Panel advices stronger label warnings for wrinkle fillers

New York, November 19: With mounting evidence linking dermal fillers, popular beauty-enhancing products used to lighten wrinkles, with "serious and unexpected" adverse effects, the US Food and Drug Administration’s advisory panel Tuesday recommended a product labeling warning for the same.

The FDA advisory panel scheduled to meet on Nov. 18 in Gaithersburg pronounced, "The labeling should be revised to include the more serious adverse events and how long the product has been on the market and how long it might take events to appear."

Besides, the advisory panel has also called for a new large scale study that would typically evaluate long-term safety of dermal fillers across different ethnic groups.

While the panel has put forward its final recommendations, the FDA, which can reject them, in part or in total, will make the final call.

The products particularly implicated by the FDA decision would include Medicis’s Restylane and Perlane, Allergan Inc’s Juvederm and Bioform Medical’s Radiesse.

The review panel was to review certain wrinkle-filler products after reports of almost 930 cases of adverse effects poured in since 2003.

While the FDA-approved literature for the product already contained information about temporary side effects like redness, pain and tenderness during injections and swelling and bruising at the injection sites, more ‘serious and unexpected’ side effects like inability to control facial muscles, disfigurement and rare life-threatening allergic reactions were now propping up even years after receiving the treatments, FDA had noted.

Made from animal collagen, the dermal fillers typically comprise of hyaluronic acid, a substance found in the skin, muscles, and tendons of mammals. Administered as small pricks in problem areas, the technique promises smoother skin with lightened facial wrinkles.