Opinions on Enzyte, Avlimil,...

[28657]

I'm wondering what other pharmacy students or pharmacists think about certain new non-prescription medications. I just saw a TV ad for a drug called Altovis and even though it's really good at looking highly professional (i.e. LOTS of money spent on packaging, advertising, marketing) I had a feeling it was made by the same company that makes Enzyte and Avlimil. So I googled it and found out that all of these drugs are made by Berkeley Premium Nutraceuticals.

For some reason I have a problem with how they present their product, and I think a lot of consumers don't/won't understand that these drugs aren't FDA approved. I wouldn't be surprised if in the near future the advertising method becomes a concern by the FDA, itself. Even the FTC has jumped on saying that ?If the product being pitched to cure impotence is "herbal" or "all natural," dismiss it.?

So my question is, do you think there's a proper role for these kinds of drugs in the scheme of things, or do you think it's a dangerous/ineffective/expensive mean to treat ailments?

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[Shanana]

It's snake oil

"Nutraceuticals" - what a joke

 

[dgroulx]

According to the FDA, herbal products are not allowed to make claims. They can only "suggest" where it may help. Obviously, the makers of herbal products chose this path because the FDA would make them prove safety and efficacy.

I try to educate people when I can. When counseling, we just need to make sure not to offend the people by telling them that their culture is invalid. Lots of people believe in herbal remedies. Some may work to some extent, but without controls, you don't know what you are getting.

 

[28657]

Well I don't quite understand the line between claims and suggestions.
There's a class action lawsuit against Enzyte for false claims and deceptive advertising. Apparently before the lawsuit, the product claimed things such as:
-- "100% Safe with a 98.3% Success Rate"
-- " ... your erectile chambers, as well as your penis, will enlarge up to
41%"

I agree that pharmacists need to be culturally sensitive to patients who believe in herbal pharmaceuticals, however, I don't believe these products are a "cultural" issue.

 

[jdpharmd?]

According to the FDA, herbal products are not allowed to make claims. They can only "suggest" where it may help. Obviously, the makers of herbal products chose this path because the FDA would make them prove safety and efficacy.

They definately do more than "suggest" that they work. The commercials say things like "he knows how to 'get wood'" or "he's learned a little well-earned respect from the neighborhood". While those don't DIRECTLY make claims, they are pretty much the same thing, especially when they show the neighbors staring at his crotch when he gets out of the pool (in the ad).

This is directly off their website:

"Here you will discover answers to many of the frequently asked questions about Enzyte, a simple step you can take today to help improve the quality of your erections.

And the disclaimer at the bottom that nobody reads or understands

*These statements have not been reviewed by the Food and Drug Administration, and individual results may vary. Enzyte should be taken as part of a healthy lifestyle and is not intended to diagnose, treat, cure, or prevent any disease.

"Enzyte SHOULD be taken as part of a health lifestyle"??? WTF? I have to take enzyte to be healthy?

"...Enzyte, a simple step that you can take today to help improve the quality of your erections." That is a 'claim' if I've ever heard one. I wish I could get a cut of this company's profit!

The ingredients secion of their site says something about "Thymus Gland". It REALLY looks like it CONTAINS pieces of thymus gland, but I wonder if they are claiming that it helps with thymus gland health??

 

[jdpharmd?]

Here is another one off of Enzyte's website:

"I'm not old enough to need a prescription...."

I also like how they cite "The PDR for herbal medication" for substantiation, since the PDR is funded by drug companies. I wonder who the HERBAL PDR is funded by?? Hmmm, herbal drug producers??

 

[LVPharm]

These are some of the "slickest" commercials I've ever seen for a so-called "nutraceutical". Everything about it..from those relatively "high production value" commercials to their website make it seem as though this is a legitimate FDA regulated pharmaceutical product. Enzyte also sponsors a NASCAR stock car...just like Viagra does. They used to show the "Enzyte" emblem with the name of the herbal written underneath it...very similar to what you would see with other pharmaceuticals (like "Viagra", with "sildenafil citrate" written underneath it in small font). The average consumer may not be able to distinguish (at least initially) between Enzyte, and other real medications used in the treatment of erectile dysfunction.

So, even if they don't make any overt and outright "claims" as to the efficacy of their so-called "proprietary blend", their entire marketing scheme is aimed at making it a legitimate "Viagra-like" drug.

