August 25, 2010

By Brian Bujdos

The U.S. Food and Drug Administration (FDA) has recalled yet another sexual-related medication/supplement. This time it’s Masxtreme Capsules from Natural Wellness out of Deerfield Beach, Florida. The FDA stated that it found Aminotadalafil in the pills, which has some of the same components as Tadalafil, which is the active ingredient in the erectile dysfunction (ED) medication Levitra.

Masxtreme Capsules were marketed as a dietary supplement for improved sexual performance. Now, however, due to the presence of Tadalafil, Masxtreme is considered by the FDA to be “an unapproved new drug.”

As of the date of this recall, this webpage selling Masxtreme was still live. Among the many claims on the page is that “MasXtreme™ is 100% Natural. This was obviously not the case (especially for recalled lot number 907043 – the UPC is 094922300805).

Other claims included:

• Increased libido, stamina and energy
• A firmer, larger and longer-lasting erection
• No discomfort or uncomfortable side effects
• Enhanced sexual pleasure and peak sexual experience
• Increased desire, mood and endurance
• More powerful, long-lasting orgasms

That’s a pretty incredible (and now illegal) pill. All that from six (or seven) main ingredients: maca, long jack root (Tongkat Ali), catuaba, chuchuhuasi,  huanarpo macho, and evodia (and of course Tadalafil). Three of those herbs are from tree bark, two are roots and one is a fruit.

Another sex-related medication/supplement was recently recalled by the FDA – Mr. Magic Male Enhancer, which promised that it would make you “A Risin’ Star.” The FDA earlier this month found Mr. Magic wasn’t performing magic at all, it was giving its users a dose of Hydroxythiohomosildenafil and Sulfoaildenafil, which contain some of the same components as Sildenafil, the active ingredient in Viagra. The recalled lot numbers were 9041401, 251209 and 8121904.

The FDA has also recalled TimeOut sexual supplement because it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Any consumer who has TimeOut capsules should not take them because they can lower blood pressure if taken with certain other medications.

The moral of the story here is that no one oversees the manufacturing of supplements and non-FDA approved “medications” such as Mr. Magic. Therefore, these products contain UNKNOWN ingredients. There is simply no way to know for sure what is in the pills, capsules, tablets or what have you.

The Cleveland Plain Dealer, in a story published online yesterday, reported that one local Medical Center pharmacist tells his transplant patients to avoid supplements during treatment.

“You really aren’t sure what these people are getting,” he said. “There’s no regulation, so when you look at [a product] and it says there’s 700 milligrams of herb in it, you don’t really know if there’s 700, or if it’s 100, or 1,000. You don’t know if there’s fungus or yeast or bad bacteria in there. You don’t know if there are heavy metals like lead and zinc in them, because there’s actually no control.”

The FDA steps in only when there is a widespread problem with the effects of these medications, or when the organization finds there are prescription-only medications in the products – as was the case with Masxtreme and Mr. Magic.  It is recommended that if you purchase medications via the internet such as viagra online, be sure it comes from a trusted US site.

The presence of Sildenafil or Tadalafil (or their analog components) in medications means that these ingredients can have a harmful or fatal effect on patients who are unknowingly ingesting these ingredients. For instance, patients on nitrates or alpha blockers should never take FDA-approved erectile dysfunction medications because they could experience a serious drop in blood pressure.

In the current economy, everyone is looking to save a dollar and take a short cut. However, if we value our well being, one thing we should never skimp on is our health. Putting unknown ingredients in our mouth is one way to invite trouble.

Also read about the “Dirty Dozen” Dietary Supplements to Avoid, a recent article produced by Consumer Reports.

Read more health news articles on AccessRx.