Wednesday, January 18, 2006

"Immediate danger" with "natural" supplements...

...but not for the reason stated in this warning that I found in my snail-mail box from a large dietary supplement manufacturer .

Late Friday night, the US Food and Drug Administration (FDA) released a warning about two diet supplements imported from Brazil found to contain prescription drugs and an unapproved amphetamine. I wasn't going to write about this since I got tied up with working on a NIH grant this past weekend and, moreover, the story seems to have been beaten to death in the press and blogosphere. However, getting this mailer to contact my Congressional representatives to oppose legislation on adverse event reporting for dietary supplements just screamed for a response.

Without getting into the tedious issues of drug regulation, let it suffice to say that US dietary supplement manufacturers benefit from a 1994 law that allows them to market products without any proof of safety or effectiveness, so long as they don't make direct disease treatment claims on the labels. In fact, the US FDA can only step in and remove a product from the market if reports accumulate that it is unsafe. Currently, most such reports come from poison control centers meaning that there have to be injuries or even deaths before unsafe supplements can be taken off the shelves.

In this case, the reports likely stemmed from a consumer getting an unexpected positive drug screen result for amphetamine. Samples from the products in question, Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement, were found to contain chlordiazepoxide HCl (the active component of the original anxiolytic benzodiazepine, Librium) and fluoxetine HCl (the active component of the serotonin-selective reuptake inhibitor antidepressant, Prozac). So where was the amphetamine? Well, some samples were also found to contain Fenoproporex (N-2-cyanoethylamphetamine), that is converted in the body to amphetamine. Incidentally, it is apparently used commonly by Brazilian truck drivers to stay awake. Hell, why take NoDoz when you can get an amphetamine prodrug?

This adulteration of herbal supplements with prescription drugs occurs almost exclusively with supplements imported from Asia and South America. Generally, these are probably accidents of poor manufacturing practices. Many generic drug manufacturers outside the US also make herbal formulations and there is a good chance of carryover of the previous batch into some of the herbal product. That may explain the presence of fluoxetine and chlordiazepoxide, both of which are currently available in generic forms.

Of course, it's tough to say whether the addition of these two compounds could be intentional on the part of the manufacturer. Benzodiazepines like chlordiazepoxide can cause weight loss, perhaps by reducing anxiety associated with hunger when dieting. But they could equally cause weight gain by making one feel too sedated to exercise. Not surprisingly, most benzodiazepine package inserts note "weight gain or loss" as potential side effects. The inclusion of fluoxetine could be accidental or a misinterpretation of reports that other SSRIs like Meridia are used for weight loss; bad idea to put fluoxetine in there because it is more commonly associated with weight gain. Again, package inserts for SSRI antidepressants indicate the risk of either weight loss or gain. However, the presence of the amphetamine compound is the most likely indication of an intentional addition since amphetamines are well-known appetite-suppressants (also known as 'anorectics'), no doubt about it.

But I digress...

Why, as detailed in the mailer above, would a US herbal manufacturer oppose legislation that would improve the safety of botanicals they sell to their patients...I mean, consumers? Saying that Big Pharma is behind this is lame. US sales of individual herbal remedies is only in the hundreds of millions of dollars for big sellers like Echinacea, but those numbers are usually the sum of products from dozens of manufacturers. Big Pharma has gotten involved mildly in herbal products, usually under their consumer products divisions, as with Remifemin brand of black cohosh (GlaxoSmithKline, until recently). Correct me if I am wrong Pharma readers, but big companies won't get interested until herbs start selling several billions of dollars per year.

I'm equally stunned by this mailer since herbal trade organizations and some of the bigger manufacturers are actually in favor of a monitoring system for herb safety. I attended a botanical safety conference at the University of Minnesota almost two years ago where I head Michael McGuffin, president of the American Herbal Products Association (AHPA), welcome an adverse event reporting system so as to show once and for all that herbal supplements are far safer than prescription drugs. (This may be factual and/or due to the fact that many herbal products lack either sufficient levels of pharmacologically-active constituents or adequate bioavailability of these compounds.). Moreover, larger herbal manufacturers have been hurt by the unscrupulous practices of some of the smaller companies who have less means for authoritative botanical quality control and other good manufacturing practices. However, I sense that all might still prefer the current state of self-regulation, creating a medicinal double-standard in this country.

But the herbal industry has done well with scare tactics that depict any proposed regulatory guidelines as the government's attempt to undermine your rights and freedoms to take vitamins and supplements. The watered-down 1994 legislation that allows herbs to be sold in the US under such relaxed quality and safety restrictions was the results of a similar letter-writing campaign.

I'm certainly not a big fan of more government, particularly since our own FDA has taken a good deal of heat as of late for prescription drug regulation. I just think that there is ample precedent for herbs to be regulated in a manner that is not as extensive as that for prescription drugs, but with improved assurances for quality and safety, particularly for warnings of potential interactions with precription drugs the consumer may also be taking Canada's Natural Health Products Directorate is an ideal place to start, but I can tell that I'm already losing you with talking about regulations.

Take home message: Just because a supplement bottle has great graphics and is often sold side-by-side with over-the-counter drugs, the content, effectiveness, and safety of such products is a crapshoot.


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