FDA Adverse Event / Side-Effect Report 5 -- Synvisc (H-G 20)

Event Date 01/27/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Lack of muscle strength [muscular weakness]. Unable to roll over or get out of bed (mobility decreased) [mobility decreased]. Unable to ambulate [abasia]. Whole body locked up like an allergic reaction [hypersensitivity]. Case description: a spontaneous report received on 06-feb-2009 from the designee of a female patient with a history of arthritis, who experienced lack of muscle strength, decreased mobility, inability to ambulate, or her "whole body locked up like an allergic reaction" after starting synvisc. The patient received an injection of synvisc into the left knee the month prior. On the next day, the patient experienced a lack of muscle strength, she was unable to roll over or get out of bed, and unable to walk. The reporter commented that the patient's "whole body locked up like an allergic reaction". The patient stayed in bed the remainder of the week. On the following month, she was admitted to the hospital by her primary care physician. At the time of this report the outcome of the patient was unknown.

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Event Date 02/05/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Pt is a woman who had synvisc placed in knee in office in late 2008. He started to feel gradually worse, and ended up hospitalized in serious condition with bilateral pleural effusions and pericardial effusion with essentially whole body reaction and inflammation. Pt responded quickly to large dose prednisone, and over the course of 6 weeks was gradually weaned off, and currently feels well. Three injections to right knee over 3 weeks of synvisc. Dates of use: 2008, 3 weeks - 3 injections. Diagnosis or reason for use: arthritis right knee. Event abated after use stopped or dose reduced? yes.

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Lot Number NOT PROVIDED
Event Date 08/31/2008
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Event verbatim [preffered term] (related symptoms if any separated by commas). Arthroscopic surgery of right knee [arthroscopic surgery]; could barely walk [gait disturbance]; swollen right knee [joint swelling]; fluid in right knee [joint effusion]; pain in right knee/worse than before synvisc [arthralgia]. Case description: spontaneous report received on 20-nov-2008 from a female patient, initials t-h, who had a relevant medical history of arthritis of the knee and right knee pain. The patient received a series of synvisc injections in her right knee four months earlier. There were 2 weeks in between her first and second injections (the same month) and 1 week in between her second and third injections, with her last injection received in the same month. After she received her third injection, the patient rested for a few days as advised by her physician. The third injection given, her right knee became swollen and full of fluid. She experienced "severe" pain in the right knee and she could barely walk. She contacted her physician that same sunday, and he had her see him in the office. The physician drained the fluid in her right knee and had the fluid "tested". The patient saw the physician again for follow-up the following month, and he had to drain the right knee again. The physician then admitted the patient into the hospital on that thursday (same day). The next day, the patient had arthroscopic surgery in the right knee and stayed in the hospital for 5 days. She started physical therapy while in the hospital and was discharged with follow-up at her home by a visiting nurse and further physical therapy. She had to use a walker to get around at home. About 3-4 days after going home, her right knee had to be drained again. The right knee was drained about every 4-5 days after that for about 4 times total. She continued to have to use a cane to get around at home. She also continued to have pain, which was "more severe" than the pain she had before receiving synvisc. She said that she experienced "every side effect listed in the synvisc information" (she declined to clarify), so she felt that there was "something wrong with synvisc". She claimed that her life was "ruined". As of the date of receipt of this report the patient outcome was not yet recovered.