(RxWiki News) The US Food and Drug Administration (FDA) has approved the first drug for a certain type of bladder dysfunction in children.
This new approval is for VESIcare LS (solifenacin succinate).
VESIcare was initially approved in 2004 to treat adults with overactive bladder. Fast forward 16 years — this medication is now approved for kids with the same condition.
This drug has been approved to treat children (2 years old and older) with bladder dysfunction related to disease or injury of the nervous system. This condition is referred to as neurogenic detrusor overactivity (NDO). For some, NDO may be related to conditions that are present at or before birth, such as spina bifida.
“This is the first FDA-approved treatment for NDO patients as young as two years of age,” said Dr. Christine P. Nguyen, acting director of the FDA’s Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in a press release. “In addition, prior to today’s approval, the current standard of care for many of these patients required up to three times a day dosing, and this treatment requires only once a day dosing.”
With NDO, the bladder wall muscle is overactive. As a result, the bladder muscles contract irregularly. This then increases pressure in the bladder.
NDO can lead to an immediate urge to urinate, having to urinate more often than normal and a loss of bladder control.
If NDO is not treated, the increased pressure in the bladder can affect the urinary tract and possibly lead to permanent kidney damage.
Common side effects of VESIcare LS include constipation, dry mouth and urinary tract infections. Possible serious side effects include severe allergic reactions like angioedema (swelling beneath the skin) and anaphylaxis. These reactions may be life-threatening.
Seek immediate medical care if you notice your child's tongue or throat is swelling or that they are having trouble breathing.
The approval of this medication was granted to Astellas Pharma US, Inc.
Speak with your health care provider if you have any questions.
