FDA Adverse Event/Side-Effect Reports -- 9

Lot Number Y0806
Event Date 09/29/2009
Event Type Injury Patient Outcome Life Threatening;
Event Description
Acute circulatory dysfunction [shock], circulatory dystonia [dystonia], hypotony [hypotonia], slight tachycardia [tachycardia]. Case description: spontaneous report received in 2009 from physician regarding a female patient with medical history gonarthrosis. The patient received her first injection of synvisc the month prior, administered via intra-articular route at a dose of 2 ml. The same day, the patient presented at the physician for injection of synvisc in the left knee. Injection was carried out slowly with sterile precautions after disinfection, using sterile gloves and breathing mask. Aspiration of bloody aspirate was noted when turning the injection needle 180 degrees after an unremarkable puncture of the left knee. Subsequent to the injection, the mobility of the knee was free. Approximately 5 minutes after the synvisc injection, the patient experienced acute circulatory dysfunction, hypotony and circulatory dystonia. The patient did not loose consciousness and was oriented to time and place during the events. The patient was placed in a shock position and 100mg prednisolone was administered after providing an access point and preceding oxygen application at 98-99% o2-saturation of the blood. The patient received 500 ml ringer's lactate intravenously, and additional oral glucose and fluid. At an unknown time relative to the events, vital signs were noted to range as follows from the time of 9:12 am to 9:54 am: bp 110/90 to 120/90 mmhg; pulse 68-86 bpm; o2 saturation 98-100%. Within 10 minutes, the patient reached the state of well being. The skin and pupil conditions were back to normal and the slight tachycardia (up to 88 beats per minute) reverted back to a normal results (72-78 beats per minute) after 15 minutes. The physician assessed the event as moderate in intensity and definitely related to the use of synvisc. The product was temporarily interrupted. The patient had recovered the following day. Manufacturer's comment: the benefit-risk relationship of synvisc is not affected by this report.


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Event Date 03/31/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Injection site hematoma [injection site haematoma]. Thrombosis of the vena femoralis left side [thrombosis]. Case description: spontaneous report received on 24-aug-2009 from a healthcare professional regarding a male patient with osteoarthritis, with unknown medical history. The patient received his first does of synvisc administered once via intra-articular route on an unspecified date at a dose of 2 ml. Five days after starting synvisc, the patient experienced haematoma at the site of the synvisc injection. The patient was later diagnosed with deep vein thrombosis. Both events were described by the hcp as moderate in intensity and non-serious. The patient recovered without sequelae afterwards. The hcp assessed the relationship between the events and synvisc as possible. On september 23, 2009, the investigation summary was received. The product lot number was not provided; therefore, a batch record review is not possible. It is the requirement to review all finished batch records for specification conformance prior to release. Any specification result is identified and mitigated. Data is periodically presented and reviewed by individuals responsible for assuring product quality. This review has not indicated trends that could be associated with any product complaint. Genzyme will continue to monitor complaints. Follow up information was received on october 6th from the physician regarding a male patient. The patient's medical history includes coxarthrosis. In 2009, the patient received the first and the second synvisc injection administrated via intra-articular route at a dose of 2 ml one week apart. Five days after the last synvisc injection, he experienced hematoma groin left and thrombosis of the left vena femoralis which required 8 days of hospitalization. The third synvisc injection was temporarily interrupted a week later. No recanalization of the distal vena femoralis was noticed 9 months after the event. As of the date of receipt of this report, the patient recovered with sequelae, the physician reported that he might have possible post thrombosis syndrome. The hcp assessed the intensity of the reported events as severe and possibly related to synvisc treatment. The initial report indicated that the synvisc injections were performed to the hip. Manufacturer's comment: the benefit-risk relationship of synvisc is not affected by this report.

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Lot Number P0902
Event Date 09/18/2009
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Evaluation summary: the production and quality control documentation for lot number p0902, expiry date 10/2011 were reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted.


Event Description
Fluid build-up in left knee [joint effusion]. Swelling in left knee and ankle [joint swelling]. Pain and tenderness in left knee [arthralgia]. Swelling in left foot [oedema peripheral]. Case description: spontaneous report received on 30-sep-2009 from a physician via a company representative, as well as from the consumer, regarding a female pt, whose relevant medical history included: osteoarthritis, knee pain, and previous treatment with supartz followed by knee pain. The pt received a series of synvisc injections, lot number p0902 with expiration date oct-2011, into the left knee with injections received three times within two months in 2009. The pt did not have any problems following the first and second injections. Following the third injection, the pt experienced severe left knee pain and tenderness, severe left knee swelling, and fluid build-up in the left knee. On the following day, the pt went to the emergency room where 80 cc of "yellowish" fluid was withdrawn from the left knee. According to the pt, the physicians in the emergency room did not think that she had an infection in the left knee, so no antibiotics were prescribed. The pt also started to experience some swelling in her left ankle and foot. As of the date of the report, eleven days later, the pt's symptoms in the left knee, ankle, and foot were a little better, but she was still experiencing significant pain, tenderness, and swelling in the left knee as well as swelling in the left ankle and foot. The swelling in the left knee was especially noticeable above the left knee cap. As of the date of receipt of this report, the pt outcome was not yet recovered. The qa (quality assurance) investigation results were received on 07-oct-2009. The production and quality control documentation for lot number p0902, expiry date 10/2011 were reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report.

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Event Date 09/11/2009
Event Type Injury Patient Outcome Other;
Event Description
Swelling in right and left knees and feet, also extreme pain in legs with a fever of 103. Md will not be injecting next scheduled injections for this pt due to side effects. Dose or amount: 2ml, frequency: weekly x3 weeks, route: intra-articular. Dates of use: 2005 - 2009. Diagnosis or reason for use: osteoarthritis.