Supartz Side Effects

Generic Name: sodium hyaluronate

Please note - some side effects for Supartz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Supartz - for the Consumer

Supartz

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Supartz:

Back pain; mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Side Effects by Body System

General

Most side effects are related to local reactions such as injection site pain, pain, swelling, effusion, or redness of the joint.

Increased risk, severity, or frequency of side effects does not appear to occur with retreatment of sodium hyaluronate.

Local

Local side effects for sodium hyaluronate in relation to placebo therapy have included injection site pain (23% vs 13%), joint pain and swelling (13% vs 13%), and local skin reactions consisting of ecchymosis and rash (14% vs 10%) and pruritus (7% vs 4%). Warmth and redness have also been reported.

Injection site pain was listed as the reason for premature discontinuation of treatment in 4% (6/164) of the patients treated with sodium hyaluronate as compared to < 1% (1/164) of placebo-treated patients.

Patients with inflammatory arthritis may experience transient increases in inflammation of the injected knee following treatment.

Hypersensitivity

Hypersensitivity reactions have included 2 cases of anaphylactoid reactions and 3 cases of allergic reactions, which resolved upon discontinuation of sodium hyaluronate.

Hypersensitivity side effects have included anaphylactoid reactions and allergic reactions.

Other

Seven cases of fever were reported in one pivotal clinical study. Subsequently, 3 of these cases were reported to be associated with local reactions. No association to pyrogenic arthritis was found.

Other side effects have included fever and headache.

Gastrointestinal

Gastrointestinal side effects for sodium hyaluronate in relation to placebo therapy have included unspecified complaints (29% vs 36%).

Non-specific gastrointestinal complaints were severe in both 4% of patients treated with sodium hyaluronate and 4% of patients treated with placebo.

Cardiovascular

Cardiovascular side effects have included hypotensive crisis or shock.

There has been one case report of hypotensive crisis or shock, which resolved and did not reoccur with repeated treatment.

Musculoskeletal

Pseudosepsis has been characterized as severe joint inflammation with pain and effusion occurring 24 to 72 hours after injection and it may be more likely to occur after the second or third injection or with repeated courses. Nonsteroidal anti-inflammatory drugs, intra-articular steroids, and/or arthrocentesis are often required to treat pseudosepsis.

In a pivotal clinical study 1.2% (2/164) patients treated with sodium hyaluronate vs. 1.8% (3/164) patients treated with placebo were reported to have a positive bacterial culture of effusion aspirated from the treated knee. Only 1 of the placebo-treated patients required hospitalization for presumptive treatment for septic arthritis. The remaining 4 patients did not show clinical or subsequent signs of infection.

Musculoskeletal side effects have included knee swelling/effusion and pseudosepsis.

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