FDA Adverse Event Report 3 -- Synvisc (H-G 20)

Lot Number 20501

Outcome: Required intervention

Event Description: Synvisc injected into left knee in 2006 over the course of one month, 3 times. Has marked increase in chemical sensitivities, especially to phenols, formaldehyde, and petroleum products. Reacts to print, plastic, gasoline fumes, cosmetics, clothes dryer sheets, etc. Resulting in upper respiratory allergies, increase in muscle and joint pain, cough, and asthmatic type symptoms. Patient confirmed that formaldehyde is used in the preparation of the product and it is not listed on the package label. Synvisc,, 2cc q 1 weekly x 3 intra-articularly.

July 28, 2006
Report date: 2/07/2007

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Event date: 12/1/2007
Patient outcome: hospitalization
Event Description: Blood clot in right leg. Pain in the ankle and right calf. Swelling in the ankle and right calf. Pain in the knee cap. Synvisc has not worked at all. Information was received on 12/10/2007 from a male patient who had a history of arthritis. The patient received a series of injections in both knees on the following dates: 2 times in the same month, and the following month in 2007. Starting 3 days later he experienced pain and swelling in his right calf and ankle, and in his knee cap. At the time of this report the patient had not yet recovered. Additional info was received on 2/13/2008 from pt. He reported that on 12/12/2007 he was hospitalized for 9 days due to a blood clot in his right leg, which was the same leg he reported as swollen calf. He stated that Synvisc did not work. At the date of this report, the patient had not yet recovered.


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Patient Outcome: Patient required intervention and required intervention

Event Description: Immune mediated systemic reaction (anaphylactic response), florid rash (rash). Case description received 3/11/2008 from a physician regarding a female patient, initials and age unknown. The patient received a 3 course series of Synvisc, and 2 months later she developed a florid rash and immune mediated systemic reaction. The patient required hospitalization and corticosteroids. The physician reported that the consensus is that it was due to Synvisc as the patient had no other causative factors. They had planned to "i&d" the joint but the patient had a recurrence of her symptoms which prompted emergent hospitalization.
At the date of the report, the patients outcome was unknown.