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Hong Kong experts warn against anti-impotence "remedies"
By Tan Ee Lyn Thursday, Oct. 11, 2007;
2:27 PM
HONG KONG (Reuters) - Researchers have warned about "herbal
remedies" for erectile dysfunction sold over-the-counter in Hong Kong after
most of them were found to contain untested variants of well-known
anti-impotence drugs.
These variants, or "analogues", are copies of controlled drugs but they
are slightly modified in their chemical structure to escape patent and other
drug-related laws.
Cranked out illegally, these chemicals are not tested for their efficacy
or safety and can have unpredictable, adverse effects. They are added
undeclared into "health products", which do not come under stringent tests
in most countries.
Writing in the latest issue of the Hong Kong Medical Journal, the
scientists said they studied 26 anti-impotence products sold in convenience
stores and pharmacies.
Although their packaging declared that they contained only "herbal
ingredients", variants of sildenafil and vardenafil were found in 14 of
them. Sildenafil was found in one product.
Sildenafil and vardenafil are generic names for their better known trade
labels Viagra and Levitra, respectively, and they are prescribed drugs in
Hong Kong.
"The positive rate of concealed drug analogues in male erectile
dysfunction health products is alarmingly high. Such analogues are difficult
to detect by ordinary laboratory methods and might be used in an attempt to
evade regulatory inspection," wrote the researchers at the Hospital
Authority Toxicology Reference Laboratory in the journal's October issue.
"Without going through the stringent drug testing process, the adverse
effects of these chemicals remain largely unknown and unpredictable," they
warned, as they called for urgent and more effective surveillance and
control.
"The medical profession and the public should be alerted to this
under-recognized threat."
This malpractice came to light when a previously healthy 28-year-old man
got admitted to hospital for an unsteady gait and frequent falls -- signs of
ataxia.
Doctors then learnt that he had taken an anti-impotence "health product"
for over a week before showing those symptoms.
Classified as phosphodiesterase-5 inhibitors, sildenafil and vardenafil
are known to have side-effects like nausea, headache, facial flushing and
visual disturbances. Serious cardiovascular effects have also been reported.
But ataxia has never been linked to this class of drugs.
"Unlike the parent pharmaceutical, no formal studies have been performed
to assure the safety and efficacy of these analogues," the researchers
wrote.
"Evidently, the adverse effects of drug analogues are highly
unpredictable and the consumption of such products is dangerous.
Contamination of herbal products with
prescription medications is an extraordinarily deadly scam.
In the present case, drugs for erectile dysfunction (ED)
apparently were deliberately mixed with various almost
useless herbs. This deliberate adulteration has two obvious
potential effects. First, the prescription drug can increase
the effect and mislead the user into thinking that the herbs
did work. Secondly, there's a risk of side effects
(including death) if the patient has been taking other drugs
that interact with prescription ED drugs and/or has medical
conditions that preclude the use of ED drugs.
Anyone considering ordering "Herbal Viagra" or similar
products should be aware of this deceptive practice.
As of 13May2004, there are about 172,000 webpages at
Google found by searching for webpages containing the phrase
"herbal
viagra." ----Posted on diabetesmonitor.com
From Reuters: (1)
"Herbal" Viagra and other so-called natural alternatives
for treating impotence advertised on the Internet and in men's
magazines are often contaminated with real drugs and could
kill those who take them, researchers said on Monday…
Fleshner and colleagues bought seven "herbal" erectile
dysfunction products to find out what was in them. Two
contained significant levels of prescription phosphodiesterase
inhibitors -- sildenafil, sold by Pfizer under the brand name
Viagra and tadalafil, Eli Lilly and Co's Cialis.
"We think the implications of this are quite dramatic,"
Fleshner told a news conference. "Since these compounds are
not natural, deliberate contamination of these products must
be considered," added Fleshner, whose team presented the
findings to a meeting of the American Urological Association
in San Francisco.
The erectile dysfunction drugs affect blood flow and can be
deadly when taken with certain heart drugs containing
nitrates.
From the abstract of the report (2)
We set out to determine if marketed herbal preparations for
the treatment of ED contained PDE5 inhibitors [phosphodiesterase
(PDE5) inhibitors include Viagra, Cialis, and Levitra].
Methods: We purchased seven brands of marketed herbal products
for the treatment of ED. Purchases were limited to oral
tablets or capsules that claimed to improve erection quality
if consumed prior to sexual activity…
Results: Significant contamination with sildenafil and
tadalafil was detected in two out of 7 of the herbal
preparations examined…
Conclusions: Since PDE5 inhibitors are not natural,
deliberate contamination of these products must be considered.
Consumers and regulatory agencies must be aware of these
findings as these agents have known fatal interactions with
prevalently consumed drugs (e.g. nitrates). These findings
also seriously challenge the concept of safety of CAM agents. |
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