By Justin Blum
Nov. 14 (Bloomberg) -- Some people who received wrinkle- fillers suffered ``serious and unexpected'' side effects such as the inability to control facial muscles, disfigurement and rare life-threatening allergic reactions, U.S. regulators said.
There were 930 reports of side effects of all types from January 2003 to Sept. 20 of this year for products made by various companies, according to a Food and Drug Administration staff review posted today on the agency's Web site. The reports came from the U.S. and elsewhere.
The FDA didn't specify how many side effects were serious, or which products were linked to them. Among top-selling fillers are Medicis Pharmaceutical Corp.'s Restylane and Allergan Inc.'s Juvederm. The products, also called dermal fillers, can be made from animal collagen or chemicals and are injected into the skin to make it look younger or to reduce scarring.
Many of the reported side effects, such as minor swelling, ``are expected problems'' described in FDA-approved literature for the products, the agency's staff said.
Allergan, based in Irvine, California fell $3.33, or 8.5 percent, to $35.66 at 4:01 p.m. in New York Stock Exchange composite trading. Medicis, based in Scottsdale, Arizona, dropped 94 cents, or 7.7 percent, to $11.24.
The FDA review was released in advance of a Nov. 18 meeting of agency advisers in Gaithersburg, Maryland, to discuss the safety of the products and whether new warnings are needed. The FDA usually follows the recommendations of its panels, though it isn't required to do so.
Filling, Contouring
The agency expects more applications to sell dermal fillers for wrinkles and possibly for contouring the face and body, according to the staff report. As a result, the agency said it wants to determine whether improvements are needed in the way the products are studied and labeled.
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 staff report said.
Medicis hasn't received reports of serious side effects such as disfigurement or inability to control facial muscles associated with its products, said Jonah Shacknai, the company's chairman and chief executive officer, in a telephone interview.
Medicis has an ``outstanding'' safety record with its dermal fillers, which have been used more than 10 million times worldwide, he said.
``We applaud the FDA's inquiry into the safety of dermal fillers,'' Shacknai said.
Allergan Response
Allergan's product has a ``very strong safety profile,'' said Caroline Van Hove, a spokeswoman for the company. ``We have a very low adverse event reporting rate,'' she said in a telephone interview.
Non-surgical cosmetic procedures increased more than eightfold between 1997 and 2007, according to the American Society for Aesthetic Plastic Surgery.
About 1.36 million women and 84,000 men received wrinkle- fillers last year, according to the plastic surgery group. Allergan's Botox, a toxin injection, relaxes facial muscles and isn't included in the review.
To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.
Last Updated: November 14, 2008 16:12 EST
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