Marketers of non-alcohol-based consumer antiseptic products should be required to prove their products provide clinical benefit prior to sale, an FDA advisory panel unanimously agreed Oct. 20.

The Nonprescription Drugs Advisory Committee convened in Silver Spring, Md., to evaluate the efficacy and risks of antiseptic and antibacterial products marketed to consumers. Panel concerns centered on the potential relationship between biocides used in antibacterial products, such as triclosan and triclocarban, and antibiotic resistance.

"If you have unanswered questions about risk, benefit becomes more of a concern," Charles Ganley, MD, Director of FDA's Office of Nonprescription Products explained to the committee.

Without demonstrable benefit, a risk/benefit analysis "tilts to harm's side," James Omel, MD, the panel's patient representative noted.

While alcohol-based antiseptics are not hazard-free, their risks, such as dryness or adverse events due to overuse on infants, are known and could be remedied though labeling, the panelists largely agreed.

Stuart Levy, MD, Tufts University School of Medicine, presented an overview of research investigating a link between the use of biocides, including triclosan, triclocarban and benzalkonium chloride, and increased bacterial resistance. The microbiologist maintained that studies, when viewed in the light of the mechanics of resistance development, indicate that wide use of biocides likely would contribute to increased multi-drug resistance.

Levy, who is also president of the Alliance for the Prudent Use of Antibiotics, stressed: "My issue is not with the non-residue antibacterials."

However, biocides leave a residue on the skin after application, he stated. "Persistence is to me contrary to what I want because I see persistence as leading to resistance," Levy explained. Coupled with high consumer use, biocides' persistence presents a notable danger because "resistance evolves in time and volume of drug."

Thus, while short-term studies may not show a statistically significant difference between antibacterial and plain soap's effect on antibiotic resistance, the fact that antibacterial soaps lead to even a non-statistically significant increase is worrisome, he indicated.

For example, in a double-masked randomized study of 224 households conducted by Levy et al., researchers determined that use of liquid hand-soap containing 2% triclosan "did not lead to significant increase in anti-microbial drug resistance after one year."

However, the authors concluded that "further surveillance for the effect of long term use of triclosan might provide a suitable environment for emergence of resistant species," according to Levy.

In response to a question posed by FDA, the panel concurred that "systemic consequences for the individual user," such as antibacterial resistance in the individual, are a concern.

Concerns over data presented on human exposure to the biocides through secondary routes such as agriculture also contributed to the panel's decision to recommend FDA require benefit studies. Voting consultant Rolf Halden, PhD, Johns Hopkins Bloomberg School of Public Health, presented evidence to the panel that humans are being exposed to the biocides through food.

Industry representatives from the Soap & Detergent Association and the Cosmetic, Toiletry and Fragrance Association contended that the risks associated with biocides are only hypothetical and that "real-world" evidence is lacking.

While the panel exempted alcohol-based antiseptics from its risk/benefit discussion, they voted unanimously to affirm that consumer antiseptics should be proven to "provide clinical benefit by reducing infection."

Furthermore, the panel voted 11-1 that sufficient data had not been presented to support that "there are any populations, outside of the healthcare setting, in which consumer antiseptic use has been demonstrated to be more effective than use of plain soap in reducing infection rate." The vote was consistent with the conclusions of FDA reviewers (¹ [A#02260420012], p. 10).

However, NDAC members generally agreed that "there is a role for alcohol-based products in the absence of a faucet," such as an alcohol-based hand sanitizer like Pfizer's Purell .

- Katia Fowler & Melina Vissat

Non-Alcohol Antiseptic Hand Products Should Prove Efficacy – NDAC

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