FDA Warns about Illegal ED Drugs


July 12, 2006 - The U.S. Food and Drug Administration –

Seven dietary supplements, widely advertised and sold in the Internet as the drugs against erectile dysfunction, are claimed by American Food and Drug Administration (FDA) to be potentially harmful for the health of patients.

Zimaxx, Libidus, Neophase, Nasutra, Vigor-25 and 4EVERON are mentioned in the FDA official press-release as those, which have not been approved for the use as food supplements or medications on the territory of the United States of America. Consequently, all the above mentioned products are illegal and there is no guarantee of their safety, effectiveness and purity of their components.

FDA recommends people, who have already used any of the said products, to stop using them and to consult their doctors or health care providers. FDA says that all the people, who suffer from any sexual disorder and especially from erectile dysfunction, should seek for medical help, diagnosis and approved treatment.

Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research, underlined the fact that the above mentioned products contained undeclared chemicals, not mentioned on the products' labels. These components may be similar or even analogue to the active ingredients of FDA-approved medications. For example, Zimaxx contains sildenafil, which is a main working agent of the prescription drug Viagra; other products may also contain vardenafil, which is the ingredient of another ED medication Levitra.

It is known that the approved ED drugs cannot be used in combination with some other medications, for example, nitrates, which are used to treat high blood pressure, diabetes or high cholesterol. Sildenafil and other similar chemicals in combination with nitrates may lower the blood pressure to the life-threatening level. That is why it is important to use ED drugs only in strict accordance with the medical guidance and prescription. On the other hand, a person, using illegal drugs, like Zimaxx, Vigor and others, may not even know the components of a product, which may lead to serious health risks.

The FDA has sent the letters to firms, marketing the said products, warning them about the illegal status of their products; therefore they cannot be sold in the USA. The letters also state that the products’ labels are false and misleading because they do not inform consumers about the chemical ingredients or the potential side-effects, associated with the products’ consumption.

Moreover, the agency works to stop importation of dangerous products into the country. Recently the FDA stopped a shipment of 4EVERON from entering the American market. Thus, the agency has once again proved its role as a guard of public health in the USA.

The recent press-release is called to draw consumer’s attention to the problem of fraudulent drugs, promoted over the Internet as the means to improve sexual performance. For the time being, the only FDA-approved drugs to treat erectile dysfunction are Viagra, Levitra and Cialis.

Nick


External resources
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01409.html
http://www.webmd.com/content/article/124/115776.htm


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