Wednesday, November 3, 2010

fda adverse event/ side effects reports - 10

Two doctors that I saw in regards to my life-threatening adverse event DISCREDITED the FDA MAUDE reports because they are "often sent in by the patient." One said that he petitioned the FDA to stop posting such reports unless the physician submitted them. When most physicians who administer Synvisc are in denial of causation, the public would NEVER learn the truth. And WHY do doctors believe that patients do not know their own bodies, and can file such reports?

Here are more reports to the FDA MAUDE database.
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Event Date 01/06/2010
Event Type Injury Patient Outcome Other;
Event Description
I received synvisc injections in both knees on (b)(6)2010, (b)(6)2010 and (b)(6)2010. A few days after the 1st injection, i noticed "pins + needles" and burning sensation on my arms and back, neck + legs. The same dr prescribed prednisone + zyrtec (no relief). I then saw a dermatologist who prescribed a 28 day regimen of prednisone. The condition was relieved but when i stopped the prednisone the condition came right back. It is now almost 9 months after the 1st injection of synvisc and i still have the same uncomfortable painful condition. Dates of use: (b)(6)2010, (b)(6)2010, (b)(6)2010. Diagnosis or reason for use: osteoarthritis. Event abated after use: no.

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Event Date 02/09/2010
Event Type Injury Patient Outcome Required Intervention; Other
Event Description
Letter written 04/05/2010. On (b) (6) 2010, dr. (b) (6) gave me a referral to see dr. (b) (6) at the orthopedic and fracture clinic, (b) (6), to receive possible cortisone shots in both my left and right knees. Dr. (b) (6) was not available so the clinic had me see dr. (b) (6) at the same location. My initial office visit was (b) (6) 2010 with dr. (b) (6). They took x-rays and dr. (b) (6) told me that there was something much better and more effective than cortisone shots called synvisc one and that if i was not allergic to chicken, eggs or any such products that i was a perfect candidate for these injections. My first injection was on (b) (6) 2010, in my right knee. The left knee synvisc one injection was done on (b) (6) 2010. In less than two days, i had terrible pain. My knees were very swollen; i couldn't even walk nor go to work. When i went to my first consultation appointment with dr. (b) (6), i walked in wearing high healed wedged boots and only wanted a cortisone shot. He said he wouldn't give me cortisone shots unless i was going on a trip. The choices he gave me were to either opt for the synvisc one injections or knee replacement surgery. I do not need knee replacement, so i trusted dr. (b) (6) and with his advice chose the synvisc one injections. He said that the affects of these injections were much better than cortisone shots & would last for six months to two years, i was so excited! by (b) (6) 2010, i was so swollen that he had to drain 30 cc of fluid from my right knee and 15 cc of fluid from my left knee. Dr. (b) (6) said they had to culture the fluid to see if i had any infection and to not eat after midnight in case i had to go into the hospital the next morning for emergency surgery. I heard back from (b) (6) his assistant friday morning that i had no infection. Since (b) (6) 2010, i have been walking with a cane and have not been able to drive - my husband has to drive me wherever i go. I also have not been able to work since i had the injections. On (b) (6) 2010, i saw dr. (b) (6) and he admitted at that time that i was the third person as this clinic to have an allergic reaction to synvisc one at their clinic after seeing me & the negative results it had on me. In my opinion, they should not have given these shots to anyone after the first allergic reaction. That same day, he drained fluid from both legs and cultured it again to make sure there were no "bugs" growing, as he put it to me. Also, at 5 pm, that same day, they ordered an appointment for me to go to (b) (6) hospital for an ultrasound on my left leg to rule out any possibility of a blood clot. The results were negative. Thank goodness. On (b) (6) 2010, at 3 pm, i saw dr. (b) (6). He advised me to have knee replacement surgery a. S. A. P. I was walking fine on my first visit on (b) (6) 2010, in high heeled wedge boots. I do not need knee replacement! therefore on (b) (6) 2010, i asked dr. (b) (6), "how long will it take or how does synvisc one leave my body?" no one had an answer for me. That is when i asked if i could have cortisone shots in my knees so that i could have some relief from the pain & affects from the synvisc one shots. After two hours, they finally agreed to give me the cortisone shots, yet very reluctantly. Today, i am still walking with a cane, not working, and my body shakes from these synvisc one injection shots. None of these symptoms did i have prior to receiving these injections. This is totally inexcusable! i feel like i have two broken knee caps. I reported this to synvisc one at their phone number (b) (4) and at www. Synvisc. Com. I have yet to receive a call back from them! i also reported this to the fda to (b) (4). My fda consumer complaint (b) (4). This product in my opinion should not be on the market at all. And how is someone going to fix my problem? the side affects and reactions my body has are from nothing other than the synvisc one injection shots at this clinic. The fda must investigate this synvisc one on my behalf and provide me with all info such as how many pts were injected with synvisc one and the condition of all these pts. I deserve to know what kind of permanent damage was done to me and my body by these synvisc one injection shots. Frequency: injection- each knee. Dates of use: (b) (6) 2010; (b) (6) 2010. Event abated after use, stopped or dose reduced: no.

