The Universe is a funny place, full of bizarre coincidences. What are the odds that a dietary supplement would, by chance, contain a regulated drug that treats exactly the same condition that the supplement claims to treat?

This week we get a double whammy from EZVille, Ltd. EZVille, Ltd. has issued a recall of Revivexxx (one guess what that is supposed to "revive") and Solo Slim. Revivexxx is a male sexual enhancement supplement (DSHEA code for treating erectile dysfunction), which was found to contain the erectile dysfunction pharmaceutical tadalafil (marketed using a series of creepy commericals under the brand name Cialis). Tadalafil is known to have potentially dangerous interactions with medications containing nitrates, such as those taken for heart disease. Solo Slim is a weight loss supplement, which was found to contain the appetite suppressant didesmethyl sibutramine. Sibutramine can increase blood pressure and heart rate putting individuals at risk for stroke and other cardiovascular issues at greater risk.

Individuals for whom tadalafil and sibutramine are not viable therapeutic options due to interacting medications or underlying medical issues may be more likely to seek out these alternative products to avoid side effects. The undeclared presence of these drugs in these supplements exposes these "at risk" individuals to these potentially dangerous side effects without their knowledge, unarguably a worse situation than if they had knowingly been prescribed these medications under the observation of a trained health care professional.

On 6 August 2010, EZVille, Ltd. issued two press releases (Revivexxx and Solo Slim) announcing the recalls. Despite the safety implications of these undeclared drug ingredients, the EZVille, Ltd. websites present no information about the undeclared drug ingredients or the recall (screen capture images are at the bottom of the post). Instead, there seems to be less information available than before. The text of an email sent to EZVille, Ltd. inquiring about their efforts to inform customers of this important health issue is below.
TO: Eric Budnzinski (ericb@ezville.com)

SUBJECT: Information on Revivexxx and Solo Slim Recalls

Dear Mr. Budzinski,

As a concerned parent and consumer, I subscribe to the US Food&Drug Administration's MedWatch service and was distressed to see that EZVille, Ltd. is issuing voluntary recalls for two of its products (Revivexxx and Solo Slim) due to the presence of undeclared drug ingredients (tadalafil and didesmethyl sibutramine).

I am sure that you are aware that these drugs can have potentially dangerous side effects for individuals with particular health conditions or who are taking other medications with which these drugs might have negative interactions (such as nitrates with tadalafil). Due to these side effects and drug interactions, individuals with these condition or on such medications may be more likely to seek out alternative treatments for conditions, like erectile dysfunction and weight loss, to avoid the effects caused by the very drugs that have been found in EZVille, Ltd's products.

Given EZVille, Ltd's laudable concern for the health and safety of its customers:

"EZVille, Ltd. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers."
I am curious about the lack of information about these recalls or the detection of these drugs in EZVille, Ltd's products on either the EZVille, Ltd website or the individual product websites. Revivexxx pages are empty or state "there are no products to list in this category". The Solo Slim website makes no mention of a recall or drug ingredients, except to mention that the product is not currently available without explanation. I will be happy to provide screen capture images of the relevant sites, if this would be helpful.

Where would a consumer who does not subscribe to the FDA MedWatch emails learn about this recall? Have consumers who made internet purchases been contacted? How are you contacting consumers that purchased these products in stores?

The press release is dated 6 August 2010. It is now 10 August 2010. While some alterations have been made to EZVille, Ltd websites, these changes do not inform consumers about the recall or the issues involved in the recall. For an issue that affects "the health and safety of consumers", the lack of positive action to inform current and potential customers of this situation suggests that EZVille, Ltd may not be sufficiently concerned with "the health and safety of consumers".

Sincerely,
Josh Witten
 


 

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*Front page image by rodrigo senna (CC 2.0)