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FDA links wrinkle fillers to 'serious' side effects

A staff review did not single out any products and a meeting next week is to consider the need for any warnings.

November 15, 2008|bloomberg news

Some people who received injections of dermal wrinkle fillers suffered "serious and unexpected" side effects, such as the loss of control facial muscles, disfigurement and rare life-threatening allergic reactions, U.S. regulators said Friday.

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. 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 can be made from animal collagen or chemicals and are injected into the skin for a younger appearance 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.

Shares of Allergan, based in Irvine, fell $3.33, or 8.5%, to $35.66. Medicis, based in Scottsdale, Ariz., dropped 94 cents, or 7.7%, to $11.24.

The FDA review was released in advance of a Tuesday meeting of agency advisors in Gaithersburg, Md., 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.

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