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Event Date 07/01/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Felt funny [feeling abnormal]. Disoriented [disorientation], right leg pain [pain in extremity], respiratory problems [respiratory disorder]. Right leg swelled up [oedema peripheral]. Case description: a spontaneous report was received on 14-mar-2010 and 16-mar-2010 from a (b) (6) male pt with a history of osteoarthritis of the knee, (b) (6), who experienced feeling funny, right leg swelling, right leg pain, disorientation and respiratory problems after treatment with synvisc. The pt had no history of previous treatment with synvisc. On unspecified dates in (b) (6) 2009, he received treatment with synvisc in the right knee. Soon after getting synvisc, the pt felt funny and disoriented. He also experienced right leg pain and swelling. The disorientation worsened and four days after the onset of symptoms, he was transported to the hosp by ambulance. The pt reported that he spent four days in the intensive care unit where he experienced respiratory problems. At the time of this report, the outcome of the pt was unk. Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report.

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Event Date 02/01/2010
Event Type Injury
Event Description
Complainant has osteoarthritis. She had been receiving cortisone shots every 4-6 months for the last 1 1/2 years with no problems. Her primary care doctor convinced her that the new synvisc one would be the best thing for her, so she agreed to the shots. On (b) (6) 2010, she received an injection of synvisc one in her right knee. On (b) (6) 2010, she received an injection of the same in her left knee. Approx 2 1/2 weeks later on (b) (6) 2010, her legs swelled up and she was in excruciating pain. She was seen by her primary care doctor who withdrew 30 cc of fluid from her right leg and 15 cc of fluid from her left leg. These were later cultured and found to have no infection. She was rushed to (b) (6) hospital, (b) (6) where she had an ultrasound and they determined that she did not have any blood clots. She is not allergic to eggs or poultry products. She is so upset because the doctor admitted to her in the presence of her husband that she was the third person this month at this clinic to have a reaction. She was previously very active and athletic and now can hardly walk. She lays down at 5:00 pm each day and doesn't' get up until noon the following day because she feels so terrible. This severely limits her mobility and affects her employment as well as she is self-employed and cannot get to work. She contacted the company and was told to contact the mfr which is the genzyme corp.

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Event Date 08/01/2010
Event Type Injury Patient Outcome Hospitalization;
Event Description
Increased blood pressure [blood pressure increased]. Flushed in the face [flushing]. Felt dizzy [dizziness]. Headache [headache]. Case description: a spontaneous report was received on august 16, 2010 from a (b)(6) female patient with a history of osteoarthritis, (b)(6), who experienced blood pressure had risen to 168/90, felt flushed in the face, felt dizzy, and headache after treatment with synvisc. The patient had no history of previous treatment with synvisc. On (b)(6) 2010, the patient received an injection of synvisc into her left knee. On (b)(6) 2010, one day after the injection, the patient reported that she felt flushed in the face and dizzy for about 10 seconds. On (b)(6) 2010, the patient received her second synvisc injections. Two days later on (b)(6) 2010, the patient felt dizzy again, "like i was having a stroke" for about 3-4 minutes. She went to the emergency room where she reported her blood pressure had risen to 168/90. She was admitted overnight for testing. Treatment included starting an unspecified blood pressure medication. Mri and ct scans were both negative. Her blood pressure returned to normal, and the patient was discharged on (b)(6) 2010. On (b)(6) 2010, the patient complained of an ongoing headache. She reported that she is following up with her physician and plans to have her third synvisc injection. Manufacturer's comment: the benefit risk relationship of synvisc is not affected by this report.

