Synvisc Hylan G-F 20 offers an updated patient information sheet at http://www.synviscone.com/~/media/Files/SynviscOne/synvisc-patient-information.pdf
Note that Genzyme no longer lists ANY ingredients to let the patient know what is injected into their body.
The following is a list ingredients in each syringe of Synvisc from less than a year ago:
Hylan Polymers (Hylan A & Hylan B) 16 mg
Sodium Chloride 17 mg
Disodium Hydrogen Phosphate 0.32 mg
Sodium Dihydrogen Phosphate Monohydrate 0.08 mg
Water for injection q.s to 2.0 mL
Not mentioned on any patient information sheet to date is the following:
Hylan A is the liquid created when cross-linked withformaldehyde, and Hylan B is the gel created when HA is cross-linked with Divinyl Sulfone to increase the molecular mass. These chemicals can cause neurological damage.
My question: Can anyone tell me why did Genzyme removed the ingredients from the patient information sheet? What does the FDA require?
Monday, June 22, 2009
Saturday, June 20, 2009
Medical Journal Studies on Adverse Reactions / Side-Effects of Synvisc
Here are quotes from research that appeared in peer-reviewed medical journals.
Department of Orthopaedic Surgery, Louisiana State University Health Sciences Center, Shreveport, LA 71130-3932, USA.
The flare reaction after treatment with Synvisc probably is not a Type-1 (antibody-mediated) hypersensitivity reaction, but may be a Type-4 (cell-mediated) hypersensitivity reaction.
http://ortho.sh.lsuhsc.edu/Faculty/Marino/Papers/139CORR2006.pdf.
[Hypersensitivity reactions are typical when the causative agent is a synthetic chemical]
Moreover, some of these drugs based on chemically modified HA, such as Synvisc®, have been involved in reports of sometimes serious adverse events (Hammesfahr JF. et al . , The American Journal of Orthopaedics, 2003, 32:277-283), probably following' the onset of inflammatory processes, especially linked with eosinophil recruitment (Schiavinato A. et al . , Clinical and Experimental Rheumatology, 2002, 20:445-454). Considering the above, new chemical derivatives of HA are being studied that enable the problems linked with both residence time in the joint cavity and the risk of toxicity due to solvents and/or particular chemical agents used in the chemical modification of HA [Synvisc] to be overcome, while maintaining all the characteristics and intrinsic properties of the polysaccharide, unaltered.
From this site http://www.ejbjs.org/cgi/content/extract/85/10/2050
"...Increased Frequency of Acute Local Reaction to Intra-Articular Hylan GF-20 (Synvisc) in Patients Receiving More Than One Course of Treatment" (2002;84:1619-23), by Leopold et al., ... We have seen about 25 similar reactions to hylan G-F 20 [Synvisc] but have not seen such reactions to the naturally extracted sodium hyaluronate, suggesting these adverse reactions are not a hyaluronan class effect. Reactions (painful effusion with cellular infiltrate and negative culture) occurred within 24 hours after an injection, presented in the second series of injections or later, and generally required intervention. Some cases improved within days after intra-articular injection, while others were more prolonged. [Full Text of this Article]
J Rheumatol. 1996 May;23(5):944-5; author reply 946. J Rheumatol. 1996 May;23(5):945-6.
Acute local reactions after intraarticular hylan for osteoarthritis of the knee.
Puttick MP, Wade JP, Chalmers A, Connell DG, Rangno KK.
Department of Medicine, University of British Columbia, Vancouver, Canada.
OBJECTIVE. To describe acute local reactions following intraarticular hylan injection and determine their frequency. .. RESULTS. Twenty-two patients had 88 injections to 28 knees. Six patients had reactions within 24 h of injection characterized by pain, warmth, and swelling, lasting up to 3 weeks. This occurrence was unpredictable. Corticosteroid injections were sometimes required. .... CONCLUSION. Intraarticular hylan [Synvisc] was associated with significant local inflammatory reactions in 27% of patients, or 11% of injections. The mechanism(s) and long term sequelae are unclear.
PMID: 7562764 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/18050181?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
Arthritis Rheum. 2007 Dec 15;57(8):1410-8.
Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis.
Reichenbach S, Blank S, Rutjes AW, Shang A, King EA, Dieppe PA, Jüni P, Trelle S.
University of Berne, Berne, Switzerland.
OBJECTIVE: To compare the effectiveness and safety of intraarticular high-molecular hylan with standard preparations of hyaluronic acids in osteoarthritis of the knee. ... CONCLUSION: Given the likely lack of a superior effectiveness of hylan [Synvisc] over hyaluronic acids and the increased risk of local adverse events associated with hylan [Synvisc], we discourage the use of intraarticular hylan [Synvisc] in patients with knee osteoarthritis in clinical research or practice.
PMID: 18050181 [PubMed - indexed for MEDLINE]
[http://www.wipo.int/pctdb/en/wo.jsp?wo=2006092233&IA=WO2006092233&DISPLAY=DESC ]
Department of Orthopaedic Surgery, Louisiana State University Health Sciences Center, Shreveport, LA 71130-3932, USA.
The flare reaction after treatment with Synvisc probably is not a Type-1 (antibody-mediated) hypersensitivity reaction, but may be a Type-4 (cell-mediated) hypersensitivity reaction.
http://ortho.sh.lsuhsc.edu/Faculty/Marino/Papers/139CORR2006.pdf.
[Hypersensitivity reactions are typical when the causative agent is a synthetic chemical]
Moreover, some of these drugs based on chemically modified HA, such as Synvisc®, have been involved in reports of sometimes serious adverse events (Hammesfahr JF. et al . , The American Journal of Orthopaedics, 2003, 32:277-283), probably following' the onset of inflammatory processes, especially linked with eosinophil recruitment (Schiavinato A. et al . , Clinical and Experimental Rheumatology, 2002, 20:445-454). Considering the above, new chemical derivatives of HA are being studied that enable the problems linked with both residence time in the joint cavity and the risk of toxicity due to solvents and/or particular chemical agents used in the chemical modification of HA [Synvisc] to be overcome, while maintaining all the characteristics and intrinsic properties of the polysaccharide, unaltered.
From this site http://www.ejbjs.org/cgi/content/extract/85/10/2050
"...Increased Frequency of Acute Local Reaction to Intra-Articular Hylan GF-20 (Synvisc) in Patients Receiving More Than One Course of Treatment" (2002;84:1619-23), by Leopold et al., ... We have seen about 25 similar reactions to hylan G-F 20 [Synvisc] but have not seen such reactions to the naturally extracted sodium hyaluronate, suggesting these adverse reactions are not a hyaluronan class effect. Reactions (painful effusion with cellular infiltrate and negative culture) occurred within 24 hours after an injection, presented in the second series of injections or later, and generally required intervention. Some cases improved within days after intra-articular injection, while others were more prolonged. [Full Text of this Article]
J Rheumatol. 1996 May;23(5):944-5; author reply 946. J Rheumatol. 1996 May;23(5):945-6.
Acute local reactions after intraarticular hylan for osteoarthritis of the knee.
Puttick MP, Wade JP, Chalmers A, Connell DG, Rangno KK.
Department of Medicine, University of British Columbia, Vancouver, Canada.
OBJECTIVE. To describe acute local reactions following intraarticular hylan injection and determine their frequency. .. RESULTS. Twenty-two patients had 88 injections to 28 knees. Six patients had reactions within 24 h of injection characterized by pain, warmth, and swelling, lasting up to 3 weeks. This occurrence was unpredictable. Corticosteroid injections were sometimes required. .... CONCLUSION. Intraarticular hylan [Synvisc] was associated with significant local inflammatory reactions in 27% of patients, or 11% of injections. The mechanism(s) and long term sequelae are unclear.
PMID: 7562764 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/18050181?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
Arthritis Rheum. 2007 Dec 15;57(8):1410-8.
Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis.
Reichenbach S, Blank S, Rutjes AW, Shang A, King EA, Dieppe PA, Jüni P, Trelle S.
University of Berne, Berne, Switzerland.
