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# Allergan’s Botox OK’d for Pediatric Bladder Condition
- URL: https://www.fdaweb.com/allergans-botox-okd-for-pediatric-bladder-condition/
- Published: 2021-02-10T12:00:00.000Z
- Updated: 2026-09-14T16:46:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148639

FDA has approved Allergan’s Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients aged five years and older who have an inadequate response, or are intolerant, to anticholinergic medications. Allergan says that neurogenic detrusor overactivity occurs when the spinal cord and bladder are not able to communicate effectively, which can occur with neurologic conditions such as spina bifida and spinal cord injuries. This can result in the bladder muscle involuntarily contracting, increasing the pressure in the bladder and reducing the bladder capacity, which can cause a frequent and unexpected urine leak. Elevated bladder pressure can also lead to bladder and kidney damage over time, the company says.

Approval is based on data from a randomized, double-blind Phase 3 study evaluating the safety and efficacy of Botox in more than 100 pediatric patients with neurogenic detrusor overactivity, which demonstrated the drug reduced daytime urinary incontinence episodes, lowered maximum bladder pressure and increased bladder capacity, according to the company. The most common adverse reactions observed in patients were bacteriuria (20%), urinary tract infection (7%), leukocyturia (7%), and hematuria (3%).