Thursday, July 30, 2009

Divinyl Sulfone is Allowed in Permissible Levels

Divinyl Sulfone

Acute and chronic mammalian toxicity: Sulfur mustard is a vesicant or blistering agent that possesses strong alkylating and consequently demonstrates systemic toxicity in addition to it's effects on skin, eyes and respiratory tract (2). It's also considered a known human carcinogen (59-61). Some HD degradation products retain considerable toxicity including, in some cases, vesicant action. Examples include mustard and hemimustard-TDG aggragates, mustard sulfone and divinyl sulfone. In general compounds that have a 2-chloroethylsulfide moiety are alkylating agents that have vesicant action.

"The Source, Fate and Toxicity of Chemical Warfare Agent Degradation Products Part 2" Article found in Environmental Health Perspectives Vol 107 #12 Dec 1999

Find more information on DVS by googling MSDS Divinyl Sulfone and read the safety sheet.

How is this TOXIC blistering agent "okay" to inject into the human body?

Monday, July 20, 2009

Synvisc Contains Formaldehyde

Synvisc contains formaldehyde in permissible levels, but apparently the FDA does not require Genzyme to disclose that information to the patient. Some may say that formaldehyde's half-life is short, yet before it metabolizes, it can leave a wave of destruction in its wake. And if you are chemically sensitive, even permissible levels of a chemical can be deadly. Don't count on your physician to take your health into consideration before saying, "You're a good candidate for Synvisc injections."

From http://www.chemicalinjury.net/

Formaldhyde activates NMDA. Formaldehyde also stimulates the brain vanilloid receptor. This receptor induces sensitization by activating the NMDA receptor, and increasing nitric oxide, which then increases perioxynitrite, and sets in motion neural sensitization. Vanilloid stimulation also increases the release of immune substance P...which is associated with reactive airway disease.

Explore this site and Chemical Injury.net to find out more. Also read more about permissible levels at http://ciin.org/pages/03-mcs.html

Trust me, the end result is NOT WORTH THE INJECTION.

Wednesday, July 15, 2009

A Synvisc Warning of a Different Kind

Things to consider if a third party insurance is paying for your Synvisc Injections, such as Worker's Compensation, Auto Insurance, Property Insurance, etc.


If you have an adverse reaction to this injection, the situation could get sticky.


One, the physician that you trusted to inject you could EASILY deny your adverse event because they are covering their own interests and possible ties to the company. [Hence the need for the Physician Payment Sunshine Act 2009 to pass!!! Contact your senator http://www.senate.gov/ ] The insurance company will JUMP at the chance to NOT pay for what could be a long lasting health issue...and very costly. None of the above will likely be invested in YOUR best interest, only their own. [unless you're really LUCKY]


Two, the insurance company will jump at ANY chance to NOT pay, even if your reaction fits the possible adverse reactions listed on Genzyme's information sheet for Synvisc. They will fight you, and unfortunately, most physicians you might be referred to don't have the balls to stand up for the patient or the TRUTH. The odds are in favor that the medical community will side with the pharmaceutical company. Odds are that they will say that you suffer from a psycological issue, or will cover it up by saying it's related to a pre-existing condition or another prescription you're taking, or that your adverse event is not related to the Synvisc injections.


Some of the above has happened to ME, and All of the above has happened to many others who have contacted me regarding their experience with Synvisc.


Do you get it?? You WILL be on your own!!!!


Again, Why take the risk?

????

Monday, July 13, 2009

Synvisc Side-Effect reported to forum

This was reported to Knee 1 Forum by a poster named David on 2/02/2002 http://www.knee1.com/forum/messageview.cfm?catid=27&threadid=301&enterthread=y

