Shares of Irvine drug maker Allergan Inc. fell Friday on news that regulators received reports of serious problems in people treated with skin-filling injections.
Allergan shares were down as much as 10% before gaining back some ground to a nearly 5% decline near the close of trading.
Allergan makes Juv & #233;derm, which is used to fill out wrinkles in the lower half of the face. Allergan got Juv & #233;derm through its 2006 purchase of Inamed Corp. of Santa Barbara.
The Food and Drug Administration said problems included facial palsy, disfigurement and rare but life-threatening events such as severe allergic reactions and anaphylactic shock.
Regulators said they received a total of 930 problems in the past six years.
Allergan spokeswoman Caroline Van Hove told Reuters that no serious problems were seen in clinical trials of Juv & #233;derm, and the most common problem found since its approval was swelling in less than 1% of patients.
“Juv & #233;derm has a highly favorable safety profile based on long-term use and volume,” Van Hove said.
The FDA said that it plans to ask a panel of outside experts if labels for the skin fillers, including Juv & #233;derm and Scottsdale-based Medicis Pharmaceutical Corp.’s Restylane and Perlane, should be changed.
