Friday, October 16, 2009

FDA Adverse Event and Side Effect Reports--8

The FDA now shows the actual event descriptions / side-effects that a patient or physician sends into them for Aug and Sept '09 and blocks of random date segments. This blog wonders why there is an inconsistency in these database reports? I will continue to keep an eye on this and report what is found.

Here are some reports to the FDA for side-effects/adverse reactions to Synvisc / Synvisc One Read and make an informed consent.:


Event Date 04/01/2003
Event Type Injury Patient Outcome Required Intervention;
Event Description
Nerve inflammation. Information was received on 30 and 31-jul-2003 from a patient, with a history of osteoarthritis, depression and sleep problems. The patient reported they had no known allergies to chicken parts or proteins. The patient received three injections of their first series of synvisc to both knees in 2003. The patient experienced an itching sensation from above the knees, up to and including their private areas and a constant burning feeling that pt described as the skin feeling numb and dead and sharp needles going into their legs and into their private area. The patient also experienced painful sexual intercourse. The patient was referred to a neurologist who conducted nerve analysis and needle tests, which showed that they had nerve inflammation. The patient stated that the physician told pt the nerve inflammation must be due to the synsvic because of the timing, but he was stumped as to why synvisc would cause this. The patient treated the symptoms with benadryl cream, which had no response, and gold bond, which provided some relief. The patient has also taken steroids (type and dose regimen unknown) to help with the burning. 2 months later, the patient was prescribed neurontin (300mg bid), prednisone (10mg bid) and tylox (every four hours). The patient reported that none of the medications helped. 29 days later, the patient consulted their family physician for treatment. The prednisone and tylox were continued, and the neurontin dose was increased (600mg bid). The patient also received duragesic patches (25mg apply every 3 days, for 2 weeks). The new medication regimen did not help. At the time of this report, the patient has not yet recovered. Qa evaluation results: the review of synvisc product release data did not indicate trends that could be associated to any product complaints.


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Event Date 08/04/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Difficulty breathing [dyspnoea], increased blood pressure [blood pressure increased], fainted [syncope], felt like she might faint when standing up [presyncope], lip swelling [lip swelling], chills [chills], dizziness [dizziness], facial rash [rash], hives [urticaria]. Case description: spontaneous report received in 2009 from a female pt whose relevant medical history included: osteoarthritis. The pt received a single injection of synvisc-one into her left knee two days prior. Within 5 to 10 minutes or receiving the synvisc-one injection, she experienced chills, facial rash, hives, dizziness, lip swelling, increased blood pressure, difficulty breathing, and she also fainted. Paramedics were called and took the pt to the hospital, and the pt was admitted that same afternoon. She was treated with saline infusion, antihistamine, and an unk parenteral medication for the treatment of high blood pressure. The pt stated that she might have received another unk medication as treatment. All of her adverse events have improved and the pt has only fainted the single time in the doctor's office. However, the pt reported still feeling like she might faint when she stands up. No further info was provided. As of the date of receipt of this report, the overall pt's outcome was unk.

