Synvisc: reported incidents of joint inflammation and pain


Hylan G-F 20 ( Synvisc ) is an elastoviscous fluid containing hylan polymers, which are derivatives of hyaluronan ( sodium Hyaluronate).
It is indicated for the treatment of pain caused by osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics.

A treatment course involves intra-articular injection once a week for 3 weeks.

Aspiration of synovial fluid or effusion should be performed before each injection.

The most commonly reported adverse incidents have been pain, swelling and effusion in the injected knee.

From Mar. 22, 1996, to Jan. 15, 2005, Health Canada received 31 reports of suspected incidents associated with Synvisc; 23 were received in 2003-2004.

In 9 cases the synovial fluid was not removed before each injection, and in 5 the course of injection was continued after the occurrence of adverse symptoms.

Six of the 23 recent reports described patients who had pain, walking disability and knee swelling with or without effusion after the third injection of the first course.
Two of these 23 patients were admitted to hospital.

The occurrence of post-injection effusion may be associated with the number of injections.

There have been reports in the literature of pseudosepsis ( severe inflammation of the joint occurring 24 to 72 hours after intra-articular injection of hylan ) .
In affected patients, pseudosepsis typically occurs after more than 1 injection.
Sepsis or pseudogout should be ruled out.
Mononuclear cells are present in the synovial fluid.

Although the cause of pseudosepsis is not fully understood, there is increasing evidence to suggest an immunologic mechanism.

Health Care Professionals should be aware of these possible adverse incidents and encouraged to follow the labelled procedure, including aspiration of synovial fluid before each injection.

Patients should be alerted of the occurrence of such events, and those who have severe inflammation of the joint after an injection should be fully evaluated.

Source: Health Canada, 2005


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