Pharmaceutical

FDA warns of side effects from unapproved use of Expressions product as dermal filler

fda logo FDA warns of side effects from unapproved use of Expressions product as dermal fillerThe Food and Drug Administration (FDA) is warning doctors that Expression brand injectable product made by Enhancement Medical should not be used as a dermal filler because the product has not been approved for this use and adverse events have been reported. These events include swelling, tenderness, firmness, lumps, bumps, bruising, pain redness, discoloration, itching, and the development of hard nodules.

Expression is a hyaluronic acid, and is approved by the FDA only as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent the septum and the nasal cavity from sticking together. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material. It is not approved to be used as a dermal filler, as in plastic surgery procedures.

Doctors have the authority to prescribe drugs and drug products “off-label,” or for uses for which they are not approved by the FDA. However, drug companies cannot market drugs or products for unapproved uses. In this case, the FDA became aware that the adverse events were associated with Expression hyaluronic acid packaged in a syringe for use as a dermal filler.

One adverse event report involved a patient who developed firm masses in the face after being injected with the Expressions product as a dermal filler. An attempt was made to dissolve the masses, but the patient was left with an “obvious deformity.”

While the Expressions product contains similar components to FDA-approved dermal fillers, the product has never undergone an FDA review for such use nor is the agency aware of any clinical trials that support its safety and efficacy for this use. Without reviewing clinical data supporting the safety and effectiveness of this product, the FDA says it cannot fully understand the nature, severity, or rate of occurrence of adverse events associated with this product, nor can it assure the product’s safety and effectiveness when used as a dermal filler.

The FDA is recommending health care providers to stop using Expression by Enhancement Medical as a subcutaneously administered substance and instead use the list of FDA-approved fillers. Patients who have received treatment with Expression as a dermal filler should be monitored for adverse events and referred for corrective treatment if necessary.

Any side effects from this unapproved use of Expression as a dermal filler should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA