FDA Approves New Treatment for Bladder Dysfunction in Pediatric Patients - Drug Information Update

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FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

The U.S. Food and Drug Administration today granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older. VESIcare (solifenacin succinate) tablets were initially approved in 2004 for the treatment of overactive bladder in adults 18 years and older. The most common side effects of VESIcare LS are constipation, dry mouth and urinary tract infection. Somnolence (sleepiness or drowsiness) has been reported with solifenacin succinate, the active ingredient in VESIcare LS. Patients of age who are able to drive or operate heavy machinery should not do so until they know how VESIcare LS affects them. Health care professionals are advised not to exceed the recommended starting dose of VESIcare LS in patients also taking strong CYP3A4 inhibitors. Severe allergic reactions, such as angioedema (swelling beneath the skin) and anaphylaxis, have been reported in patients treated with solifenacin succinate and may be life threatening. Patients should seek immediate attention if they experience swelling of the tongue or throat or difficulty breathing. VESIcare LS is not to be used in patients with gastric retention (reduced emptying of the stomach), uncontrolled narrow angle glaucoma (fluid buildup in the eye which raises eye pressure) or hypersensitivity (allergic reaction) to VESIcare LS or any of its components. VESIcare LS is also not recommended for use in patients with severe liver failure, clinically significant bladder outlet obstruction in the absence of clean intermittent catheterization, decreased gastrointestinal motility (slowed intestinal contractions), or at high risk of QT prolongation (an electrical disturbance where the heart muscle takes longer than normal to recharge between beats), including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval.

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