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Event Date 06/03/2010
Event Type Injury Patient Outcome Hospitalization;
Event Description
Cellulitis of the right leg [cellulitis]; vomiting [vomiting]; right knee redness 3 inches below the right kneecap [erythema]; fever [pyrexia]; nausea [nausea]; right knee swelling [joint swelling]; right knee pain [arthralgia]. Case description: spontaneous report received on 06/07/10 from a (b)(6) female pt, (b)(6), with a relevant medical history of osteoarthritis of both knees and previous synvisc injections about five years ago. The pt received the synvisc-one injection into each knee on (b)(6) 2010. The synvisc-one lot number was unk. On the morning of (b)(6) 2010, the pt woke up with right knee pain, right knee swelling, and right knee redness 3 inches below the right kneecap. The pt also complained of flu-like symptoms including: nausea, vomiting, and fever. Starting on 06/03/10, the pt was hospitalized for the events. The pt was diagnosed with cellulitis of the right leg and treated with keflex and clindamycin. The pt was discharged from the hospital on (b)(6) 2010, at which time the right leg cellulitis was improving. No further info was provided. As of the date of receipt of this report, the pt outcome was unk.

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Event Date 04/18/2010
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
H. Influenzae septic arthritis [septic arthritis haemophilus]. Unable to bear weight [weight bearing difficulty]. Knee hot [joint warmth]. Pain in the left knee [arthralgia]. Knee swollen [joint swelling]. Knee effusion [joint effusion]. Elevated liver enzymes [hepatic enzyme increased]. Case description: regulator-spontaneous report (b)(4) received on 01-jun-2010 from a pharmacist regarding a pt whose initials, age and gender were not provided. The pt had a history of osteoarthritis and pain. The pt received synvisc-one injections in both knees. The lot number of synvisc-one used was not provided. Two days later on (b)(6)-2010, the pt reported to the emergency room complaining of severe pain in the left knee only. The pt was unable to bear weight. The knee was also hot and swollen. Aspiration of the knee revealed h. Influenzae on culture. The pt was admitted to the hospital once the culture results were available. After i&d, the tp was started on intravenous (iv) antibiotics for septic arthritis which included ceftriaxone 2gm every day. It was reported that the pt had elevated liver enzymes. As of the date of receipt of this report, the pt's outcome was unk. Mfr's comment: the benefit-risk relationship of synvisc one is not affected by this report.

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Event Date 03/01/2010
Event Type No Answer Provided Patient Outcome Other;
Event Description
Right leg pain [pain in extremity], difficulty walking [gait disturbance], baker's cyst felt tighter [synovial cyst], knee pain [arthralgia], leg/knee pain back [device ineffective]. Case description: an spontaneous report was received on 02-jun-2010 from a (b)(6), female, patient, with a history of osteoarthritis of the right knee, (b)(6), who experienced intense right leg and knee pain, difficulty walking, her baker's cyst felt tighter, and her right knee pain was back to where it was, before she received the synvisc-one. The patient received an injection of synvisc-one in the right knee in (b)(6) of 2010. The patient reported that after about three days of receiving the synvisc-one injection, she experienced intense right leg/knee pain. The patient also had difficulty walking and complained that the baker's cyst on the back of her right knee felt tighter. According to the patient, she was treated with a dose-pack of prednisone which alleviated her right leg pain. The patient stated that now her leg/knee pain is back to where it was, before she received the synvisc-one injection. At the time of this report, the outcome of the patient was unknown. Manufacturer's comment: the benefit-risk relationship of synvisc one is not affected by this report.


