Hyalgan Side Effects, and Drug Interactions - Hyaluronate

Hyalgan Side Effects, and Drug Interactions - Hyaluronate

SIDE EFFECTS

HyalganŽ was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with HyalganŽ; 168 with placebo; and 163 with naproxen) (refer to Table 1). Common adverse events reported for the HyalganŽ-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 HyalganŽ- and placebo-treated groups. HyalganŽ-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 HyalganŽ-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 HyalganŽ-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%) HyalganŽ-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 HyalganŽ-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.

HyalganŽ has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of HyalganŽ 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, HyalganŽ treatment was discontinued and both had favorable outcomes. Three cases of allergic reactions were reported in which the patients were discontinued from HyalganŽ 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 HyalganŽ treatment and all incidents resolved. One incident of shock (which was described as a "hypotensive crisis") was reported. The incident resolved and HyalganŽ treatment was continued.

Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with HyalganŽ. 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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