Labels of popular cosmetic wrinkle fillers should carry
stronger warnings about potential side effects, according to an advisory panel
of the Food and Drug Administration.
The panel met Tuesday in
The member of the panel agreed that, “the labeling should be revised to include the more serious adverse events and how long the product has been on the market and how long it might take events to appear,” Siobhan DeLancey, an FDA spokeswoman who was at the meeting, said.
Current labels of the products are inadequate reading only immediate and temporary side effects such as swelling.
The decision follows an FDA review posted on the agency’s Web site. According to it, more and more people using wrinkle fillers experience medical problems later. A total of 930 reports of health problems have been received over the past six years (from January 2003 to September 20th of this year). Side effects include facial palsy and disfigurement and rare, but life-threatening problems such as severe allergic reactions and anaphylactic shock.
Among the reports, 19 were from people admitted to the emergency room for severe allergic reactions, 638 patients required treatment with medication, which included steroids, antihistamines and oral antibiotics. Also, 94 patients required surgical intervention (opening the abscesses, excision of nodules and biopsy of lesions), which included 44 that had also received drug therapy. The other reports did not include specific treatments for conditions.
The panel’s decision, if approved by the FDA, would affect such manufacturers as Allergan Inc., Sanofi-Aventis SA, Medicis, Artes Medical Inc., and BioForm Medical Inc.
Overall, about 1.36 million women and 84,000 men received the injections last year, primarily for cosmetic reasons, but they are also given to HIV patients to counteract a gaunt look. According to the American Society for Aesthetic Plastic Surgery, non-surgical cosmetic procedures increased more than eightfold between 1997 and 2007.