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Antibacterial Soap Latest on FDA’s Hit List

Washing HandsThe Washington Post recently published an article showing how an antibacterial chemical in soap is now on FDA’s hit list. The FDA is reportedly going to require that manufacturers prove antibacterial soaps are safe and more effective than regular soap and water.

The problem that I had with the FDA’s request for more research to prove the safety and efficacy of triclosan, the ingredient under scrutiny, was that a PubMed search shows 1915 articles using the keyword “triclosan”. What more research does the CDC want?

According to an FDA Consumer Update triclosan has “altered hormone regulation” in animals and other studies [not cited in the FDA update] have “raised the possibility” that the chemical may make bacteria resistant to antibiotics.

First of all, I’m not going to take sides on whether using antimicrobial soap is always a good or bad thing. Personally, I think that using it under circumstances where there is greater risk for transmission of disease is appropriate. Cutting up raw chicken? Use antibacterial soap afterwards. Changing a diaper full of foul-smelling diarrhea? Ditto. Hospital patient contact? Maybe. ICU patients? Probably. Post op patients? Yes. To me, it ends up being a judgment call. If there’s no harm in using it, what’s the problem?

So let’s look at some data.

Research Already Shows Triclosan is Safe and Effective

Below are just a smattering of the studies I found demonstrating the safety and effectiveness of triclosan. Remember that triclosan has been approved for use since 1972.

Claims That Triclosan “Alters Hormone Regulation” Are Speculative

Triclosan is somewhat structurally similar to thyroid hormones. The theory is that using triclosan would cause the body to shut down its thyroid hormone production, causing “altered hormone regulation.”
If you’re a North American bullfrog, triclosan may be a problem. This study showed that triclosan altered thryroid hormone receptor expression in premetamorphic tadpoles.
Off of the lilypad, when people used .3% triclosan toothpaste for 4 years, researchers did find a significant decrease in the free thyroxine levels at the end of five years … in the control subjects who weren’t using the triclosan. In other words, using triclosan was associated with protected thyroxine levels and hormone regulation, not altered hormone regulation.

Claims That Triclosan May Cause Antibiotic Resistance Don’t Hold Water

A couple of studies showed that there wasn’t any relationship between triclosan use and antibiotic resistance.

 Additional Triclosan Articles

Then there was this 2007 article noting that soaps using triclosan concentrations between .1% and .45% were not any more effective than plain soap at preventing infectious illnesses or at reducing bacterial levels on the hands. The article concluded that

The lack of an additional health benefit associated with the use of triclosan-containing consumer soaps over regular soap, coupled with laboratory data demonstrating a potential risk of selecting for drug resistance, warrants further evaluation by governmental regulators regarding antibacterial product claims and advertising

Nary a year later, there was this letter to the editor of the Journal of Antimicrobial Chemotherapy showing how when another disinfectant called benzalkonium chloride was used along with low-concentration triclosan, that there was a higher resistance to both benzalkonium and triclosan. However, the data wasn’t clear and it lumped together all the different bacteria studied instead of reporting on each of the antimicrobials and bacteria separately.

Both of the above articles and the 2004 article showing a “nonsignificant trend” toward antibiotic resistance had two common authors, Stuart Levy and Elaine Larson.

Stuart Levy and his pharmaceutical company Paratek Pharmaceuticals recently published a couple of articles on a new tetracycline-based antibiotic called Omadacycline. Now this is an oral antibiotic and not a topical disinfectant, so there’s no overt conflict of interest.

But is there a “nonsignificant trend” toward a conflict?

So I began to wonder …
Why is the FDA just now giving us a “Consumer Update” on an issue raised in 2007?
What studies does the FDA have to bolster its assertions and why isn’t the FDA releasing those studies?
Why are two authors publishing multiple articles whose aim appears to be removing topical antimicrobials from hand sanitizers when many studies show that there is a benefit to having those antimicrobials present?

Do you use antibacterial soap?

What do you think about the FDA’s investigation?

Here are some additional articles about the FDA’s issues with triclosan
ABC News: Popular Antibacterial Soap Ingredient Draws FDA Scrutiny
Fox News: FDA to decide if common chemical in antibacterial soap is safe
NY Times: Antibacterial Chemical Raises Safety Issues

One comment

  1. We use Softsoap advanced clean Hand Soap with moisturizer. The front label states, “Wash Away Bacteria*”; with the note on the back label stating, “*Wash away dirt & bacteria for good hand hygiene.”

    I don’t see any triclosan in the Ingredient list, (unless it is hiding under an alternate name.)

    Ingredients: water, sodium laureth sulfate, cocamiddopropyl betaine, decyl glucoside, sodium chloride, fragrance, DMDM hydantoin, polyquaternium-7, tetrasodium EDTA, citric acid, sodium sulfate, PEG-120 methyl glucose dioleate, PEG-7 glyceryl cocoate, poloxamer124, D&C red No. 33, FD&C blue No. 1

    _____________________

    Does anyone remember Phisohex? It used to be available OTC.

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