ST LOUIS (MD Consult) - On October 27, 2010, the US Food and Drug Administration (FDA) announced that Intelli Health Products is conducting a voluntary nationwide recall of Duro Extend Capsules for men. The product is being recalled because an FDA laboratory analysis found it to be adulterated with sulfoaidenafil, an analogue of sildenafil, which is an FDA-approved drug used in the treatment of erectile dysfunction (ED), making it an unapproved new drug.

Use of this product may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, hypertension, hypercholesterolemia, and heart disease often take nitrates, and because ED is a common problem in men with these conditions, these men may seek these types of products to enhance sexual performance.

Duro Extend Capsules are sold nationwide. The products are sold as a blister pack containing 1 capsule per unit and in 24-packs per box.

Consumers with Duro Extend Capsules in their possession are being advised to stop using them immediately. In the event of any adverse effects associated with consumption of these products, consumers are instructed to contact a physician immediately. Adverse events that may be related to the use of these products should be reported to the FDA's Med Watch Program.

圣路易斯(MD Consult)——2010年10月27日，美国食品药品管理局(FDA)宣布，Intelli Health Products公司正在全美范围内主动召回用于男性的Duro Extend胶囊。被召回的原因是FDA实验室分析发现该产品混有西地那非类似物sulfoaidenafil，后者是一种经FDA批准用于治疗勃起功能障碍(ED)的药物，这使Duro Extend成为一种未经获准的新药。

由于该类似物可能与某些处方药(如硝酸甘油)中的硝酸盐相互作用并可能使血压降至危险水平，故使用该产品可能会对消费者造成威胁。患有糖尿病、高血压、高胆固醇血症和心脏病的消费者经常使用硝酸盐类药物，而ED是患有以上疾病男性患者的一个常见问题，故这些男性可能会寻求以上类型的药物以增强性功能。

Duro Extend胶囊在全美范围内销售，以泡罩包装的形式出售，1粒胶囊/单位，24粒/盒。

FDA建议有Duro Extend胶囊的消费者立即停用此药。若消费者有任何与使用这些产品有关的不良反应，则应立即联系医生，并应将与使用该产品相关的不良事件上报至FDA's Med Watch Program。