藥物警訊（藥師週刊 第1727期）

X-Hero and Male Enhancer: Recall - Undeclared Drug Ingredient

AUDIENCE: Consumer

FDA lab analysis of X-Hero found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug. In addition, FDA analysis of Male Enhancer sample found the product contains tadalafil, the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Male Enhancer an unapproved drug.

The products pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance.

BACKGROUND: These two products have been distributed nationwide via retail stores, internet sales and mail order. See the Firm Press Release for a listing of affected products and lot numbers.

RECOMMENDATION: Consumers who have X-Hero or Male Enhancer in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA分析發現X-Hero產品中含有sulfosildenafil，與FDA核准用來治療勃起功能障礙的藥品是類似物，故X-Hero成為未經核准的 藥品；另外，FDA也發現Male Enhancer產品中含有tadalafil，是FDA核准用來治療勃起功能障礙的藥品，故Male Enhancer成為未經核准的藥品。這些產品因為可能與nitrate類藥物（如nitroglycerin）有交互作用，會過度降低血壓，所以會對使 用者造成威脅。有糖尿病、高血壓、高膽固醇或心臟疾患的人常會服用nitrate類藥物，而勃起功能障礙在有這些疾病的男性病人是常見的問題，他們可能會 尋求產品來增強性能力。

這二項產品經由零售店、網路及郵件而販賣至各個國家，詳見FDA網站上產品的批號。

建議使用X-Hero或Male Enhancer的人應立即停止使用，如果有任何問題請聯繫醫師因為可能是與該產品相關。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm248814.htm
[Posted 03/29/2011]

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