藥物警訊

Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler

AUDIENCE: Dermatology, Surgery, Dentistry, Nursing

ISSUE: The FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.

BACKGROUND: Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material.

The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection.

RECOMMENDATION: FDA recommends that health care providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance and instead use the list of FDA approved fillers. In addition, patients who have received treatment with Expression as a dermal filler should be monitored for adverse events and referred for corrective treatment when appropriate. For further detailed instructions for people undergoing procedures that use dermal fillers or their health care providers please see the FDA Safety Communication.

Read the MedWatch Safety Alert, including links to the FDA Safety Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA警告Expression公司生產之含有玻尿酸的鼻腔用固定劑未核准作為臉部除皺之皮膚填充物。不適當使用可能產生不良反應，如紅、腫、痛、瘀青、色斑、癢和產生硬塊等。

背景：Expression公司經FDA核准上市的產品為鼻腔用固定劑，用途為減少出血和腫脹，避免鼻中膈與鼻腔黏在一起，鼻腔用固定劑在術後使用於鼻腔內或傷口處，通常由塑料、矽膠或可吸收的材料製成。

建議：FDA建議醫療人員應使用FDA核准之皮膚填充物，此外，已使用Expression產品做為皮膚填充物之病人應持續觀察是否出現副作用，並適時轉介治療。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部