Important Safety Information about DEFLUX
Patients should not receive DEFLUX® (hyaluronic acid/dextranomer) if they have any of the following conditions: kidneys that don’t work (non-functional kidney[s]), bulging or herniation in the skin of the bladder (hutch diverticulum), swelling at the bottom of the ureter (ureterocele), a disorder in eliminating urine (active voiding dysfunction), and ongoing urinary tract infection.
Safety and efficacy of treatment in children under 1 year of age have not been established.
Safety and efficacy of treatment of duplex kidney systems have not been established.
There is a risk of infection and bleeding that is associated with the cystoscopy procedure used to inject DEFLUX.
Talk to your doctor if your child has ureters with grossly dilated orifices before receiving DEFLUX treatment.
DEFLUX should only be administered by qualified surgeons experienced performing urologic procedures.
In clinical studies, the most common side effects associated with DEFLUX (occurring < 1%) were: urinary tract infection (UTI), ureteral dilation, and nausea/vomiting/abdominal pain.
The following adverse events have been reported with Deflux: blockage of the ureters (some cases require temporary placement of a ureteric stent), painful urination, blood in the urine, urgency of urination, frequency of urination, swelling of the kidneys, inflammation of the kidneys, urinary tract infection, foreign body reaction, calcification, and fever.
You are encouraged to report negative side effects of DEFLUX to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, contact:
Palette Life Sciences
Medical Information Department