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SYNVISC

Patient Outcome Hospitalization;
Event Description
Had first synvisc injection into left knee approximately 2:00 p. M. In 2008, in orthopedic surgeon's office by the surgeon. Am status/post left knee arthroscopy in approx four months earlier. Had synvisc at suggestion of physical therapist for ongoing pain issues. I am not allergic to poultry protein, eggs or feathers. Had injection in what i would deem a sterile manner. About 3-4 minutes after injection felt mild tightness in my throat. I was still in physician's office and should have said something but because i was counseled before injection by surgeon that there were no allergic side effects unless i was allergic to poultry protein, feathers or eggs, which i am not and so i had not risk. I honestly was not sure why my throat felt a little tight, but it was mild and i felt i would be ok, not to mention the surgeon said, it was free from side effects except for those previously mentioned. I walked from doctor's office to car and while awaiting my turn to pay my parking fee, felt increased tightness in throat, had some airway difficulty and felt some tightness in upper chest, just below my throat. This was now about 15 minutes after injection. Got out of line and went back to hosp. Made it to the lobby of the physician's office and was awaiting the elevator but by now was having more difficulty getting a deep breath. A passing physician saw me in respiratory distress, got me a wheelchair and called my surgeon who said it to go to er, and i was wheeled to er. Had albuterol nebulizer treatment, iv push benadryl, and iv mini bag decadron. Over the course of about 90 minutes, i felt relief of airway constriction and chest tightness was relieved in full. I was discharged home in about 3 hours time. Emergency room physician called my surgeon who told him it was "impossible i had an allergic reaction because that just doesn't happen unless i was allergic to poultry proteins, eggs or feathers. " emergency room physician told me i indeed did have an allergic reaction and i am a nurse and am allergic to compazine and recognized the same symptoms when i took that medication some years ago being similar to how i felt after the synvisc injection, just less pronounced, a few minutes after i had the first synvisc injection. Have canceled the other two injections. Am disappointed my orthopaedic surgeon is taking this in such a cavalier manner. Being a nurse involved in research for the county department of health, i wanted to follow-up. I found several sites on an internet search identifying infrequent but known respiratory reactions to synvisc injections. I am therefore, following through to the fda in the hopes this report will perhaps enhance the drug warnings and hopefully help another potential pt. Frequency: once, route: im. Dates of use: 2008. Diagnosis or reason for use: left knee pain status/post, left knee arthroscopy. Event abated after use stopped or dose reduced? yes.

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Lot Number UNKNOWN
Event Date 09/13/2009
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Bilateral knee synovitis [synovitis] soreness in one knee after first injection [arthralgia]. Case description: spontaneous report received in 2009 from a physician regarding a female patient, whose relevant medical history included: osteoarthritis. The patient received her first injection of synvisc into both knees in 2009, after which she experienced a "bit" of pain (soreness) in one knee. The synvisc lot number was not available. The patient received her second synvisc injection into both knees five days later, from which she experienced no problems. The patient received the third synvisc injection into both knees the following month. Starting three days later, the patient experienced some stiffness in both knees. She informed the physician that she probably "overdid things" and was "overly active". The following day, the patient started having more pain in her knees along with the swelling and numbness in her leg from the knees down. The patient stated that she could not feel anything from the knees down, resulting in the inability to walk. The next day, she went to her family physician complaining of the inability to walk. In the same month, the numbness from the knees down and the inability to walk was ongoing. Additional information was received from the physician on 22-sep-2009. The patient was seen in the er (emergency room) a week prior with the complaint of the inability to walk, from which the emergency room note was provided. The patient could not feel her legs from her knees down and could not move her legs. She had only pain localized to her knees. She was able to flex her right toes slightly plantar flexed, but that was the only movement she would give. She again stated that she had no feeling from the knees down. She would not straighten her knees at first, but following encouragement from the physician, she was able to fully extend her knees. She did have bilateral knee effusions. She had a good dorsalis pedis and posterior tibial pulse in both feet. She also had a good capillary refill. After sterile prep and anesthesia of the right knee, the knee was aspirated of 40cc of clear, serous fluid, which was sent for lab analysis. After sterile prep and anesthesia of the left knee, the knee was aspirated of 60cc of clear, serous fluid. Following these procedures, the patient was able to move her feet again and felt better and started having feeling return to her feet. The physician's impression was "bilateral knee synovitis", for which he treated her with cortisone injections of "8 and 8". She was recommended to take ibuprofen for pain and to ice her knees. She was also recommended to have limited activity until her knees settled down and felt better. She was allowed to do heel slides and leg lifts. The patient was to call the physician in 2 days for follow-up and then to see the physician in the office the following week if she continued to have pain and problems. The lab results were expected to return on (17-sep-2009). The physician noted that there was no evidence of any infection in either knee at the time of her aspiration. The patient was discharged from the hospital on the day of report. No further information was provided. As of the date of receipt of this report, the patient's outcome was unknown. Manufacturer's comment: the benefit-risk relationship of synvisc is not affected by this report.


