The health threats of non-FDA approved and herbal medications to treat erectile dysfunction

Herbal and Non FDA Approved Medications for Erectile Dysfunction May Pose Serious Health Threats

By Stanley Ducharme, Ph.D.

Since the release of Viagra in March 1998, there has been a tremendous number of herbal and "Viagra-like" products marketed in the United States and around the world. These range from herbal remedies, devises to enlarge the penis, various non-approved medications, penile stretching exercises, vacuum devises and transdermal patches to improve sexual desire.

Today, the advertising of sexual related products is inescapable. Products aimed at sexual enhancement are advertised in respectable magazines, newspapers, television ads, web sites and in prolific, unsolicited spam emails. Improving sexual performance has become big business! Recently, however, concerned experts have been reporting that these herbal supplements and sexual medicines are not as safe and effective as touted by their developers.

Slowly but increasingly, new sexually related complications are being seen in clinics and hospitals. Men, as well as women, have begun to report a variety of conditions often leading to permanent sexual difficulties. On occasions, the complications have extended far beyond sexual dysfunction and individuals have reported serious cardiovascular consequences from these new therapies. Working in a sexual health clinic, my own clinical practice has further confirmed this fact. Many sexual problems seen today are a direct result of unproven and medically unsupervised procedures.

Currently, about 350,000 web sites sell fake Viagra or link you to a site that does. Often, the names sound very much like Pfizer's universally recognized Viagra. Usually, however; these are fake medications developed under the worst of circumstances and under a complete lack of governmental regulation. The marketing ploy is to confuse and trap the consumer. These web sites and the products they promote are directed toward a man's most vulnerable area: his sexual performance.

Most of these sites look very legitimate and informative. However, in spite of their professional appearance, they often are misleading and make medical claims that are deceiving. Many drugs, which are typically sold online, are not approved by the FDA, are considered illegal by the US government and often contain unknown or potentially harmful substances.

Furthermore, many forms of "generic Viagra" are made in developing countries such as India or in unregulated factories and warehouses throughout the world. Although web sites may promote these drugs as having similar effects as Viagra, there is no proof that these medications are safe and effective. To the contrary, they could be more harmful than beneficial.

At this year's American Urological Meeting in San Francisco, a study by researchers at the University of Toronto found that several of the herbal sexual treatments contained manufactured phosphodiesterase inhibitors at pharmacologic dosages. These PDE 5 inhibitors are the active ingredients in Viagra, Levitra and Cialis, the only products thus far approved by the FDA.

PDE-5 inhibitors are contraindicated in patients taking nitrates and in certain renal and hepatic impairments. The ingredients in Cialis are also contraindicated in patients taking certain blood pressure medications. Combining these ingredients with other medications may have serious or fatal consequences. Yet, no list of ingredients and no warning labels are provided on the packaging of non-approved medications.

In the Toronto study, two of the herbal medications called, "Super X" and "Stamina Rx" were found to contain significant amounts of PDE-5 inhibitors. Yet, in spite of the potential danger of the side effects, neither of these medications listed the ingredients on the label or in the promotional material. For a man on nitrates, these potentially harmless herbal medications could cause serious side effects or even death.

In my own clinical practice, centered in a busy Urology and Sexual Medicine office, I have seen a number of patients who have developed severe sexual dysfunctions as a direct result of material touted in online advertisements or spam emails. Several patients have presented with severe erectile dysfunction or penile curvature as a result of using treatments aimed at increasing the length of the penis. The emotional consequences to patients and their spouses have been devastating

These treatments which have included oral medications, the use of vacuum devices and penile stretching exercises often destroy the elasticity of the penile tissue. Stretching exercises done on a daily basis can further damage the arterial blood flow. It's important to remember that to date, there are no safe or effective methods of increasing penis size. Internet claims are misleading, deceptive and dangerous. Treatments aimed at increasing the length of the penis could have the opposite results.

In conclusion, the field of sexual medicine today is driven by the pharmaceutical industry with the goal of making money. To date, billions of dollars have been made on sexual remedies by companies such as Pfizer, Bayer, Lilly-Icos and Mentor. These legitimate medications have greatly improved the sexual life of millions of people. With so much at stake, it is no wonder that generic medications, herbal supplements and Viagra copycats are relentless in their quest to cash in on the vulnerabilities of people with sexual dysfunction.

Experts agree that the stemming of unsafe products is going to be challenging at best. The source of contamination in these products may be difficult if not impossible to identify. Many of the raw materials for these supplements are purchased in bulk from Asia and developing countries. Often, government agencies do not pay strict attention to international patent laws governing the manufacturing of compounds such as PDE-5.

Purchasing sexual products on the internet has unique risks and potential dangers. It is critical to stay alert and to be an informed consumer. Clearly, using the internet for pharmaceuticals purchases demands that the "Buyer beware"!

1. Urological Times, Vol 32, No. 8, June 2004

For more information or for a consultation, Dr. Ducharme can be contacted at (617) 638-7358. His office is located at 720 Harrison Street, Suite 606, Boston, MA 02118.