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.


***
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.

***
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.

***

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.


***

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.


***

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.

***

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.

Sunday, October 11, 2009

The Knee Geek/Guru Site

A friend of this blog contacted me last week. The The Knee Geeks/Guru forum deleted their profile, which resulted in the removal of their posts. This came without a warning, yet accused them of being "flagrantly commercial" for suggesting nontoxic solutions to pharmaceutical viscosupplementations. This poster first sought help from The Knee Geeks/Guru forum immediately following a life-threatening reaction to Synvisc. There they discovered that they were not alone. Their posts progressively turned into the solutions they'd found to help improve their health and other options for joint problems that worked for them, and others they know...including me. The Knee Guru's apparent tolerance for posters who approve of Synvisc or other viscosupplementations in a repetitious manner leads one to speculate whether they singled this poster out. Yet their "site ethos" states:

"Site ethos - this site is run by a medical professional, and professional standards apply.
Although the content may be couched in lay terminology as far as possible, the material is sufficiently educational to be relevant even to medical professionals themselves.
There is no skew of content due to pressure from sponsors. Every attempt is made to be honest with opinions."


If this is true, then why delete a profile from someone who truly suffered and offered their solution to those who have suffered, might suffer or will suffer?

The Knee Guru also site claims:

Funding - currently the site has no direct commercial sponsors. The site is owned by ftmg Associates Ltd. The site has a key philanthropist who wishes to remain anonymous, and who has a special interest in building the KNEEguru into a quality information resource for patients. We hope in time to attract academic funding from offering the site with its vibrant bulletin board as a fieldsite for academic study.

Yet the forum is surrounded by advertisers, including those promoting Synvisc/Synvisc One--hidden behind "OA Knee Pain Treatment--one injection gets up to 6 month..." and many others.

The deletion of this poster's profile also happened within days of disclosing that the FDA no longer allowed the public to read the actual "event descriptions" from patients or health care providers on the MAUDE data base. [Discussed further on Sept 28 post ] Note: this change in public access took place ONLY on the MAUDE site for "medical devices", which is how the FDA classifies Synvisc. [Which is also questionable since it apparently is metabolized and anything injected into the body will cause a chemical change.]

The goal of this blog is to make known the things that people SHOULD KNOW BEFORE they consent to Synvisc. And to let those who reacted and were dismissed by their physician(s) know--YOU ARE NOT ALONE. If I, along with the many others in contact with me had this information PRIOR to our Synvisc injections, our lives would be MUCH healthier today. We are ALL still struggling to return to our "pre-Synvisc" health status...years out from the injections.

Read this blog and MAKE AN INFORMED choice. And be careful who sponsors the clinical trial studies that you believe...follow the money!

Sunday, October 4, 2009

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.

***
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.
.
***
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.
***

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.


***

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.

***

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.

Saturday, October 3, 2009

Are Search Engines Bias??

Out of curiosity and due to some recent events, I decided to try out 4 search engines to see what came up when searching for adverse events/reactions relating to Synvisc injections. Google, Yahoo and Dogpile had the SynviscSurvivor blog either on the first or second page, yet on Bing/Microsoft...it never showed up after 10 pages, so I stopped.

I took it one step further and searched "Synvisc Survivor". Google, Yahoo and Dogpile both had this site as number one, as they should since it's a perfect match. I searched "Synvisc Survivor" on Bing/Mircosoft, and this site NEVER showed up! I searched "Synvisc Survivor Blog", and after 10 pages, I stopped. I even searched the exact web address...and this site didn't show up on it's own. But I did see where others have graciously posted this web address for seeking and hurting people to "get informed", and that's a GOOD thing...at least until someone deletes them, as noticed on popular knee forum full of gurus this past week.

Thank you to those who really care enough about other's health! And thanks for making a REAL difference in the lives of others.

So it seems that where you search for information does matter!

***

Opinions expressed here are strictly that of the poster who suffered tremendously from Synvisc injections. These opinions are not meant to replace medical advice, diagnosis or treatment. Seek a QUALIFIED naturopath for advice and help, or a physician who seeks truth! Never delay or disregard seeking professional medical advice from your physician or other qualified health provider because of something you have read on SynviscSurvivor. SynviscSurvivor does not endorse any specific product, service or treatment, yet will share what helped them if asked privately. If you think you have a medical emergency, call your doctor or dial 911 immediately

Friday, October 2, 2009

Synvisc Not Systemically Absorbed?

I read this Q&A between a potential patient and a physician at this link

http://www.hopkins-arthritis.org/ask-the-expert/treatment-013003/negative-reactions-to-synvisc-571.html.

Information from the physician claims that Synvisc is not systemically absorbed.

According to the following statement with sources, the resident [joint capsule] half-life is days to a few weeks at the most.

Synvisc® may last for a few days (Fiorentini R. , Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/21/96 Fairfax (VA) : CASET Associates, 1996; Berkowitz D., Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/20/96 Fairfax (VA) : CASET Associates, 1996).

My question to those reading this blog:

If Synvisc leaves the joint capsule in that time frame, and doesn't go "systemic" or is "not systemically absorbed" ...

Where does it go? I'd really like to know.