OBJECTIVE: To compare the effectiveness and safety of intraarticular high-molecular hylan with standard preparations of hyaluronic acids in osteoarthritis of the knee. ... CONCLUSION: Given the likely lack of a superior effectiveness of hylan [Synvisc] over hyaluronic acids and the increased risk of local adverse events associated with hylan [Synvisc], we discourage the use of intraarticular hylan [Synvisc] in patients with knee osteoarthritis in clinical research or practice.
PMID: 18050181 [PubMed - indexed for MEDLINE]
[http://www.wipo.int/pctdb/en/wo.jsp?wo=2006092233&IA=WO2006092233&DISPLAY=DESC ]
Monday, June 15, 2009
Exposure of Pay-Offs--Physicians Payment Sunshine Act
I recently learned of the Physicians Payment Sunshine Act which wants to expose physicians who receive money and benefits from manufacturers of medical devices, medical supplies and pharmaceutical companies.
I applaud this effort as I firmly believe that when my orthopedic surgeon selected Synvisc as the viscosupplemtation for me, he did not consider my severe chemical sensitivities noted to him many times. Several studies printed in peer-review medical journals show that this viscosupplementation produces significantly more adverse events compared to others on the market. I believe my orthopedic surgeon considered the product over this patient, and I'm likely NOT the first, and saddly not the last. It would not surprise me to find a financial connection between the two parties.
This bill has not made if very far in prior congressional sessions, yet fortunately for patients, Senator Grassley of Iowa has not given up. It doesn't take much to realize why the Physicians Payment Sunshine Act has not passed to date. Follow the money. Pharmaceutical companies do not want this kind of exposure, and neither do the members of the American Medical Association. Both highly powerful groups with lobbyist...MONEY buys our laws unless we elect congressman who have ethics and who care.
Pressure your US Congressmen/women to support this into law. Do not be complacent. What do the physicians and drug companies have to hide if the exchange of money and benefits is not unethical?
Sen. Charles Grassley [R-IA] is the sponsor of this bill. To learn more about the status of this bill and co-sponsors, go to www.govtrack.us/congress/bill.xpd?bill=s111-301
Chairman Kohl said, “If these physicians are essentially putting their medical judgment up for sale, where does the patient’s well-being fit into the equation?” Check out report at http://aging.senate.gov/record.cfm?id=294092
Visit Dr Charles Rosen's site for more information on his fight to make this happen
http://www.ethicaldoctor.org/
Contact your senator today
http://www.senate.gov/
[Note: this is not meant to be a political statement, favoring one party over the other. This is meant to stimulate change in our government for our health's sake, no matter what side you're on.]
I applaud this effort as I firmly believe that when my orthopedic surgeon selected Synvisc as the viscosupplemtation for me, he did not consider my severe chemical sensitivities noted to him many times. Several studies printed in peer-review medical journals show that this viscosupplementation produces significantly more adverse events compared to others on the market. I believe my orthopedic surgeon considered the product over this patient, and I'm likely NOT the first, and saddly not the last. It would not surprise me to find a financial connection between the two parties.
This bill has not made if very far in prior congressional sessions, yet fortunately for patients, Senator Grassley of Iowa has not given up. It doesn't take much to realize why the Physicians Payment Sunshine Act has not passed to date. Follow the money. Pharmaceutical companies do not want this kind of exposure, and neither do the members of the American Medical Association. Both highly powerful groups with lobbyist...MONEY buys our laws unless we elect congressman who have ethics and who care.
Pressure your US Congressmen/women to support this into law. Do not be complacent. What do the physicians and drug companies have to hide if the exchange of money and benefits is not unethical?
Sen. Charles Grassley [R-IA] is the sponsor of this bill. To learn more about the status of this bill and co-sponsors, go to www.govtrack.us/congress/bill.xpd?bill=s111-301
Chairman Kohl said, “If these physicians are essentially putting their medical judgment up for sale, where does the patient’s well-being fit into the equation?” Check out report at http://aging.senate.gov/record.cfm?id=294092
Visit Dr Charles Rosen's site for more information on his fight to make this happen
http://www.ethicaldoctor.org/
Contact your senator today
http://www.senate.gov/
[Note: this is not meant to be a political statement, favoring one party over the other. This is meant to stimulate change in our government for our health's sake, no matter what side you're on.]
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