in Japan in July 2011, and regulatory applications are under review in several other countries.
Some details for those of you interested in the clinical trials. The following is also copied from the media release:
- Myrbetriq was studied in patients who were primarily Caucasian (94 percent) and female (72 percent) with a mean age of 59 years (range 18 – 95 years). The population included both naïve patients who had not received prior antimuscarinic pharmacotherapy for OAB (48 percent) and those who had received prior antimuscarinic pharmacotherapy for OAB (52 percent).
- The approval of Myrbetriq was based on safety and efficacy data from three placebo-controlled Phase 3 studies, in which treatment with Myrbetriq 25 mg and 50 mg resulted in statistically significant improvement in efficacy parameters of incontinence episodes and number of urinations per 24 hours.
- In treatment with Myrbetriq 25 mg, incontinence episodes were reduced by 1.36 episodes from a baseline of 2.65, a statistically significant reduction of 0.40 vs. placebo in 12 weeks. The number of urinations was reduced by 1.65 urinations from a baseline of 11.68, a statistically significant reduction of 0.47 vs. placebo in 12 weeks.
- In treatment with Myrbetriq 50 mg, incontinence episodes were reduced by 1.49 episodes from a baseline of 2.71, a statistically significant reduction of 0.40 vs. placebo in 12 weeks. Number of urinations was reduced by 1.75 urinations from a baseline of 11.70, a statistically significant reduction of 0.55 vs. placebo in 12 weeks.
- Myrbetriq was evaluated for safety in more than 2,700 patients in three, 12-week Phase 3 doubleblind, placebo-controlled studies and in a one year, randomized fixed dose, active-controlled study in patients with OAB. The most commonly reported adverse reactions (greater than 2 percent of Myrbetriq patients and greater than placebo) were hypertension, nasopharyngitis, urinary tract infection and headache.
So there! Now you know some Myrbetriq side effects and are a little more informed about how the trial to determine the effectiveness and safety of the drug has been conducted.
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Myrbetriq Side Effects: Drug for Urinary Incontinence or Overactive Bladder posted 29 June 2012. Last update on 29 June 2012.