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Event Date 08/12/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Deep vein thrombosis [deep vein thrombosis]. Leg stiffness [musculoskeletal stiffness]. Leg swelling [oedema peripheral]. Case description: spontaneous report received on 04-sep-2009 from a physician, and a pt regarding a female pt. The pt initiated a series of synvisc injections into the left knee approx two months prior, at a dose of 3x2 ml given in an interval of one week apart administered via intra-articular route. The pt relevant medical history included osteoarthritis, thyroid gland insufficiency and prior synvisc therapy (2007) without incident. The pt was in good general state of health. The pt received three synvisc injections into the left knee, the first injection being administered together with diprostene (1 ml, betamethasone dipropionate, sodium phosphate) the same day, the second six days later, and the last the following month. Six days later, following the last synvisc injection, the pt experienced left leg stiffness and swelling. The next day, the pt consulted her rheumatologist who decided to inject diprostene (betamethasone dipropionate, sodium phosphate) again. The following day, the pt saw her general practitioner. The general practitioner prescribed her ultrasound-doppler examination of inferior limbs. The ultrasound-doppler examination of the left inferior limb indicated thrombosis of iliacal vein, femoralis, communis, superficialis and profundi, thrombosis of popliteal vein and vena saphena magna from mid-thigh up to the angle. Vena cava was free of thrombi. Thrombosis was fresh and with a mild ultrasound signal. Conclusion was that a large extensive left sided deep vein thrombosis of popliteal, femoral and iliacal veins were found. The event of deep vein thrombosis was unk in intensity. The examination of right inferior limb was normal and with no thrombosis. The pt was hospitalized the same day, to clear the etiology of thrombosis. The pt was treated immediately with fondaparinux (7. 5 mg/6 ml). The pt had recovered and was discharged eight days later. The etiologic research was negative. The physician did not provide the relationship between the event of deep vein thrombosis and synvisc therapy. Investigation summary was received on 09-sep-2009: 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. Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report.


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Event Date 08/04/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
In 2009, 10:30 a. M. , i saw my orthopedic physician in his office. He did an x-ray of my knees and recommended an injection of synvisc-one for my left knee. I had never had this med before and asked about side effects. The doctor told me no side effects except possible infection at the injection site. The doctor gave me an injections of synvisc-one at 11:00 a. M. And told me i could go home. I only walked a few steps down the office hall before i began to have the following side effects: dizziness, weakness, nausea, blurred vision, and trouble breathing. A pt in the waiting area saw my condition and called for the nurse. The nurse told me to sit down, that i was very pale, and was about to faint. The nurse took my vital signs and called emt. I was having chills, a facial rash, and shaking. I was taken by emt in an ambulance to the hosp and treated for an anaphylactic reaction. I was then discharged, but unable to drive home because of still having some side effects. Someone else brought me home. I continued to have these same side effects for seven days. Before this event, i had driven myself to the doctor's office, felt well, and was preparing for the beginning of school. Dose: 48mg in left knee. Frequency: once. Route: injection. Dates of use: 2009 single dose. Diagnosis: osteoarthritis. Event abated after use stopped: no.

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Event Date 01/01/2007
Event Type Death Patient Outcome Death; Hospitalization Required Intervention
Event Description
Death nos [death]. Could not move body/had to lie flat in bed [immobile]. Removal of fluid from right knee [aspiration joint]. Swelling in the right knee/swelled to two times its size [joint swelling]. Case description: spontaneous report received on 12-dec-2007 from consumer regarding a male knee pain pt. The pt has a medical history of knee pain, kidney disease with dialysis and heart problems. The pt received his first dose of synvisc in 2007 administered via intra-articular route at a dose of 2ml in both knees. On an unk number of days after starting synvisc, the pt experienced swelling in the right knee/swelled to two times its size, could not move body/had to lie flat in bed, removal of fluid from right knee, and death. Synvisc was last administered prior to the reported event(s) eight months later. On an unk date, the pt was hospitalized, had a knee washout performed in the right knee and had "other unspecified treatments. " six months later, the pt died from an unk cause of death. As of the date of receipt of this report the pt outcome was dead. No concomitant medications reported. The company assessed the relationship between could not move body/had to lie flat in bed, removal of fluid from right knee, washout of the right knee as possibly related to synvisc. The company assessed the relationship between death as unlikely related to synvisc.

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