FDA Reports Side Effects Linked to Wrinkle Fillers

Associated Press

A doctor prepares to use Restylane on a patient

An ugly side of the beauty business emerged today, as an FDA briefing listed 930 reports of side effects for injectable wrinkle fillers such as Restylane and Juvederm.

The reports go back to 2003, and include swelling, allergic reactions and infections, among other problems. The briefing says there’s not a clear causal link between the products and the side effects, and doesn’t specify which products were involved.

But shares of Medicis, which makes Restylane, closed down 7.4%, and shares of Allergan, which makes Juvederm, fell 6.9%. (For comparison, the S&P 500 closed down 4.2%.)

The briefing will be chewed over at an advisory board meeting next week, where a bunch of experts will look at safety issues connected to so-called dermal fillers.

A Medicis spokesman told Bloomberg that the company has an “outstanding” safety record with its dermal fillers, which have been used more than 10 million times worldwide. An Allergan spokeswoman said the company’s filler has a “very strong safety profile,” and a “very low adverse event reporting rate.”