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11/21/2008 Problems reported with wrinkle fillers in U.S.
The FDA meets with a panel of specialists to look at the side effects of dermal fillers. Article provided by: Reuters
WASHINGTON (Reuters) – U.S. regulators have received reports of serious and unexpected problems in people treated with wrinkle-fighting injections known as dermal fillers, Food and Drug Administration staff said in a report released on Friday.
The problems included facial palsy, disfigurement and "rare but life-threatening events such as severe allergic reactions and anaphylactic shock," the FDA staff said.
The agency said it received a total of 930 reports of health problems over the past six years. Many included known complications such as minor swelling. The FDA did not identify which products had reports of more serious problems.
The FDA staff said the reports had several limitations such as failing to say when the problems started.
Dermal fillers include Allergan Inc's Juvederm, Restylane and Perlane from Medicis, and Bioform Medical's Radiesse.
The FDA will ask a panel of outside experts that meets on Tuesday if labels for the products should be changed, agency staff said.
Medicis Chief Executive Jonah Shacknai, in an interview with Reuters, said, "We do not see any adverse events that are unexpected or unnoted on our product label.
"We haven't seen anything that is life-threatening," he added.
Allergan spokeswoman Caroline Van Hove said no serious problems were seen in clinical trials of Juvederm, and the most common complaint since its approval was swelling in 0.4 percent of patients.
"Juvederm has a highly favorable safety profile based on long-term use and volume," she said.
An official at Bioform Medical could not immediately be reached for comment.