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Lot Number U0912
Event Date 01/20/2010
Event Type No Answer Provided Patient Outcome Other;
Event Description
Knees were red [erythema]. Knees were hot [joint warmth]. Fever [pyrexia]. Knee pain [arthralgia]. Knee effusion [joint effusion]. Knees were swollen [joint swelling]. Normal gait was not possible/needed crutches for walking [gait disturbance]. Case description: a spontaneous report was received on 10-may-2010 from an hcp regarding a (b)(6) male pt with a history of gonarthrosis of the knee (of degenerative etiology), (b)(6), who experienced fever, knees were hot, red and swollen, normal gail was not possible, needed crutches for walking, and knee pain and effusion after starting synvisc. On (b)(6) 2010, an initial report was received from the pt's hcp. The hcp reported that the pt had a history of advanced bilateral gonarthrosis, and prosthesis placement was contra-indicated in the pt. According to the hcp, the pt was treated in both the knees with synvisc. There was no incident after the first set of injections in both the knees. After the second set of injections in both knees, in less than 24 hours, the pt experienced knee pain and effusion. Syringes from two different lots were used for the first and second set of injections. The hcp stated that he planned to switch to euflexxa for the next treatment. On 10-may-2010, additional info was received from the hcp wherein the hcp elaborated on the pt's medical history. He added that the pt had a right meniscus removal in 1970; had surgery for carpal tunnel syndrome (cts) in 2005, and also has benign prostate hyperplasia (bph). The hcp also stated that the pt has had previous treatment with synvisc in the past; 2004, synvisc in the right knee; 2008, synvisc in both knees; 2009, synvisc in both knees. In all these instances there was "no incident" with the usage of synvisc. He also stated that the pt had gonarthrosis of degenerative etiology. The concomitant medications the pt was on were dutasteride for (bph) and chondrosulf (for osteoarthritis). In the 2010 synvisc series, the pt was injected with synvisc on (b)(6) 2010 and (b)(6) 2010 in both knees. No arthrocentesis was performed prior to the synvisc injections. A green, 21 gauge syringe was used for each injection and the synvisc was at room temperature when injected. The syringes used in the first and second set of injections were from a different lot. The lot number for the first set of injections is not known. The syringes used for the second set of injections are from lot number u0912. According to the hcp, in less than 24 hours following the second injection, the pt experienced pain and effusion. The pt also experienced fever, his knees were swollen, hot and red. Normal gait was not possible and the pt needed crutches to walk. Clinical signs were mimicking septic arthritis or hyperuricemic arthritis. The c-reactive protein was elevated at 182 mg/l and the eosinophil sedimentation rate was at "45/84 mm western green. " the pt was treated with icepack and rest. On 12-may-2010, additional info was received in the form of qa results. The production and quality control documentation for lot #u0912, with expiration date, 07/2012 was reviewed. The investigation showed that the product met specifications. No associated non-conformances were noted. On 17-may-2010, additional info was received from the hcp wherein the hcp clarified that this was not a case of septic arthritis or hyperuricaemic arthritis. The hcp stated that the clinical symptoms initially led to the suspicion but the pt quickly recovered without any sequelae. In the opinion of the hcp, the adverse events experienced by the pt were of severe intensity and were definitely related to the use of synvisc. At the time of this report, the pt has recovered without sequelae from all the adverse events. The onset date for the event was (b)(6) 2010 and the offset date was (b)(6) 2010.

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Event Type No Answer Provided Patient Outcome Required Intervention;
Event Description
Extreme pain [arthralgia]. Swelling [joint swelling]. Benign tumor in the back of left knee [benign neoplasm]. Ruptured baker's cyst right knee [synovial rupture]. Osteoarthritis in right knee [osteoarthritis]. Case description: a spontaneous report received on 16-apr-2010 from a (b)(6) female pt, (b)(6), with a medical history of left knee pain and right knee anterior cruciate ligament (acl) replacement in 2006. The pt received the synvisc series into the left knee on unk dates in 2007. On an unk date, a benign tumor was discovered in the back of her left knee which was removed on an unk date. In addition, on an unk date she experienced extreme pain, swelling, and was diagnosed with left knee synovitis. On an unk date in (b)(6) 2010, the pt experienced a ruptured baker's cyst in her right knee. The pt has left knee replacement surgery scheduled for (b)(6) 2010. The outcome of the event of benign tumor was resolved. No lot number was provided. No further info provided. (b)(4). Mfr's comment: the benefit-risk relationship of synvisc is not affected by this report

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Event Date 01/06/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
Patient has been receiving three-dose synvisc for more than a decade without incident. But one day after her first dose of synvisc one -- a new single-dose version -- her mobility has been drastically reduced, the pain pretty much limiting her to bed. Her condition has remained this way for nearly a month. One night, the middle finger of one hand became swollen, sore and hot to the touch. The curvature of her spine has also gotten worse. Dose or amount: don't know any of because i neither doctor nor patient.

