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Safety established over two decades of use

Deflux has been used for more than two decades to treat vesicoureteral reflux (VUR) grades II-IV in children.

Incidence of adverse events occurring >1% of patients1
Adverse Event Category Pivotal study N=39 Supportive Studies N=170 Post-Approval Study N=165
UTI 6 (15.4%) 13 (7.6%) 3 (1.8%)
Ureteral Dilatation 1 (2.6%) 6 (3.5%) 0 (0%)
Nausea, Vomiting, or Abdominal Pain 0 (0%) 2 (1.2%) 0 (0%)

UTI = urinary tract infection.

The following adverse events have been reported with Deflux (occurring 1%): ureteral obstruction (some cases requiring temporary placement of a ureteric stent), dysuria, hematuria, urgency, frequency, hydronephrosis, pyelonephritis, urinary tract infection, foreign body reaction, calcification and pyrexia.

References:

  1. Deflux [prescribing information]. Santa Barbara, CA: Palette Life Sciences, Inc.; 2019.