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藥物警訊

 

Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes

 

AUDIENCE: Dermatology, Pharmacy, Patient


ISSUE: FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. As a result, FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product. See the FDA Drug Safety Communication for additional information and recommendations.


Patients should use Picato gel as prescribed by their health care professionals, and should not use it on an area of skin larger or for a longer period than instructed in the drug label. Also patients should avoid applying the gel in, near, and around the mouth, lips and eye area. Accidental transfer of Picato gel from the hands even after washing has occurred, including through application of make-up and insertion of contact lenses. Applying Picato gel in a manner other than recommended in the product label has been associated with severe skin reactions and eye injuries.


The allergic reaction may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue.


BACKGROUND: Picato is used to treat actinic keratosis, a scaly, crusty lesion on the skin that may be red or yellow in color.


RECOMMENDATION: Patients who experience a severe allergic reaction should stop using Picato gel and seek immediate medical attention. The allergic reaction may include throat tightness, difficulty breathing, feeling faint, or swelling of the lips or tongue. Patients should also stop using the product and contact their health care professionals if they develop hives, itching, or severe skin rash. If accidental eye exposure occurs, flush the eyes thoroughly with water and seek medical care.


Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm459311.htm


美國FDA發布藥物安全警訊,有關使用Picato凝膠(ingenol mebutate)可能發生嚴重過敏反應或帶狀?疹。FDA已接獲數例塗擦Picato凝膠後出現嚴重眼部受傷和皮膚反應之案例報告,且部分案例非按照仿單指示使用。因此,美國FDA擬修改仿單資訊,提醒病人有關此藥之風險,並提供正確使用藥品之方法。


Picato凝膠應由醫療人員指示後使用,且不應大範圍且長時間的塗擦於仿單未指示可使用之皮膚部位。使用時應避免接觸嘴巴、嘴唇和眼睛及其週邊。並小心避免手部接觸到以上區域,如化妝或戴隱形眼鏡時,未依仿單指示使用Picato凝膠可能發生嚴重皮膚反應和眼部受傷。


Picato可用於治療日光性角化症,為一種皮膚出現粉紅色或黃色帶有鱗屑之斑塊或丘疹。


正在使用此藥品之病人若出現嚴重過敏反應如:喉嚨緊縮、呼吸困難、昏厥或嘴唇、舌頭腫脹,麻疹,搔癢或嚴重皮膚疹等應停藥並立即就醫。若不小心接觸到眼睛,應立即以清水沖洗並尋求醫療人員協助。


相關訊息與連結請參考FDA網址:


http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm459311.htm
[Posted 08/22/2015]


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

 

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