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FDA Panel Recommends Stronger Derma Filler Warnings

Posted by Chrissie Cole
Wednesday, November 19, 2008 11:18 AM EST
Category: Major Medical
Tags: Botox, FDA and Prescription Drugs, Cosmetic Procedures, Juvederm, Restylane, Dermal Fillers


IMAGE SOURCE:© iStockPhoto / Botox beauty treatment / mschenk

An FDA advisory panel suggests stronger, more specific warning labels about potential adverse side effects on dermal fillers injected to soften facial wrinkles.

The panel convened on Tuesday to review many questions about the fillers, including popular brand names Juvederm (Allergan) and Restylane (Medicis Pharmaceutical Corp).

Panel members “agree that the labeling should be revised to include: more serious side effects, how long the product has been on the market and how long it might take before side effects appear,” says Siobhan DeLancey, an FDA spokeswoman.

While the current labels do include several potential adverse effects, they do not always list when the events might occur. An FDA evaluation found that some events can show up months after the injection, she says.

Some plastic surgeons and industry representatives say stronger labels are unnecessary, while other experts welcome the labeling recommendations.

Types of Adverse Events

The agency Web site notes 930 side effects connected to the use of wrinkle fillers, most of which occurred over the last 10 years.

Of those, 823 were classified as injuries, including bleeding, infection, lumps or bumps in the face and in some rare cases, facial disfigurement.

684 of the reports needed medical intervention, including 100 patients who required a surgical procedure. About 20 were treated in the emergency room for allergic reactions.

No deaths have been reported.

Most of the reported adverse events involved injections in sites other than the nasolabial fold (two skin folds that run from each side of the nose to the corners of the mouth), according to the FDA.

The agency also found that several reports of adverse reports involved injections by untrained personnel.

The panel reviewed dermal fillers as whole and not specific products.

Advisory Panel Recommendations

The panel is advising the FDA to require manufacturers to note that some events can occur months and sometimes years after injection.

The panel didn’t agree on whether the label should list adverse events for all fillers in that class, or on the adverse events associated with a specific filler type.

The panel also reviewed how future clinical studies on dermal fillers should be done and concluded that “there is no one-size-fits-all study,” says DeLancey.

“Some products seem to have more reactivity than others,” she tells WebMD. The panel plans to assemble a consensus panel to develop guidelines on how clinical studies should be done and formulate guidance for the industry. “Several members say they want manufacturers to do more rigorous premarket studies.”

Wrinkle fillers work by plumping up the skin at wrinkle lines such as around the mouth. They first appeared on the market 20 years ago, but the latest batch has been approved in the last 10 years.

Fillers are made from animal collagen or chemicals.

About 1.36 million women and 84,000 men received the injections last year, primarily for cosmetic reasons, but they are also given to HIV patients to counteract a gaunt look. #

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