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FDA Investigating Juvederm, Restylane and Other Wrinkle Fillers | cialis online

FDA Investigating Juvederm, Restylane and Other Wrinkle Fillers

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The Food & Drug Administration (FDA) has scheduled an advisory panel meeting for Tuesday to discuss problems with wrinkle fillers like Juvederm and Restylane. Known as dermal Fillers, these injectable substances used to restore or enhance fullness to the lips or to correct moderate to severe facial wrinkles and folds, such as nasolabial folds. While dermal fillers are approved for the treatment of moderate to severe facial wrinkles, the FDA said that they are increasingly being used to augment and contour tissues.

In the report released today, the FDA said it expects to receive more applications to sell dermal fillers for wrinkles and possibly for contouring the face and body. As a result, the agency said it wants to determine whether improvements are needed in the way the products are studied and labeled.

Over the past six years,  the FDA has received 930 reports of adverse events associated with dermal fillers.  In addition to allergic reactions and anaphylactic shock, derma fillers have been linked to other problems ranging from mild swelling to  facial, lip and eye  palsy, retina vascular occlusion, infection and disfigurement.  The FDA report did not say which dermal fillers had been involved in the most serious reactions.

According to the FDA, 638 reports indicated that patients required treatment with medication, including steroids, antihistamines and oral antibiotics.  Ninety-four reports indicated surgical intervention, 44 of which were among the patients who received drug therapy as well.  Surgical procedures ranged from opening an abscess for drainage of pus, excision of nodules, to biopsy of the lesions, the FDA said.

Nineteen reports indicated patients’ were admitted to an emergency room for immediate medical attention due to severe hypersensitivity reactions such as swollen tongue, difficulty breathing and anaphylactic shock. Twelve patients required hospitalization for extended IV antibiotic therapy and close monitoring. Three patients were monitored for an extended period of time in the clinic. One-hundred thirty-five reports did not specify treatment of adverse events.

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