Not So Smooth: Wrinkle Fillers Need Warnings
5 CommentsBy Ed Silverman // November 18th, 2008 // 2:19 pm
Such as? Scarring and tissue damage, among other serious complications. That’s what an FDA advisory panel concluded at a meeting to review products from Allergan and Medicis Pharmaceuticals. FDA staffers told the panel that current prescribing info inaccurately describes most side effects as quickly noticeable and temporary, Bloomberg News writes.
About 1.36 million women and 84,000 men opted last year to get injections of animal collagens or chemicals to smooth facial skin and reduce signs of aging, according to the American Society for Aesthetic Plastic Surgery. Briefing documents filed with the FDA listed 930 side effect reports between January 2003 and September 2008 (please see page 23) with such products as Medicis’ Restylane and Allergan’s Juvederm. Actual numbers could be higher, of course, because reporting can be cumbersome.
“The labeling should be modified to reflect what we’re learning further about the products” through post-approval studies and reported side effects, panel member Mary McGrath, a professor of surgery at the University of California in San Francisco, said at the meeting. The panel, however, didn’t take a formal vote, and recommendations are not binding on the FDA.
The injections are generally given by doctors who have the responsibility to spell out risks and benefits to patients. Some injections that resulted in side effects may have been performed “by untrained personnel or in settings other than health clinics or doctors’ offices,” the FDA said in briefing documents released before the meeting.
laura
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.
laura
…BTW, I would love to hear from anyone else, besides FDA Reviewer who might have information about Hyaluronic Acid, as well.
An FDA Reviewer
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.
pharma PR hack
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.
laura
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.