The Florida Department of Health issued the following news release:
The Florida Department of Health (DOH), along with the Florida Board of Pharmacy, have joined with the Food and Drug Administration (FDA) to warn consumers to discontinue the purchase and use of Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx or 4EVERON. These drugs are advertised as 'dietary supplements' for treating erectile dysfunction and enhancing sexual performance. However, these products are not approved by the FDA, and they contain ingredients that are undeclared and possibly harmful.
'The deceptive labeling of drugs is a threat to public health,' said DOH Secretary M. Rony Fran�ois, M.D., M.S.P.H., Ph.D., 'I encourage Florida's residents and visitors to be aware of these potentially dangerous products. There is no guarantee on the safety and effectiveness of these products. Consumers, therefore, should make informed decisions by seeking the guidance of a health care professional, instead of opting to self-diagnose.'
DOH urges consumers who have used these products to consult their primary health care provider. DOH also advises consumers to verify the status of any drug with the FDA.
'These products contain active ingredients found in prescription drugs and these ingredients can cause harm if not used under the supervision of a doctor,' said Florida Board of Pharmacy and Drugs, Devices, and Cosmetics Executive Director Rebecca Poston, R.Ph.
According to the FDA, 'chemical analysis by FDA revealed that Zimaxx contains sildenafil, which is the active pharmaceutical ingredient in Viagra, a prescription drug approved in the United States to treat erectile dysfunction. The other products contain chemical ingredients that are analogues of either sildenafil or a pharmaceutical ingredient called vardenafil. Vardenafil is the active ingredient in Levitra, a prescription drug that, like Viagra, is approved in the United States to treat erectile dysfunction. There is no mention of any of these ingredients on any of the illegal products' labeling.'
The undeclared ingredients in these products may interact with nitrates in some prescription drugs and lower blood pressure to dangerous levels. The nitrates are often found in medications that treat diabetes, high blood pressure, high cholesterol and heart disease. Men with these conditions commonly experience erectile dysfunction. Many of these men consider taking the products because they claim to be 'allnatural.' There is no assurance that the ingredients of these products are safe, effective or pure since the manufacturing source of the active ingredients of these products is unknown, according to the FDA.
The Board of Pharmacy protects the health and safety of Florida's residents and visitors by establishing requirements for licensure and through diligent discipline of practitioners who violate practice acts defined by Chapters 120, 456, 465, 499 and 893, Florida Statutes and Rule 64B-16, Florida Administrative Code. The legislative intent of the practice act is to ensure that every licensee practicing in the state of Florida meets minimum requirements for safe practice. The Board's responsibility is to ensure that licensees who fall below minimum competency or who otherwise present a danger to the public are disciplined or prohibited from practicing in the state. The Board also establishes and monitors continuing education of licensees to ensure their knowledge and skills remain current. For more information visit www.doh.state.fl.us/mqa/pharmacy/.Contact: Thometta Cozart, 850/245-4111.
Thometta Cozart, 850/245-4111.
