Terra Sigillata

In an insult to dietary supplement companies who at least try to play by the rules, a company has agreed with the US FDA to recall its product because it might work too well:

FDA and Ebek, Inc. notified healthcare professionals and consumers of a voluntary nationwide recall of the company’s dietary supplement because the product contains tadalafil, a drug used to treat erectile dysfunction.

Yes, you read correctly: if the herbal product doesn’t work, just add an actual prescription drug to the concoction. Tadalafil is better known in the US as Cialis. In fact, this adulteration of herbal “libido booster” supplements has shown up in the literature a few times already.

This is not dissimilar to the case of an herbal agent promoted for the treatment of prostate cancer, PC-SPES, that was withdrawn from the market because it contained two active estrogens, complicating the interpretation of a clinical trial that had been ongoing with the supplement.

Adulteration with prescription drugs is one of the lesser-known risks of using herbal medicines in our current regulatory climate. Dr Edzard Ernst of the Department of Complementary Medicine at the University of Exeter reviewed this issue in 2002 and found one report where 24% of supplements in Taiwan contained at least one conventional drug.

While late-night comedians may have fun with this story, this tadalafil adulteration case does carry potentially serious consequences. From the FDA press release this afternoon:

Tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Consumers who have Liviro3 should stop using it immediately and contact their physician if they experience any problems that may be related to taking this product.

Comments

  1. #1 ukcommunitypharmacist
    January 25, 2007

    But natural = safe doesn’t it….

    And where did they get the tadalafil from in the first place?

  2. #2 Abel Pharmboy
    January 25, 2007

    With other adulterations, particularly of Asian herbs, I’ve heard the argument that pharmaceuticals and herbs are often processed on the same machinery and there is the possibility of slight cross-contamination if one isn’t following Good Manufacturing Practices. In this case, it sounds like there was an intentional addition of an amount of tadalafil to have a physiological effect.

    Where did the mfr get it? Probably the same place many Americans go for less expensive prescription drugs: Canada!

  3. #3 DuWayne
    January 25, 2007

    With other adulterations, particularly of Asian herbs, I’ve heard the argument that pharmaceuticals and herbs are often processed on the same machinery and there is the possibility of slight cross-contamination if one isn’t following Good Manufacturing Practices.

    But wouldn’t that mean that the pharmaceutial that gets mixed in with the herbal, is unlikely to be for the same ailment that the herbal is for? Or is that “normaly” how one finds these adulterations, with the pharma having nothing to do with the herbal?

    I am also curious, in relation to Asian herbals, are there a lot of them that are intentional adulterations? I have researched a couple and one was (can’t remember what it was called now). It is a really effective pain reliever – problem being that it contains something that is synthesized, and as far as I could find, not approved by the FDA. I decided that it just wasn’t worth the risk of taking things that come in packages I cannot read. It is a lot of work to track what is actually in them and too many, you can find nothing about.

    I actually prepare my own herbal supplements, from raw plants. I use very few preperations, one for pain, one for stress and one for sleep. Without any kind of regulation for their potency and production, I don’t trust many of the manufacturures of herbals. The easiest to trust are the ones that just put the powdered herb into a capsule, something I am capable of myself. When I make tinctures and extracts, I know how it is made and roughly how potent.

  4. #4 anjou
    January 25, 2007

    Catchy title!!

  5. #5 bcpmoon
    January 26, 2007

    The contamination argument doesn´t work. Even if you don´t work according to GMP, the amount of left-over API would not be significant. Detectable, of course, but not enough to have an effect. Moreover, more or less only the first batch would be contaminated. And I wonder what kind of equipment would be dual-use, most probably the one for formulation and not the actual synthesizing equipment and AFAIK those are mainly dedicated and so a cross-contamination is improbable. Plus the point made by DuWayne: If that was accidental, then it would be highly improbable that herb and API would be for the same ailment.
    No, its no accident, its deceiving and ripping off.
    BTW, if pharma would market a product with such a “contaminant”, there would be no voluntary action, it would be game over. Those guys are criminals.

  6. #6 Abel Pharmboy
    January 26, 2007

    bcpmoon, I never actually bought the ‘accidental’ manufacturing error argument either. There are published cases of adulterations of a product with more than one drug for more than one indication (i.e., obsolete anti-inflammatory phenylbutazone and the anxiolytic chlordiazepoxide).

    Agreed that this one is likely a deceiving ripoff and that there would be no such tolerance for pharma doing such a thing.

  7. #7 Joe
    January 26, 2007

    By what kind of rules do “supplement” manufacturers play? As I summarize the DSHEA “if you can put it in a tablet, capsule, or liquid and bottle it- you can sell it.” Those are not high standards. Comparing the ethics of companies that add active ingredients to those who don’t is like comparing ethics of pickpockets to three-card-monty dealers. True, adulteration is dangerous; but, the safety of supplements is usually unknown (as is the efficacy).

    Even when ephedra was known to be dangerous, it went on the market. The manufacturer followed the rules. People died while the FDA developed the data needed to ban it.

    APB, you know that the active ingredients of most “supplements” and herbs are unknown, so these products cannot be standardized and studied. Moreover, “traditional” uses may be irrelevant to actual drug activity. The upshot is, we gain useful facts by isolating and assaying active ingredients.

    I don’t understand why you stand-up for a quack industry.

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