A warning about Synvisc...I just had a very bad experience and found out from some of the top orthopedist that it isn't that rare. Read on, I am 48 and have moderate to severe arthritis in my left knee (after ACL replacement) which is painful, but manageable and still allows me to participate in active sports like tennis and skiing. A year ago I had Hyalgan injections, which had no side-effects, and gave excellent relief for about 4 months. In preparation for a ski trip to Aspen this year, I decided to have another series to insure that the knee was as pain free as possible during the week of skiing. But this time I opted for the Synvisc version...big mistake. The first 2 injections were fine and the knee was better than ever. However, 2 days after my 3rd injection while I was on my way to my ski vacation to Aspen, my knee swelled to the size of a cantaloupe and was very painful. The clinic in Aspen, after they drained almost a liter of fluid from my knee, told me that they saw this kind of reaction to Synisc in up to 1/3 of their patients...and that they discontinued use a couple of years ago. Now they only use the Hyalgan version, which they've said they've never had a bad reaction to. They say that my knee will recover from the reaction in a couple of weeks...I wish I would've known about the bad track record of Synvisc vs Hyalgan...would've saved me a ski trip. Just wanted to pass along this experience and the word from the Aspen clinic, (and this is knee central due to all of the skiing.) --David
***

I don't know if David's reaction cleared in a couple of weeks or not. If so, he's one of the lucky ones.

Friday, July 10, 2009

FDA Adverse Event / Side-Effect Report 4 -- Synvisc (H-G 20)

Synvisc injections--series of 3 injections in right knee. Could not straighten out knee due to bone spurs. Side-effect--muscle weakness in arms; could not lift arms above shoulders. Pain above shoulders and across back, excruciating spasms in thighs for 45 minutes at a time on 4 nights. Tachycardia on 6 mornings from 5 am to 5:30 am, pain in ribs on right side, aches and pains all over, could not sit in easy chair for more than a half hour at a time, spent most of my time in bed propped up with pillows, very sleepy. Symptoms disappeared all at once 4 weeks after first injection...I could not do much of anything for a month. My orthopedic surgeon said that the reactions I had were not from the Synvisc injections, but after reading about other people's reactions, I'm convinced the Synvisc caused these adverse reactions...

***

Event date 1/13/2006

Shortness of breath, hives and itching all over body, swollen face, swollen eyes, right knee swelling. Report received on 4/12/2006 from a physician via a nurse re: female patient with initials K-P with a history of osteoarthritis...pt began treatment in 12/28/2005. The pt received a series of 3 injections into the rt knee on 12/28/2005, 1/4/2006 and 1/11/2006. The pt experienced hives and itching beginning 2 days after 3rd injection. She was treated with predinosone which helped for about 18 hrs, and then the hives and itching returned. Other antihistamines did not work. On 4/12/2006 her face and eyes were swollen. The pt had not taken any other medications during or after the Synvisc treatment period, except for treatment of the reaction. The patient has no known allergy to chicken products but does have allergy to erythromyocin. The the time of this report, the patient had not yet recovered. The physician assessed the relationship of events to Synvisc as related. On 4/26/2006 pt experienced shortness of breath and went to the emergency room. She received a nebulizer treatment and predisone. At the time of the report, symptoms had not resolved.

***

Event Date 6/16/2008

Case description: Spontaneous report on 6/19/2008 by pharmacist re: male pt who had a relevant medical history of osteoarthritis and a recent meniscus repair. The pt received synvisc injections in his rt knee on unspecified dates. After Synvisc injections, the pt experienced fever, chills, shakes and sweating for an unknown period of time. He was admitted to the hospital on the event date due to symptoms, where he was evaluated by infectious disease. Outcome unknown. Pharmacist relates symptoms to Synvisc as possible.

***
Event Date: 11/28/2007

All severe in intensity--Left leg jumped, back arched with spasms, whole body muscle spasm. Prickling sensation. Numbing sensation. Itching over total body from scalp to toes.
Case description: spontaneous report received on 12/12/2007 re: male pt who received his first dose of Synvisc. Pt received cortisone pack for 2 months and darvocet with no relief. At date of receipt of report, patients outcome is unknown...Company assessed the following as possibly related to Synvisc: Leg jump, severe back spasms, whole body spasm, prickling sensation, numbing sensation, and itching.

***

Event date: 7/10/2007

Knee pain, knee swelling, knee effusion, skin reactions, lower leg cramps, redness and flushing, headaches, feeling tired, moody, knee joint is weak, skin around knee is inf lammed, facial swelling, burning eyes, upset stomach, digestive problem. Info received from male pt, with a med history of osteoarthritis in knees...since first injection, the pt experienced pain, swelling, effusion in both knees. Knees had to be drained 7-8 times. In addition, the pt experienced skin reactions, lower leg cramps, flushing and redness that increased b/t 4 and 6pm. He also had facial swelling, burning eyes, headaches, felt tired, was moody, and his knee jt area was weak. The skin around the knee was inflamed and had upset stomach with digestive problems. At the time of this report the pt had not yet recovered.

