FDA – Page 2 – The Finch and Pea

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”

When Supplements “Work”. . .Viagra, uh wait, I mean XXTreme

FDA notified consumers that lab analysis of lots of ejaculoid XXTREME and stimuloid II found that the products, sold as dietary supplements, contain sulfoaildenafil, similar to sildenafil, which is an active ingredient of an FDA-approved drug for male erectile dysfunction, making these products unapproved drugs. – FDA Medatch (emphasis added)

The drug has documented side effects from clinical trials and post-approval monitoring that is standard for pharmaceuticals. It also is not appropriate for people with certain other conditions, like high blood pressure, or in combination with other drugs, like nitroglycerin. These negative effects cannot be avoided if one does not know that this drug is in the supplement, especially considering that individuals for whom sildenafil (and analogs) is not a safe treatment are likely customers for these types of supplement. Continue reading “When Supplements “Work”. . .Viagra, uh wait, I mean XXTreme”

When Supplements “Work”. . .Joy Slim Recall

An herbal supplement for weight loss called Joy Slim, is being discontinued and recalled. Why? Because it contains sibutramine, an FDA regulated drug. Sibutramine, an appetite suppressant, is also used to treat obesity. There is no word on whether the FDA will take further disciplinary action against the manufacturer.

Continue reading “When Supplements “Work”. . .Joy Slim Recall”