Internet-Sold Dietary Supplements For Erectile Dysfunction May Endanger Users

Dietary supplements sold over the Internet to treat erectile dysfunction or enhance a man’s sexual performance may pose a health risk, the Food and Drug Administration (FDA) has warned consumers.

An FDA warning, issued July 12, 2006, says that the dietary supplements — which are unregulated, even by the FDA — may contain prescription drugs or chemicals similar to those drugs. This has been a recurring problem with many dietary supplement manufacturers who illegally, and without stating such on the label, add prescription drugs to achieve effectiveness for their otherwise useless products.

People who take the supplements could be in danger if they take other prescriptions because the interaction of the various drugs could lead to dangerously low blood pressure.

In a first-of-its-kind FDA survey, the agency analyzed 17 dietary supplements marketed on the Internet to treat erectile dysfunction or to enhance sexual performance in men. The FDA analysis found that some of these products contained sildenafil (VIAGRA), which is FDA-approved for erectile dysfunction. Others contained chemicals similar to sildenafil or vardenafil (LEVITRA), which is also approved by the FDA for erectile dysfunction. But there was no mention of any of these drugs on the labels of the dietary supplements tested by the agency.

A third drug, tadalafil (CIALIS), is also FDA-approved for erectile dysfunction. Although this drug was not specifically mentioned in the FDA warning, it is entirely possible that traces of this chemical are also used in dietary supplements for erectile dysfunction as well. The FDA survey only looked at 17 drugs but the actual number of dietary supplements being sold for erectile dysfunction over the Internet is unknown. The total number of dangerous dietary supplements for erectile dysfunction is therefore probably not limited to those listed in this article.

The FDA has identified the following supplements as those that contain the drugs or chemicals similar to the drugs: 4EVERON, Actra-Rx, Libidus, Nasutra, Neophase, Vigor-25 and Zimaxx.

The makers of these products claim that they are “all natural” or that they do not contain the active ingredients used in FDA-approved erectile dysfunction drugs. In addition, because the manufacturing source of the active ingredients in these supplements is unknown, there is no assurance that the ingredients are safe, effective or pure.

Public Citizen recommends that the FDA seek criminal indictments for these companies, which are putting the lives of consumers at risk.

More risks for erectile dysfunction drugs

There are other potentially serious health risks related to knowingly or unknowingly taking one of the drugs for erectile dysfunction.

On October 20, 2005, Public Citizen petitioned the FDA to add black box warnings about the possibility of irreversible vision loss to the professional product labels, or package inserts, for sildenafil, tadalafil and vardenafil. The petition also urged the FDA to require pharmacists to distribute patient medication guides with each new and refill prescription for these products to warn consumers about the possibility of irreversible blindness.

The full text of the petition is available on our Web site at www.citizen.org/publications/ release.cfm?ID=7403.

American consumers face an unacceptable level of potential harm from all dietary supplements sold in this country because of the dietary supplement industry’s lobbying efforts and an irresponsible Congress. The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, placed dietary supplements into a new of drugs which do not require proof of safety or efficacy. Dietary supplements can be produced in facilities without procedures that ensure the quality of the final products. DSHEA eliminated any FDA oversight of dietary supplements, which opened the door for untested products to be promoted for totally unsubstantiated uses.

It is outrageous and unacceptable for companies to knowingly add prescription drugs to products that are promoted to consumers as being natural and safe. The FDA merely sends these companies warning letters. This action is passive and toothless, and it points to the inability of the agency to protect the public. The FDA is commending itself for taking this action, but the action is grossly inadequate for this kind of recurrent problem.

What You Can Do

You should not take any dietary supplements, including those promoted for erectile dysfunction or sexual enhancement.