***

How do you know that you'll not be one of these people?? None of us thought it could happen to us...or we would not have taken the injections of Synvisc.

Thursday, July 9, 2009

Physicians Payment Sunshine Act 2009 Update

This act would require exposure of financial ties between physicians and pharmaceutical companies, medical supply companies and manufacturer of medical devices. This relationship should be transparent. If you've read this blog, you'll understand why I support the efforts of Sen Charles Grassley to pass the Physicians Payment Sunshine Act 2009.

This has currently reached the Senate Finance Committee which is made up of the following senators. Contact them and support transparency in our health care system. Decisions should be made in the best interest of the patient...not big business and your doctor. This act would expose the ties that could interfere with the best choice for each patient...for YOU.

www.govtrack.us/congress/committee.xpd?id=SSFI

Contact them today.

Monday, July 6, 2009

FDA Adverse Event Report 3 -- Synvisc (H-G 20)

Lot Number 20501

Outcome: Required intervention

Event Description: Synvisc injected into left knee in 2006 over the course of one month, 3 times. Has marked increase in chemical sensitivities, especially to phenols, formaldehyde, and petroleum products. Reacts to print, plastic, gasoline fumes, cosmetics, clothes dryer sheets, etc. Resulting in upper respiratory allergies, increase in muscle and joint pain, cough, and asthmatic type symptoms. Patient confirmed that formaldehyde is used in the preparation of the product and it is not listed on the package label. Synvisc,, 2cc q 1 weekly x 3 intra-articularly.

July 28, 2006
Report date: 2/07/2007

***
Event date: 12/1/2007
Patient outcome: hospitalization
Event Description: Blood clot in right leg. Pain in the ankle and right calf. Swelling in the ankle and right calf. Pain in the knee cap. Synvisc has not worked at all. Information was received on 12/10/2007 from a male patient who had a history of arthritis. The patient received a series of injections in both knees on the following dates: 2 times in the same month, and the following month in 2007. Starting 3 days later he experienced pain and swelling in his right calf and ankle, and in his knee cap. At the time of this report the patient had not yet recovered. Additional info was received on 2/13/2008 from pt. He reported that on 12/12/2007 he was hospitalized for 9 days due to a blood clot in his right leg, which was the same leg he reported as swollen calf. He stated that Synvisc did not work. At the date of this report, the patient had not yet recovered.


****
Patient Outcome: Patient required intervention and required intervention

Event Description: Immune mediated systemic reaction (anaphylactic response), florid rash (rash). Case description received 3/11/2008 from a physician regarding a female patient, initials and age unknown. The patient received a 3 course series of Synvisc, and 2 months later she developed a florid rash and immune mediated systemic reaction. The patient required hospitalization and corticosteroids. The physician reported that the consensus is that it was due to Synvisc as the patient had no other causative factors. They had planned to "i&d" the joint but the patient had a recurrence of her symptoms which prompted emergent hospitalization.
At the date of the report, the patients outcome was unknown.

Synvisc--The Suffering Minority

A forum poster recently said that you only hear from those who had a bad reaction to a drug or medical device on forums and blogs, and that the percentage of those who react are actually small.

There's some truth to what this person posted in regards to many drugs and medical devices, but I often wonder how many of the mysterious conditions today are contributed to the use of prescriptions, and are never connceted. And another troubling thing about their statement...they wrote it in a way to minimize those who seek help for terrible reactions to a drug or medical device. Through my own experience, the medical doctors administering the drug or device are of NO help, especially if it's prolonged or out of the box.

In the case of Synivsc, there's no proven way to extract the gel/liquid from the body or a known remedy in the books. They don't know the systemic half-life of Synvisc, or its metabolic pathway once it leaves the knee joint...thanks to the FDA Medical Device classification, which does not require such. So where can people who suffer find help, advice and know that they are NOT alone?

Most people invested in making money off a product are only concerned about their bottom line...not the good of the patient. [I know that statement is not true for all physicians. However, it is true for all of us who I'm in contact with who reacted to Synvisc. The FDA, Genzyme and our physicians dismissed us, and left us to fend for our own lives. That's the real bottom line you should consider... You're on your on if somethine goes array.]

