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?
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Hey,
ReplyDeleteThanks for the comment. I'm not sure I am willing to go through that again. It was an odd reaction that I had and even though my PCP (never spoke to ortho doc about it) attributed it to several different issues,none of which seemed plausible to me. I believe it was the injection that caused that odd burning sensation.
I'm overly sensitive to drugs as it is. I'll be checking back to se what else you find.
Thanks!
Sarah