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8 comments:

  1. And WHY do doctors believe that patients do not know their own bodies, and can file such reports?

    Because they're arrogant asses who think they're God and everyone else is an idiot.

    Also, money. Always follow the money. There's big money being made by the manufacturer and the doctors peddling this stuff, so both have a vested interest in sweeping the adverse reports under the rug. I hate doctors more all the time.

    I think a good clinical trial for Synvisc would be to require every doctor who wants to use it be personally injected with it first. After all, if s/he doesn't have arthritis it shouldn't hurt, and if s/he does, well, we'll just see how much it helps and what kind of side effects they experience. I guarantee you if it gets personal with the doctors doling this stuff out there will be plenty of action.

    When I think how close I came to getting an injection of this poison last year I feel sick. One of our local news stations did a story a few months ago on the wonders of Synvisc, but there was not one word about the dark side of it. I wrote the reporter who did the story but got no response. (I know, I'm shocked.) Thank you again for this blog. Please keep spreading the word.

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  2. I concur! Thanks for leaving your comment with us.

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  3. Had three Synvisc injections 15 months ago and they worked very well, thought it was a near miracle. Now, the effects have worn off and I embarked on another round of three shots since they worked so well before. This time, I went home after and decided to mow the lawn, that was all. That evening my knee began to swell and despite almost constant icing and 800mg Ibuprophen every six hours, it is still very swollen, I can't walk very well and have been in bed almost constantly since Friday (today is Sunday). My neck feels very tight and I have some shooting pain running down my shoulder/arm to my wrist if I turn my head. That seems to be lessening in the past 6 hours. I am exhausted. Can't understand what might have happened this time. Everything appeared to have been done the same. Calling doc tomorrow a.m.

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  4. Unfortunately, the chance of an adverse event increases with each injection. I would NOT have any more. You run the risk of even further complications like me, three years out! Please return and let us know how you're doing.

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  5. I had synvisc injections and had my last round 2 weeks ago. the horrible swelling has gone down and I have been taken off bed rest, but I can not even put pressure on my knee. I have constant shooting pains in my leg. I used to be able to walk around just fine with mild knee pain, and now I am on crutches. The doc just keeps telling me to "wait it out" because I won't see benefits for about a month after the injections are given. I also sweat more than usual. Is this normal??!??!!!! I'm really freaked out.

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  6. The Romer Family! Sorry for the delay, How are you doing now??

    I would bet that your excess sweat is due to detox.

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  7. I had a synvisc one shot a week ago, I have rash around my eyes, mouth..feels like a third degree sunburn. Within two more days,stomach cramps,diarrea,chills, muscle aches, now trembling inside my body and shooting pains down my left leg in the front of my knee. I have constant stomach pain and am finding it hard to eat. Today blood when I had a trip to the bathroom.
    I am scared! I called the doctor,it took them two days to respond, and they were no help. I am feeling like I have been poisioned. Is there something I can do to detox and slow down the effects of the synvisc ?
    I am traveling and will not be able to return home for another 5 days.
    I am 50 hrs old and a veteran of bumps and bruises. My knee was injured as a preteen playing sports. I have had multiple sugeries on both knees. Nothing has prepared me for this.....

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  8. Find a physician who gives IV Chelation with Vit C AND Meyers Cocktail. It was a LONG 3.5 years for me to restore my health. It's possible, but can be a LONG and expensive journey. If you can't find someone, use Chelation suppositories, homeopathic detoxers, lyposomal Vit C, organic coffee enemas... they will ALL help to rid your body of this LEGAL POISON!!!

    ALSO, if you can find a doctor who uses Ozone to injected into the joints, that will help to restore the joint! AMAZING stuff!!! It also helps to detox the joint.

    I HATE that this product is still on the market!!! The FDA and med docs who make BILLIONS combined are more concerned about their bottom line than an individual's health.

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