FDA Warns Against Off-Label Use of Hyaluronic Acid
The FDA is urging healthcare professionals to discontinue the off-label use of Enhancement Medical’s Expression injectable due to serious adverse events.
About the FDA Warning
According to Medscape, the U.S. Food and Drug Administration (FDA) is expressing concern off-label use of hyaluronic acid as a dermal filler after cosmetic procedures.
The FDA is reportedly issuing a warning against Expression hyaluronic acid being used as dermal filler. The drug is intended for use as a nasal splint after trauma or bleeding. It is not safe for use as a derma filler, such as for cosmetic procedures.
Expression Linked ot Serious Adverse Events
The FDA reports that when Expression is used as wrinkle filler, the adverse side effects can include swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching and the development of hard masses under the skin.
At least one patient who was given Expression hyaluronic acid as a wrinkle filler suffered a facial deformity which may be permanent.
The FDA warns healthcare professionals not to use Expression hyaluronic acid for dermal filler because it was never intended for such purposes, even though the product is FDA approved for other purposes. Consumers and healthcare providers can locate further information on the FDA website.