In a recent alert the US Food and Drug Administration (FDA) warned consumers against the use of illegal products promoted on the Internet as dietary supplements for erectile dysfunction (ED) and the enhancement of sexual performance. Consumers who have used these products or require treatment for ED are encouraged to consult a healthcare professional for guidance.
The products that are not FDA-approved such as Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, and 4EVERON may contain potentially harmful undeclared ingredients. Because some of these undeclared chemicals are similar or identical to active ingredients used in several FDA-approved prescription products for ED, their use represents a potential danger from drug interactions.
The warning occurred based on the results of a chemical analysis of 17 Internet-promoted products. Zimaxx contains sildenafil citrate (Viagra, made by Pfizer, Inc), and other products featured analogues of sildenafil or vardenafil HCl (Levitra, made by Bayer Pharmaceuticals Corporation). Interaction of these products with nitrates found in some prescription drugs can lead to potentially dangerous hypotension.
Men requiring nitrate therapy for conditions such as diabetes, high blood pressure, high cholesterol, or heart disease often have ED and may be more likely to take the unapproved ED products because of their claims about being “all natural” or that they do not contain the active ingredients found in FDA-approved drugs. Moreover, the manufacturing source of the active ingredients in these “dietary supplements” is unknown and there is no assurance that the ingredients are safe, effective, or pure.
The FDA has also sent letters to the marketing firms involved warning that the claims made for the products or their ingredients render them illegal. The letters also inform the firms regarding the deceptive nature of the product labeling for failing to disclose the presence of chemical ingredients and the potential for adverse events. Importation of Libidus and 4Everon into the US is no longer allowed; more enforcement measures will be implemented as needed.
Additional information regarding illegal ED drugs may be obtained by contacting the FDA at 1-888-INFO-FDA (463-6332). Healthcare professionals are encouraged to report adverse events related to use of these illegal products to the FDA’s MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.