I wonder if this person would minimize such reactions and reports of reactions if the drug or medical device had destroyed their health, almost killed them, or did the same to someone they love.

So I say to all of you who are suffering from a product the FDA deemed safe, keep reporting!!

How do you know if you're going to be one of the suffering minority or not?

AND do you really want toxic substances to permeate your body and add to your toxic load?

Why take the risk when there are other options without?

Saturday, July 4, 2009

FDA Adverse Event / Side-Effect Report 2 -- Synvisc (H-G 20)

This report is taken from the FDA Maude site where adverse reactions/events are reported.

Event Date 4/23/2009

Report Date 5/15/2009

Swelling in the throat, pain the right leg that went down to the toes, difficulty breathing, swelling of face, dizziness, nausea, rash, headache, injection was painful, passed out twice, chest pains, jaw pain. Spontaneous report.

Case description recieved on 5/15/2009, from a female patient initials c-m whose relavent medical history included a torn ACL replaced in 2000, fell and tore lateral mensicus which was removed, arthritis in the right knee, and previous Synvisc injections in 2008. The patient recieved the 3rd injection of her most recent series of Synvisc injections in her right knee in 2009. The injection was painful and it went down her leg into her toes. Following her injection, patient experienced swelling in her throat and face, chest pains, difficulty breathing, jaw pain, nausea, rash, headache, dizziness, and passed out twice. The patient was hospitalized for 3 days for testing related to above symptoms that were worsening. She had a ct of her throat, swallow study, and numerous other tests which have not shown any particular reason for her symptoms. The symptoms "come and go" and "hit her like a wave". As of date of report, patient's outcome is unknown.

Information extracted from the FDA Maude site for Adverse Reactions to Synvisc (Hylan G-F 20) manufactured by Genzyme.

Whoever you are, you are not alone!!

Friday, July 3, 2009

Increased Reactions / side-effects With Each Synvisc Injection

Note: In an effort to keep the information as accurate as possible on this blog, I've posted links to support the data and some verbatim information. Blogspot has now tagged my blog and will not let me do so. I will suggest searches to help you find the research that backs up my post. Sorry for the inconvience.

Conculsion of one study: This study suggests that it's reasonable to tell patients who've been treated with a course of Hylan G-F 20 [Synvisc] and who want more shots that the likelihood of a painful localized acute reaction to the medical device appears to increase. More studies of the frequency of acute local reactions following repeated injections of Synvisc and study of mechanisms of those reactions are warranted.

The full abstract is found on the NCBI Pub Med gov site. You can google to find "Increased frequency of acute local reactions following repeated course of Hylan G-F 20."

Thursday, July 2, 2009

FDA Adverse Event / Side-Effect Report -- Synvisc (H-G 20)

http://www.accessdata.fda.gov/

The following adverse event / side-effect was reported to the FDA Maude site for Synvisc manufactured by Genzyme.

Event Date: 11/29/2007

Event description: Medwatch, date 12/12/2007, was received by the fda via a corep on 8/26/2008. The report concerned a male who reported muscle spasms, muscle pain, contractions of entire body, suffocation, tingling, itching, and numbness of entire body, neuropathy, hot sweats, redness at injection site, tenderness at injection site, swelling at injection site, systemic reaction attacking nervous system, dizziness, weakness of left side of body, difficulty speaking, difficulty walking and symptoms of stroke after starting Synvisc. The reported of the event is the pt's wife. The patient recieved one injection of Synvisc at unknown site the prevous month at the doctor's office. At the time of injection, the patient experienced a pronounced muscle spasm. One hour later, pt experienced muscle spasms in back, pain and contractions of entire body, and contractions of temporal mandibular joint that caused the patient to suffocate. The pt reported pulling on his beard to release the mandibular joint contraction. He also experienced numbness, tingling, and itching of his entire body as well as hot sweats...On the same day, the pt went to the emergency room where the dr reportedly diagnosed the pt with a systemic reaction attacking the nervous system. The pt reported the reaction the drs. On the following month, the pt was admitted to the hospital with symptoms of stroke, dizziness, weakness to the left side of his body, difficulty speaking, difficulty walking. At the time of report, outcome is unknown.


Whoever you are...YOU are NOT alone.