RegenArouse (When Supplements Work?)

Real drugs, with real physiological activities, have very real side effects. As a result, some drugs cannot be safely taken by some individuals with underlying conditions or who are taking other, incompatible medications. When “nutritional supplements” contain undisclosed drugs, potentially dangerous side effects and interactions cannot be avoided.  Individuals that cannot take a drug due to underlying risk factors may be more likely to be customers for these alternative treatments, placing them at even greater risk. To err is human. To have an undeclared drug in your supplement that happens to cause the same therapeutic effects claimed for your supplement is anything but divine.

The latest supplement to run afoul of the FDA’s “if you product contains a drug, it is a drug” rule is RegenArouse, a supplement for erectile disfunction, which was found to contain tadalafil. Continue reading “RegenArouse (When Supplements Work?)”

X-Hero and Male Enhancer (When supplements “work X)

Shockingly, two “dietary supplements” for male enhancement have been found to contain active ingredients that happen to treat erectile dysfunction. Effectively, these products are unannounced and unregulated versions of Viagra (X-Hero) and Cialis (Male Enhancer), both of which have risks of negative interactions with other drugs. These interactions can only be avoided if individuals are aware that they are being exposed.

FDA lab analysis of X-Hero found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug. In addition, FDA analysis of Male Enhancer sample found the product contains tadalafil, the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Male Enhancer an unapproved drug.

The products pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance.

FDA Medwatch (emphasis added)

When Supplements “Work”. . .Light Headed, for the Wrong Reasons

Let’s say you have diabetes or heart disease and are taking nitrates for your condition. And, unfortunately, maybe you need a little more lead in your pencil, which is even more common with some of these conditions. Well your doctor might hesitate to prescribe the most common pharmaceuticals for erectile dysfunction, like tadalafil (Cialis) or sildenafil (Viagra), because these drugs taken in combination with nitrates can cause dangerously low blood pressure. So, in your desperation, you might think about reaching for one of those sexual enhancement supplements about which we all get countless emails. Continue reading “When Supplements “Work”. . .Light Headed, for the Wrong Reasons”

When Supplements “Work”. . .EZVille, Ltd – Where Health & Safety are Important-ish

The Universe is a funny place, full of bizarre coincidences. Like, for example, did you know that every single “dietary supplement” with an undeclared drug ingredient that we have covered in our When Supplements “Work”. . . feature so far has contained, among all the drugs in the world, a regulated drug that treats exactly the same condition that the supplement claims to treat? What are the odds?

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. Continue reading “When Supplements “Work”. . .EZVille, Ltd – Where Health & Safety are Important-ish”