Synvisc/Synvisc-One Adverse Reactions

Adverse events involving the injected joint: transient pain and/or, swelling and/or effusion in the injected joint may occur after intra-articular injections of Hylan G-F 20. Cases of acute inflammation, characterized by joint pain, swelling, effusion and sometimes joint warmth and/or stiffness, have been reported following an intra-articular injection of Synvisc/Synvisc-One. Analysis of synovial fluid reveals aseptic fluid with no crystals. This reaction often responds within a few days to treatment with Non Steroidal Anti Inflammatory Drugs (NSAIDS), intra-articular steroids and/or arthrocentesis. Clinical benefit from the treatment may still be apparent after such reactions.
Intra-articular infections did not occur in any of the clinical trials of Synvisc/Synvisc-One and have been reported only rarely during clinical use of Synvisc.
Hypersensitivity reactions including anaphylactic reaction, anaphylactoid reaction, anaphylactic shock and angioedema have also been reported.
Synvisc: The post marketing experience has identified the following systemic events to occur rarely with Synvisc administration: rash, hives, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral oedema, malaise, respiratory difficulties, flushing and facial swelling.
In the controlled clinical trials with Synvisc, there were no statistically significant differences in the number or types of systemic adverse events between the group of patients that received Synvisc and the group that received control treatments.
Synvisc-One: In the controlled clinical trial with Synvisc-One, the frequency and types of adverse events were similar between the group of patients that received Synvisc-One and the group that received placebo.