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A well-documented safety profile
In clinical studies, adverse events common to intra-articular treatment were comparable between SUPARTZ FX and saline-treated patients40-43
- In these studies, more people discontinued treatment with saline placebo than those who received SUPARTZ FX therapy40
- Pseudoseptic (acute inflammatory) reactions have NOT been reported in 20 prospective randomized controlled trials of
SUPARTZ FX therapy44
- The FDA reviewed data on more than 8,000 patients prior to approving SUPARTZ FX in the United States39
SUPARTZ FX offers a safety profile similar to saline placebo
Adverse events occurred at similar rates in patients treated with SUPARTZ FX and those treated with a saline placebo in an integrated analysis of multiple clinical studies. No serious injection site adverse events were reported and no allergic reactions due to SUPARTZ FX were reported.40
- Results of integrated analysis of 5 clinical trials with 1,155 patients showed SUPARTZ FX had adverse events and discontinuation rates similar to saline placebo
- Comparable incidence of adverse events following SUPARTZ FX versus saline placebo40,42
- Discontinuation rates due to adverse events were 1.8% for SUPARTZ and 3.2% for placebo40
- No reports of pseudoseptic reactions in the scientific literature‡44
‡Does not include current prescribing experience.
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SUPARTZ FX contains virtually no detectable impurities
- A study of impurities in hyaluronic acid (HA) products found that SUPARTZ FX has less protein content than other HA products46
- SUPARTZ FX also had significantly less bacteria endotoxin content and significantly less nucleic acids/DNA content compared with other HA products46