Comments on: Not So Smooth: Wrinkle Fillers Need Warnings

By: Fda Regulatory Affairs

Fda Regulatory Affairs — Mon, 27 Apr 2009 13:51:32 +0000

U r correct.

By: laura

laura — Mon, 27 Apr 2009 01:39:23 +0000

Yes.

By: EILEEN

EILEEN — Tue, 17 Feb 2009 16:58:17 +0000

IS THIS THE STUFF THEY INJECT IN BAD KNEES

By: laura

laura — Wed, 19 Nov 2008 02:24:09 +0000

Actually, Synvisc has over 500 adverse events reported on the FDA’s MAUDE database. (The MAUDE database is the FDA’s database that provides medical device adverse event reports. It can be accessed through the FDA website)
MAUDE has 283 adverse event reports for Seprafilm, another Genzyme product that is made with Hyaluronic Acid. It’s interesting that the FDA advisory panel is asking that facial fillers, which are made with Hyaluronic Acid, modify their labeling, and yet other products that are made with Hyaluronic Acid and have had significant adverse events reported (reactions that could have much more significant outcomes) are apparently not being investigated.

By: pharma PR hack

pharma PR hack — Wed, 19 Nov 2008 00:48:20 +0000

The thing is Hyaluronic acid isn’t just made for cosmetic uses– Genzyme’s Synvisc and others in that class are hyaluronic acid which is injected into the synovial fluid sac as a cushion for those suffering from osteoarthritis. How can Juvederm’s and Medicis’s formulations of HA be causing all these side effects without HA being used for osteoarthritis also triggering side effects? As a point of reference HA for osteoarthritis has been around much longer.

By: An FDA Reviewer

An FDA Reviewer — Tue, 18 Nov 2008 23:53:38 +0000

Sorry. I have no knowledge.

I don’t even know what the MAUDE database is. Everything has some side effects, nothing is 100% safe. As for frequency of reporting patient reporting systems can easily collect 10’s of thousands of reports of common side effects in a couple of months, whereas health care reporting databases are notorious for underreporting. No one wants to bother and when they do they don’t typically provide adequate documentation to make and assessment.

In general I don’t want to get into specific drugs or specific cases. My purpose here is to let people know how bad things really are and to raise the alarm that there’s some real major problems coming down the pike unless something is done.

By: laura

laura — Tue, 18 Nov 2008 22:45:18 +0000

…BTW, I would love to hear from anyone else, besides FDA Reviewer who might have information about Hyaluronic Acid, as well.

By: laura

laura — Tue, 18 Nov 2008 22:42:19 +0000

This is a question for FDA Reviewer…do you know anything about medical devices that contain one of the main ingredients in these facial fillers, Hyaluronic Acid? This is an ingredient that is touted as being absolutely safe, and yet adverse reactions are reported frequently on the MAUDE database for products containing this ingredient. Any information that you can provide is greatly appreciated.