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Hyalgan® (hyaluronate) was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with Hyalgan® (hyaluronate) ; 168 with placebo; and 163 with naproxen) (refer to Table 1).
Incidence1 of Adverse Events Occuring in More Than 5% of All Subjects
|Adverse Event|| Hyalgan®
|Gastrointestinal complaints2||48 (29%)||59 (36%)|
|Injection site pain3||38 (23%)4||22 (13%)|
|Headache||30 (18%)||29 (17%)|
|Local skin5||23 (14%)||17 (10%)|
|Local joint pain and swelling6||21 (13%)||22 (13%)|
|Pruritus (local)||12 (7%)||7 (4%)|
1 Notes: Number and % of subjects
2 Severe in 4 Hyalgan® (hyaluronate) -treated subjects and 4 placebo-treated subjects
3 Severe in 5 Hyalgan® (hyaluronate) -treated subjects and 2 placebo-treated subjects
4 Statistically significant (p=0.02)
5 Includes ecchymosis and rash
6 Severe in 2 Hyalgan® (hyaluronate) -treated subjects (1.2%) and 1 placebo-treated subject
Common adverse events reported for the Hyalgan® (hyaluronate) -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® (hyaluronate) and placebo-treated groups. Hyalgan® (hyaluronate) -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® (hyaluronate) -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® (hyaluronate) -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® (hyaluronate) -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® (hyaluronate) -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® (hyaluronate) has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of Hyalgan® (hyaluronate) 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® (hyaluronate) treatment was discontinued and both had favorable outcomes. Three cases of allergic reactions were reported in which the patients were discontinued from Hyalgan® (hyaluronate) 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® (hyaluronate) treatment and all incidents resolved. One incident of shock (which was described as a "hypotensive crisis") was reported. The incident resolved and Hyalgan® (hyaluronate) treatment was continued.
Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with Hyalgan® (hyaluronate) . 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 »
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Last reviewed on RxList: 12/15/2008
This monograph has been modified to include the generic and brand name in many instances.
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