ST LOUIS (MD Consult) - On July 14th and 16th, 2009, the US Food and Drug Administration (FDA) announced voluntary recalls of several products sold by Haloteco and the Nature and Health Co. Haloteco is recalling a product known as Libipower Plus, and the Nature and Health Co is recalling products sold under the following names: LibieXtreme, Y-4ever, Libimax X liquid, Herbal Disiac, and Powermania (liquid and capsules).

Laboratory analysis of Libipower Plus samples showed that they contain undeclared tadalafil, an active ingredient of FDA-approved drugs for erectile dysfunction (ED). Laboratory analysis of the products sold by the Nature and Health Co revealed that they contained either tadalafil, its analog aminotadalafil, or the analog of sildenafil, an active ingredient in another FDA-approved ED drug. None of the active drug ingredients are listed on the product labels. The FDA classifies the recalled products as unapproved drugs.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (eg, nitroglycerine) and may lower blood pressure to dangerous levels. Consumers considered at risk for adverse effects from these products because they take nitrates include those with diabetes, hypertension, high cholesterol levels, or heart disease. Other adverse affects that may occur with the use of these products include headaches and flushing.

Libipower Plus is sold as a 1-capsule blister pack through distributors and retail stores in California. The 6 recalled products sold by the Nature and Health Co listed in the table below were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio.

 

 

Patients who have any of these products in their possession should be advised to immediately discontinue use and seek medical care if they have experienced any problems that may be related to their use. In addition, any adverse events that may be related to the use of these products should be reported to FDA's MedWatch Program online, by telephone (1-800-FDA-1088), or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, Md 20852-9787, or by fax to 1-800-FDA-0178.

 

圣路易斯(MD Consult)——9年7月14日和16日，美国食品药品管理局(FDA)宣布，Haloteco和Nature & Health 有限公司自愿召回其上市的多种药品。Haloteco召回中的药品名为Libipower Plus，而Nature & Health有限公司召回中的已上市药品名包括LibieXtreme，Y-4ever，Libimax X 液，Herbal Disiac以及Powermania(液剂及胶囊)。

Libipower Plus实验室抽样检查分析结果显示，该药含有未申报的他达那非成分，即FDA已批准的勃起功能障碍(ED)治疗药中的一个有效成分，Nature & Health有限公司上市的上述药品的实验室分析结果揭示，含有他达那非，或其类似物氨基他达那非，或西地那非类似物(FDA批准的另一个ED治疗药的有效成分)。上述有效药物成分均未在药品说明书中明示。FDA将这些被召回的药品归为非法药品类。

这些药品中未申报的成分可能会与某些处方药(如硝酸甘油)中含有的硝酸盐成分发生相互作用，并会将血压降至危险水平。患者因患有下列疾病同服含硝酸盐成分的药品和这类药品会有发生不良反应的风险：糖尿病，高血压，高胆固醇血症，或心脏病。与此类药品同服还可能发生头痛和面部潮红等其他不良反应。

Libipower Plus在加利福尼亚州通过分销商和零售店出售的药品包装形式为单粒胶囊水泡眼包装。由Nature & Health Co公司出售的6种被召回药品(如下表所示)曾分别在加利福尼亚州、乔治亚州、伊利诺斯州以及俄亥俄州的零售店出售。

 

 

无论患者存有上述何种药品，均应建议其立即停药，且一旦出现任何与使用此类药品可能有关的问题时，应前去医院就诊。此外，对于任何一个可能与使用此类药品有关的不良事件，均应报告至FDA Medwatch系统，报告方法包括：上网在线报告，致电1-800-FDA-1088，以及将邮资已付的FDA 3500表邮至MedWatch 5600 Fishers Lane, Rockville, Md 20852-9787，或发传真至1-800-FDA-0178。