FDA: Consumer Warning for Male Sexual Enhancement Supplement

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for Super Power, a supplement for male sexual enhancement.

Manufactured by Freedom Trading, laboratory tests showed that Super Power, which was falsely marketed as a supplement, contained sildenafil, making it an unapproved drug. Sildenafil is a main ingredient in erectile dysfunction drugs.

An interaction between sildenafil and prescription drugs containing nitrates (such as nitroglycerin) may lower blood pressure to an unsafe level. Individuals taking nitrates often have diabetes, high blood pressure or cholesterol, or heart disease.

Freedom Trading has recalled one lot of Super Power.

Any consumer in possession of lot number L08108 of Super Power should discard the product immediately. Individuals taking Super Power should report any negative side effects to their healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information about integrative therapies for erectile dysfunction, please visit Natural Standard's Comparative Effectiveness database.

Comments

[MS]

It is scary to see medications such as super power be freely distributed without having enough laboratory tests performed before being accessible to the general population. Sildenafil should not be taken with drugs containing nitrates. Although sildenafil is contraindicated to be taken with nitrates if it has been less than 24 hours since the last does of sildenafil. When sildenafil is taken with nitrates it potentiates the hypotensive effect.

[ac]

I feel as if I see this story on the Natural Standard blog every week: FDA says that X supplement does not contain what it says it contains. There is obviously an element of common sense that a consumer must have when deciding to purchase a product called "super power" - the name itself leads me to doubt it's credibility. Even with these "FDA Alerts" posted, I imagine that the message does not often get to the consumer. How many consumers typically read FDA reports?

[km]

Super Power, like many other male sexual enhancement supplements on the market, contains ingredients that are not fully tested and regulated by the FDA. Sildenafil is the main active ingredient for Viagra, which is widely used to treat sexual dysfunction. Since Super Power contains sidenafil, the risk of patient with history of cardiovascular disease taking this supplement without knowing it is indeed very high. These groups of people also tend to take male sexual enhancement supplements as well. This lack of information can lead to severe complications, especially in the population who are currently taking nitrates and other antihypertensive medications.

[AR]

I was interested to see if the FDA's website had anymore information on the topic of tainted sexual enhancement products. I found that the FDA reported that in Februray 2012 a product called "Man King," which is also used for sexual enhancement, was found to contain sildenafil too, and in May 2012 a different sexual enhancement supplement, called “EreXite,” was found to contain tadalafil, which is a main ingredient in a different drug used to treat erectile dysfunction. Why do these supplements, like "Super Power," keep trying to sneak drugs into their products? Do they not realize that they could harm or kill someone?

[kl]

This should be a lesson to people. 1. Natural herbs and supplements are unregulated. 2. Any company or individual can produce a "natural" product, suggest it's a "super power", and market it to the general public. 3. The FDA must prove that these herbs and supplements are unsafe before they are removed from the market. As we see here, dietary herbs and supplements are not always safe because they are considered "natural" and in fact may cause serious adverse effects or interact with other medications. For this reason, it is always important to discuss any natural supplements you are taking with your doctor and always be on the lookout for the "quick-fix" dietary herb or supplement because odds are, it's not a "quick-fix".

[bz]

It is interesting to see the frequency of these issues increasing. It seems like every other week there is another report of a supplement containing prescription drug products. This is always a dangerous situation, as prescription drugs are regulated with prescriptions for a reason - they are not for everyone! Again, I think this clearly needs more federal oversight to prevent this type of error from occurring!

[bz]

It is interesting to see the frequency of these issues increasing. It seems like every other week there is another report of a supplement containing prescription drug products. This is always a dangerous situation, as prescription drugs are regulated with prescriptions for a reason - they are not for everyone! Again, I think this clearly needs more federal oversight to prevent this type of error from occurring!