 

[LVPharm]

So my question is, do you think there's a proper role for these kinds of drugs in the scheme of things, or do you think it's a dangerous/ineffective/expensive mean to treat ailments?

Let's look at one of the ingredients. Literature proving the efficacy of Yohimbe, which is part of the proprietary blend, is scant at best.

It's also replete with its own set of contraindications and possible drug-drug and drug-food interactions. Because it has the potential to raise blood pressure and cause tachycardia, people with HTN should not take it regularly (or at all). People with renal or hepatic insufficiency should not take it. Because part of yohimbe's mechanism of action is as a monoamine oxidase inhibitor, someone taking this regularly may have to be careful about tyramine containing foods like cheese and wine. There may be some drug interaction with patients taking TCA's like desipramine and clomipramine. Just because this thing is sold without a prescription does not make it totally safe (to say the least, look at ephedra until recently, or even St. John's Wort). It's most probably just ineffective, but can cause problems of its own, especially if taken as directed by the manufacturer: QD. Think about the segment of the population who does suffer from ED...they do tend to be people with HTN.

Don't get me wrong here, some herbal products do have a place in therapy. St. John's Wort can be effectively used in the treatment of mild depression, and has been used for years in Europe in that capacity, but St. John's Wort is also an inducer of the CYP450 3A4 subsystem. If I was using Tegretol to control my seizures, I may have a seizure because SJW cut my Tegretol's effectiveness by 50%. My problem with any of these preparations has to do with the lack of information given to patients about the potential for health problems arising from taking them.

 

[Dr JPH]

Yohimbe is not the same as Yohimbine. The former has been shown to inhibit MAO, but the latter (although derived from Yohimbe) has not been shown to exhibit this property but rather works as an alpha-2 adrenergic antagonist. (helps you point and delays the shoot)

 

[Dr JPH]

But in response to the initial post, I think it is irresponsible to peddle these products to the general public as 90% of them are laypersons and would buy my old roomates' urine soaked mattress if I had the right spokesperson or a catchy jingle.

As healthcare professionals we will be the ones sorting through all of these issues and trying to educate people on the dangers of mixing these "herbals" with their current prescription therapy, not to mention there other intakes...nicotine, etoh, diet, "illicits", etc.

When I'm a doctor I'm going to make sure I educate my pts on these sorts of products.

Just as non-prescription does not equal low potencty, natural does not equal safe. Unfortunately you and I know that...but everyone else doesn't.

 

[28657]

Yohimbe is not the same as Yohimbine. The former has been shown to inhibit MAO, but the latter (although derived from Yohimbe) has not been shown to exhibit this property but rather works as an alpha-2 adrenergic antagonist. (helps you point and delays the shoot)

JP, I'm a little confused - LVPharm was speaking about Yohimbe, the ingredient in Enzyte, which is a monoamine oxidase inhibitor. Not sure what you mean by the yohimbine comments?

 

[LVPharm]

When I'm a doctor I'm going to make sure I educate my pts on these sorts of products.

Just as non-prescription does not equal low potencty, natural does not equal safe. Unfortunately you and I know that...but everyone else doesn't.

Here here! Most people do not appreciate that just because it's herbal and readilly available does not make it safe. They do exhibit pharmacology, they are drugs, and can cause the same kinds of problems other Rx and OTC drugs can cause...interactions, side effects, etc.

 

[Dr JPH]

JP, I'm a little confused - LVPharm was speaking about Yohimbe, the ingredient in Enzyte, which is a monoamine oxidase inhibitor. Not sure what you mean by the yohimbine comments?

If I recall correctly, Enzyte has Yohimbe extract. As to the amount and whether or not the yohimbe itself is there in its full (MAO inhibiting) potency is unclear as the FDA has no govern over the quality control of the product. I think the product actually contains Yohimbine, the active ingredient in the bark itself that acts on the above described mechanism. But after fully reviewing the literature that they provide on their website (the 217 page ingredient substantiation PDF) it's really unclear as to WHAT the hell they put in there.

In fact, their literature states that YohimbINE acts as an MAOI, which is false.

I wouldn't recommend this product to ANYONE.

I recall the case study of a psych pt who overdosed on his Parnate and decided to have his own private wine and cheese party to celebrate his impending death by suicide. Not nice what happens to your body in that case.

 

[LVPharm]

"The Once-A-Day Tablet for Natural Male Enhancement"

Natural male enhancement? If you didn't read their claims and went by that, you'd think that this stuff makes your junk bigger! Just like all that spam I get in my email...