Hyalgan® was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with Hyalgan®; 168 with placebo; and 163 with naproxen) (refer to Table 1). Common adverse events reported for the Hyalgan®-treated subjects were gastrointestinal complaints, injection site pain, knee swelling/effusion, local skin reactions (rash, ecchymosis), pruritus, and headache. Swelling and effusion, local skin reactions (ecchymosis and rash), and headache occurred at equal frequency in the Hyalgan®- and placebo-treated groups. Hyalgan®-treated subjects had 48/164 (29%) incidents of gastrointestinal complaints that were not statistically different from the placebo-treated group. A statistically significant difference in the occurrence of pain at the injection site was noted in the Hyalgan®-treated subjects: 38/164 (23%) in comparison to 22/168 (13%) in the placebo-treated subjects (p = 0.022). There were 6/164 (4%) premature discontinuations in Hyalgan®-treated subjects due to injection site pain in comparison to 1/168 (<1%) in the placebo-treated subjects. These differences were not statistically significant.

Two (2/164, 1.2%) Hyalgan®-treated subjects and 3/168 (1.8%) placebo-treated subjects were reported to have positive bacterial cultures of effusion aspirated from the treated knee. The two Hyalgan®-treated subjects and two of the placebo-treated subjects did not exhibit evidence of infection clinically or subsequently and were not treated with antibiotics. One of the placebo-treated subjects was hospitalized and received presumptive treatment for septic arthritis.

Hyalgan® has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of Hyalgan® in Europe reveals that most of the events are related to local symptoms such as pain, swelling/effusion, and warmth or redness at the injection site. In the two events reported as anaphylactoid reactions, Hyalgan® treatment was discontinued and both had favorable outcomes. Three cases of allergic reactions were reported in which the patients were discontinued from Hyalgan® treatment and the incidents resolved. Seven cases of fever were reported in which three of the cases were reported to be associated with local reactions; pyogenic arthritis was reported to be ruled out in these three cases. All the fever patients were discontinued from Hyalgan® treatment and all incidents resolved. One incident of shock (which was described as a "hypotensive crisis") was reported. The incident resolved and Hyalgan® treatment was continued.

Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with Hyalgan®. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. (Carrabba et al., 1995; Carrabba et al., 1991; Kotz and Kolarz, 1999; Scali, 1995).

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