FDA Adverse Event and Side Effect Reports--7

The FDA has removed the side-effects event descriptions as of Sept 2009 and made it harder for the consumer to make an informed consent. I will continue to share some of the descriptions that I've collected since my life-threatening reaction to Synvisc.

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SYNVISC HYLAN G-F 20
Event Date 09/24/2004
Event Type Injury Patient Outcome Hospitalization;
Event Description
Weakness in legs, paresthesias below navel, inability to control legs, pain in both knees, swelling in both knees, left knee aspirated, pain in both legs, numbness in both legs. Initial information was received in 2004 from a physician regarding a pt, (age and initials unknown), who experienced weakness in the legs. The pt's medical history, indication, therapy dates, concomitant medications and outcome were not reported. The pt received synvisc injections to an unknown site on unknown dates. Sometime after receiving synvisc the pt experienced weakness in the legs which the physician reported was possibly related to a spinal tumor or growth and not related to the synvisc. No further info was provided. At the time of this report, the pt's outcome was unknown. Additional info was received 4 days later from the physician's office. The pt received synvisc in both knees 3 months ago, the following month, and 7 days later. Pt experienced pain in both knees and called the doctor. 3 days later, they reported increased swelling and pain in the knees. The doctor aspirated the left knee and sent the fluid for analysis; the fluid culture was negative. 3 days later, the doctor saw the pt again. 4 days later, pt experienced a sudden onset of paresthesias below the navel and inability to control the legs, and was hospitalized by the primary care physician. Mri results were negative. The duration of the hospitalization was unknown. 22 days later the pt experienced pain and numbness in both legs. The primary care physician thought the pt had a possible reaction to synvisc. At the time of this report, the pt's outcome was unknown.
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Lot Number UINK
Event Date 05/01/2006
Event Type Injury Patient Outcome Hospitalization;
Event Description
Knee pain. Info was received on 5/10/06 from a product mgr, who received the info from a health care professional in regards to a pt initials unk. The pt received two synvisc injections into an unk knee on an unk date. On an unk day after the second injection the pt complained of severe knee pain. There were no systemic reactions. Due to the severity of the pain the pt could not continue the treatment course. The health care professional that administered synvisc was very experienced in performing intra-articular injections and did withdraw fluid before the synvisc injection. No causality assessment was provided. At the time of this report the outcome was unk. Follow-up info was received from a health profession on 7/14/06 in regards to this pt. The pt received two injections of synvisc into the left knee. The first injection was in 2006 and the second five days later. The pt did not receive the third injection. The pt experienced left knee pain, swelling and effusion; dizziness, decreased blood pressure, hand convulsions, and diaphoresis. The pt was hospitalized on an unk date. On two days 30 ml of effusion was removed. The decreased blood pressure was treated with fluid infusion and the hand convulsions were treated with calcium injection. The physician assessed the adverse events as definitely related to synvisc. At the time of this report the pt had recovered.
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SYNVISC INTRA-ARTICULAR HYALURONIC ACID
Event Type Injury Patient Outcome Hospitalization;
Event Description
Angio-edema, rash; skin flushing; shortness of breath; bronchospasm. Information was received on 09-aug-2006 from a physician in another country, regarding a patient of unk sex and age, initials unk, with unk medical history, who experienced angio-edema and a rash. The patient began treatment with synvisc on an unk date. The patient received an unk number of synvisc injections into an unk site on unk dates. The patient developed angio-edema and a rash which lasted approximately 10 days after receiving the synvisc. At the time of this report, the patient's outcome was unk. The physician had not assessed the relationship of the events to synvisc. Additional information was received on 11-sep-2006 from the physician. He provided the patient's initials, date of birth and gender (female). The physician stated that on an unk date, approximately two hours post synvisc injection, the patient developed skin flushing and shortness of breath. No bronchospasm was indentified at that time. After four hours of care, the patient was discharged and then developed more intense shortness of breath with bronchospasm. The patient was admitted to the hospital and required frequent observations to control her symptoms. At the time of this report, the patient's symptoms were ongoing. The physician also stated that this patient had many psychosomatic issues and felt that many of the symptoms were patient subjective. He is uncertain about the relationship between the events and synvisc.


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Lot Number U0601
Event Date 10/24/2006
Event Type Injury Patient Outcome Other; Required Intervention
Event Description
Left lower extremity pain, left lower leg swelling, left knee swelling, left knee inflammation, left knee effusion. Information was received on 31-oct-2006 from a sales representative regarding a male patient (age and initials unk) with an unk medical history, who experienced swelling in the knee, inflammation in the knee and knee effusion. The patient began treatment with synvisc in 2006. The patient received an unk number of synvisc injections in2006. On an unk date, the patient experienced swelling and inflammation in the knee. The time frame in relation to the synvisc injection was unk. The physician aspirated the knee and cultured the aspirate. Cultures were negative, except the white blood cell count was 22,000. At the time of this report, the patient's outcome was unk. Additional information was received on 06 november 2006 from the physician. It was reported that the patient was a male, with a history of moderate osteoarthritis with joint narrowing and osteophytes and prior treatment with non-steroidal anti-inflammatory drugs (nsaids). The patient received synvisc injections in 2006, 7 days later and 5 days later. Two weeks later, the physician aspirated the left knee and injected an unspecified steroid at an unk dose. It was reported that a venous duplex exam was performed by doppler ultrasound to further evaluate left lower extremity pain and swelling. The results of the ultrasound were as follows: normal exam of the left lower extremity deep veins. In october 2006 the synovial fluid lab results were as follows: culture and gram stain were negative for bacteria and white blood cell counts were elevated at 22,250/mm. At the time of this report, the events of left knee swelling, left knee inflammation and left knee effusion were resolving. The physician assessed the relationship of synvisc to the events as probable.

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SYNVISC HYLAN G-F 20
Event Date 09/08/2004
Event Type Injury Patient Outcome Other; Required Intervention
Event Description
Info was received in 2004 from a pt, with a medical history of osteoarthritis who experienced right knee pain to ankle to toes, right knee swelling and can barely walk. The pt had not received prior synvisc injections. The pt began a treatment with synvisc in 2004. On an unknown date the pt began to experience swelling in their right knee and pain that started behind the knee and went down to their ankle and toes. The pain was described as "debiltating. " the pain was worse now then prior to synvisc. The pt could barely walk after trying to get up from lying down. At the time of this report, the pt continued to have pain and swelling. Additional info was received three months later from the physician. The physician reported that the pt has a history of moderate osteoarthritis with x-ray grade iii, joint narrowing and osteophytes. The pt was treated with nsaids and steroids in the past (date unknown). The pt received injections into the right knee in 2004. A week later, following the third injection the pt experienced pain, swelling, effusion and lower leg swelling. Effusion was not collected before any injections. A month later, the pt was treated with intra-articular cortisone injection. The physician assessed the symptoms as injection related. At the time of this report the pt's outcome was unknown. Mfr's comment: synovial fluid or effusion should be removed before each synvisc injection. Qa investigation results: review of data did not indicate trends that could be associated to any product complaint.