FDA asks dermal filler makers to indicate risk of serious injury
May 28 (Reuters) - The U.S. Food and Drug Administration has asked manufacturers of dermal fillers to update their labeling to reflect the possible risk of serious injuries caused by unintentional injection of the fillers into the blood vessels in the face.
The agency said on Thursday it had reviewed information suggesting that the fillers could block blood vessels and restrict blood supply to tissues, potentially leading to vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.(1.usa.gov/1J5fzyX)
While current labeling includes some information about this risk, the FDA said it believed that additional information could be included to better inform health care providers and patients.
(Reporting by Anjali Rao Koppala in Bengaluru; Editing by Ted Kerr)
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