FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients The U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients. NDO is a dysfunction of the bladder that results from congenital conditions (inherited conditions beginning at or before birth), such as spina bifida, or other disease or injury in the nervous system, such as spinal cord injury. With NDO, there is overactivity of the bladder wall muscle, which normally relaxes to allow storage of urine. The bladder wall muscle overactivity in NDO results in sporadic bladder muscle contraction, which increases pressure in the bladder and decreases the volume of urine the bladder can hold. If NDO is not treated, increased pressure in the bladder can put the upper urinary tract at risk of harm, including possible permanent damage to the kidneys. In addition, spontaneous bladder muscle contractions can lead to unexpected and frequent leakage of urine with symptoms of urinary urgency (immediate need to urinate), frequency (urinating more often than normal) and incontinence (loss of bladder control). The most common side effects with Myrbetriq and Myrbetriq Granules with NDO were urinary tract infection, nasopharyngitis (common cold), constipation and headache. Myrbetriq and Myrbetriq Granules may increase blood pressure and may make blood pressure worse in patients with a history of high blood pressure. Myrbetriq and Myrbetriq Granules may cause angioedema, an allergic reaction with swelling of the lips, face, tongue or throat. Patients should promptly discontinue Myrbetriq and Myrbetriq Granules and seek medical attention if angioedema associated with upper airway swelling occurs, as this may be life-threatening. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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