Deflux safety established over two decades of use
Since 2001, Deflux has been used to treat vesicoureteral reflux (VUR) grades II-IV in children in the United States.
Deflux is the only injectable agent for VUR approved in the United States, Australia, Europe and New Zealand.
| 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.
Latex-free statement
The components used for the manufacturing of Deflux injectable gel are free from Latex.
Please see the product insert for full safety information.
