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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. Usually such symptoms disappear within a few days by resting the affected joint and applying ice locally. Only sporadically have these events been more severe and longer lasting. Very rare cases of intra-articular infection have been reported. Strict aseptic technique must be followed in administering Hyalgan®. Systemic allergic reactions rarely have been recorded. Isolated cases of an anaphylactic or anaphylactic-like reaction have been reported in post-marketing experience and they all resolved. Allergic-type signs and symptoms such as rash, pruritus, and urticaria also are very rare. A few cases of fever were reported. In some instances, they were associated with local reactions, in other cases, no association other than temporal was found with the use of the product.
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).
Read the Hyalgan (hyaluronate) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/15/2016
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