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Tag Archives: FDA
When Supplements Work? “Sexual Health” dietary supplements like Viagra more than 60 year old investment bankers
The FDA has announced a voluntary recall of the “sexual health” (ie, erectile dysfunction) dietary supplement ACTRA-Sx 500 due to “adulteration” with the active compound from Viagra, sildenafil citrate. This is yet another recall of a “dietary supplement” that happens to be adulterated with a pharmaceutical that has been proven to treat the condition the supplement claims to address. This might make the supplement “work”, but it poses a real hazard to customers who are not permitted to know what they are taking. Continue reading
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
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
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