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

http://www.accessdata.fda.gov/

The following adverse event / side-effect was reported to the FDA Maude site for Synvisc manufactured by Genzyme.

Event Date: 11/29/2007

Event description: Medwatch, date 12/12/2007, was received by the fda via a corep on 8/26/2008. The report concerned a male who reported muscle spasms, muscle pain, contractions of entire body, suffocation, tingling, itching, and numbness of entire body, neuropathy, hot sweats, redness at injection site, tenderness at injection site, swelling at injection site, systemic reaction attacking nervous system, dizziness, weakness of left side of body, difficulty speaking, difficulty walking and symptoms of stroke after starting Synvisc. The reported of the event is the pt's wife. The patient recieved one injection of Synvisc at unknown site the prevous month at the doctor's office. At the time of injection, the patient experienced a pronounced muscle spasm. One hour later, pt experienced muscle spasms in back, pain and contractions of entire body, and contractions of temporal mandibular joint that caused the patient to suffocate. The pt reported pulling on his beard to release the mandibular joint contraction. He also experienced numbness, tingling, and itching of his entire body as well as hot sweats...On the same day, the pt went to the emergency room where the dr reportedly diagnosed the pt with a systemic reaction attacking the nervous system. The pt reported the reaction the drs. On the following month, the pt was admitted to the hospital with symptoms of stroke, dizziness, weakness to the left side of his body, difficulty speaking, difficulty walking. At the time of report, outcome is unknown.


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