Injectable pharmaceuticals aimed at smoothing out fine lines and deeper wrinkles are becoming increasing popular. Last year, about 1.36 million women and 84,000 men received such injections, make from animal collagens or synthetic chemicals, to help maintain a youthful appearance.
According to FDA staffers, current prescribing information describes most of the side effects as temporary and noticeable for only a short period. However, side effects that are more serious include scarring and permanent tissue damage, which the current prescribing information downplays. In fact, according to FDA briefing documents filed in between January 2003 and September 2008, 930 side effects were reported. The manufacturers point out that this is less than 1 percent of procedures performed, but FDA staffers noted that it is likely that the side effects are under-reported.
The intent of the FDA meeting was to review products from Allergan, which makes Juvederm, and Medicis Pharmaceuticals, which makes Restylane. The panel discussed modifying the labels as experts learn more about the risks associated with the injections.
The agency does not have to take the advisors' advice, although it typically does. Still, the panel has not voted formally about increasing warnings on the labels at this time.