[8-9-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use De Guo Hei Bei (徳国黑倍), a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that De Guo Hei Bei (徳国黑倍) contains sildenafil. Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
- Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
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