FDA Adverse Event / Side-Effect Report 4 -- Synvisc (H-G 20)

Synvisc injections--series of 3 injections in right knee. Could not straighten out knee due to bone spurs. Side-effect--muscle weakness in arms; could not lift arms above shoulders. Pain above shoulders and across back, excruciating spasms in thighs for 45 minutes at a time on 4 nights. Tachycardia on 6 mornings from 5 am to 5:30 am, pain in ribs on right side, aches and pains all over, could not sit in easy chair for more than a half hour at a time, spent most of my time in bed propped up with pillows, very sleepy. Symptoms disappeared all at once 4 weeks after first injection...I could not do much of anything for a month. My orthopedic surgeon said that the reactions I had were not from the Synvisc injections, but after reading about other people's reactions, I'm convinced the Synvisc caused these adverse reactions...

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Event date 1/13/2006

Shortness of breath, hives and itching all over body, swollen face, swollen eyes, right knee swelling. Report received on 4/12/2006 from a physician via a nurse re: female patient with initials K-P with a history of osteoarthritis...pt began treatment in 12/28/2005. The pt received a series of 3 injections into the rt knee on 12/28/2005, 1/4/2006 and 1/11/2006. The pt experienced hives and itching beginning 2 days after 3rd injection. She was treated with predinosone which helped for about 18 hrs, and then the hives and itching returned. Other antihistamines did not work. On 4/12/2006 her face and eyes were swollen. The pt had not taken any other medications during or after the Synvisc treatment period, except for treatment of the reaction. The patient has no known allergy to chicken products but does have allergy to erythromyocin. The the time of this report, the patient had not yet recovered. The physician assessed the relationship of events to Synvisc as related. On 4/26/2006 pt experienced shortness of breath and went to the emergency room. She received a nebulizer treatment and predisone. At the time of the report, symptoms had not resolved.

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Event Date 6/16/2008

Case description: Spontaneous report on 6/19/2008 by pharmacist re: male pt who had a relevant medical history of osteoarthritis and a recent meniscus repair. The pt received synvisc injections in his rt knee on unspecified dates. After Synvisc injections, the pt experienced fever, chills, shakes and sweating for an unknown period of time. He was admitted to the hospital on the event date due to symptoms, where he was evaluated by infectious disease. Outcome unknown. Pharmacist relates symptoms to Synvisc as possible.

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Event Date: 11/28/2007

All severe in intensity--Left leg jumped, back arched with spasms, whole body muscle spasm. Prickling sensation. Numbing sensation. Itching over total body from scalp to toes.
Case description: spontaneous report received on 12/12/2007 re: male pt who received his first dose of Synvisc. Pt received cortisone pack for 2 months and darvocet with no relief. At date of receipt of report, patients outcome is unknown...Company assessed the following as possibly related to Synvisc: Leg jump, severe back spasms, whole body spasm, prickling sensation, numbing sensation, and itching.

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Event date: 7/10/2007

Knee pain, knee swelling, knee effusion, skin reactions, lower leg cramps, redness and flushing, headaches, feeling tired, moody, knee joint is weak, skin around knee is inf lammed, facial swelling, burning eyes, upset stomach, digestive problem. Info received from male pt, with a med history of osteoarthritis in knees...since first injection, the pt experienced pain, swelling, effusion in both knees. Knees had to be drained 7-8 times. In addition, the pt experienced skin reactions, lower leg cramps, flushing and redness that increased b/t 4 and 6pm. He also had facial swelling, burning eyes, headaches, felt tired, was moody, and his knee jt area was weak. The skin around the knee was inflamed and had upset stomach with digestive problems. At the time of this report the pt had not yet recovered.

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How do you know that you'll not be one of these people?? None of us thought it could happen to us...or we would not have taken the injections of Synvisc.