HYALGAN® Safety

Demonstrated safety, again and again10,26

  • Nonsystemic treatment option that targets the knee, not the whole body21
  • No known drug-drug interactions26
  • In clinical studies, no significant difference in frequency and severity of cardiovascular events between patients treated with HYALGAN® and control18
  • Long-term safety in a 30-month repeat-use study25
  • No reported pseudoseptic reactions in clinical trials*

* Based on MEDLINE, TOXLINE, EMBASE, INTERNATIONAL PHARMACEUTICAL ABSTRACTS, and BIOSIS, DERWENT DRUG FILE, ELSEVIER BIOBASE, and BRITISH LIBRARY INSIDE CONFS literature searches as of May 2007.

HYALGAN® is an FDA-approved product with a well-established safety profile21,26


Repeat treatment for continuous, reliable relief
  • No significant increase in adverse events with repeat cycles of HYALGAN®25
Safety and efficacy demonstrated
throughout 30 months2

Chart demonstrating Safety and efficacy throughout 30 months

Adapted from Scali JJ.

Study design

30-month, repeat use, open-design study (N=75) of IA HYALGAN® 20 mg weekly x 5, repeated every 6 months for 5 treatment cycles. One cycle = 5 injections.25

As measured using 100-mm VAS.

Pain relief with HYALGAN® compared with baseline.


Important Safety Information for HYALGAN®

  • HYALGAN® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpha-rmacologic therapy, and to simple analgesics, eg, acetaminophen
  • HYALGAN® is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injections are contraindicated in cases of past and present infections or skin diseases in the area of the injection site
  • The effectiveness of a single treatment cycle of less than 3 injections has not been established
  • In the US clinical trial of 495 patients, the only adverse event showing statistical significance vs placebo was injection-site pain
  • Other adverse events included gastrointestinal complaints, headache, local ecchymosis and rash, local joint pain and swelling, and local pruritus. However, the incidence of these events was similar in the HYALGAN®-treated and placebo groups
  • In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle

Click here for additional important information for HYALGAN®.