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
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
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
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
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
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.
© Stanley Ducharme, Ph.D.