Healthy Skepticism Library item: 11039

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Product recall for herbal sex-enhancing product
The Age (Melbourne) 2007 Jul 30
http://www.theage.com.au/news/national/hard-sell-goes-awry/2007/07/30/1185647814135.html

Full text:

An herbal sex-enhancing product has been recalled after it was found to contain traces of a prescription-only erectile dysfunction drug that could pose serious health risks for men.

The national drug regulator issued a warning about Top Gun for Men Herbal Extracts pills when tests revealed it contained traces of the drug, tadalafil, which could have serious consequences for men with an existing heart condition.

The Therapeutic Goods Administration (TGA) said the product, which was available in NSW and Victoria, was not registered in Australia and had been supplied illegally.

Sold under the brand Cialis, tadalafil is commonly dubbed the “weekend erection” pill because of its potent effect.

A recall notice from Top Gun manufacturer, Sydney-based La Viva Blue, warned the product could have “serious health consequences, especially for patients with existing medical conditions such as heart problems, or persons at risk of stroke.”

“If you have Top Gun for Men, do not use it,” the company said in a statement.

A TGA spokeswoman said traces of the powerful undeclared additive were found during routine laboratory testing.

“Tadalafil is indicated for the treatment of erectile dysfunction in men and is available only on prescription from a registered medical practitioner due to the risks associated with its use,” she said.

“Consumers who have purchased Top Gun For Men are warned not to use it and to consult a medical practitioner if they have used the product and have concerns about their health.”

it was the second time this year herbal sex-enhancing products had been found to contain prescription-only chemicals.

In April, two other natural products, Excite for Women and Ultimates for Men, were found to contain the active ingredient in Viagra.

At the time, manufacturer Herbal Health International said the product had been “contaminated, but not by us”, and described the incident as “relatively minor”.

But David Henry, professor of clinical pharmacology at the University of Newcastle, today warned the active compound could be dangerous, and said buyers must beware when purchasing so-called “natural” products.

“The TGA does a pretty good job but it’s impossible to entirely eliminate products that make dubious therapeutic claims,” Prof Henry said.

“The onus rests heavily on the public to be very careful about what they purchase, put in their mouth and swallow.”

Pharmacist Geraldine Moses, who runs the Adverse Medicine Events line, said no complaints had yet been received about the herbal erection medication.