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Executive Summary

DEXIDE ULTRADEX (CHLOROXYLENOL) EPIDEMIOLOGICAL REVIEW of a specific population such as nurses could be used to support the safety of the surgical scrub for long-term use in the general population. The epidemiological study was suggested by FDA Office of Biologics Research & Review Assistant Director of Pharmacology and Toxicology Judith Weissinger, PhD, at a Sept. 17 OTC feedback meeting. Weissinger noted that FDA would like data to "satisfy our basic concern which is . . . these nurses are using this five times a day for 10 to 15 [years] and nobody has ever checked." Weissinger stated that such a epidemiologic study would address FDA's ongoing concern that chloroxylenol or PCMX may have the potential to accumulate in the body and cause toxicity. "You can write up a questionnaire [for] people using it daily, a number of users, and give their entire medical history . . . that's a 10-year history . . . so you can get that kind of questionnaire and an epidemiology study. Certainly post-human use safety is a very valuable part of what has got to be" a well-designed and controlled study, Weissinger told the company. In separate reviews of chloroxylenol, the OTC Antimicrobial I and II Panels recommended that chloroxylenol be placed in Category III, as a surgical scrub. The Antimicrobial II Panel placed PCMX in Category I for safety when used as a topical antifungal agent. Dexide and Ferro Corp have petitioned FDA to upgrade the ingredient's classification in the OTC Antimicrobial Tentative Final Monograph from Category III to Category I. A summary report was presented by Dexide consultant Wallace Guess, PhD, University of Mississippi, reviewing the data on chloroxylenol already submitted to FDA. Guess told Weissinger and FDA Division of Anti-Infective Drug Products toxicologist John Davitt that "we have no new submissions" and "that we admit right up front that there are holes in the database and there have been from Day One and the data base really hasn't changed significantly since 1977." The review of the chloroxylenol data was co-authored by Guess and former FDAer Mary Bruch. Guess was previously a chairman of one of FDA's OTC Review panels. The summary report, called "A Review of Available Toxicity Data on the Topical Antimicrobial, Chloroxylenol," was published in the Journal of Toxicology: Cutaneous and Ocular Toxicology. FDA's continuing position is that the data submitted are inadequate to support chloroxylenol's safety for chronic use as a surgical scrub. The agency had earlier suggested that a two-year rat study was needed in order to assess the long-term effects of the antimicrobial agent ("The Pink Sheet" Feb. 17, 1986, T&G-8). At the feedback meeting, Weissinger asked Dexide why it did not conduct the two-year study and maintained that a long-term low dose study is necessary. "I have seen too many instances where long-term low dose could not be predicted on a short-term basis, unless the dose could be higher," Weissinger said. Dexide continues to assert that long-term studies are not necessary and that subchronic accumulation studies including its computer simulation model support the firm's position that chloroxylenol does not have the potential for accumulation or toxicity. Guess stated that the firm has asked FDA to define the problem with existing data. "Primarily the answer comes back, we want you to do a two-year study. For what reason is not clear, because if you look at the data base and look at the problem of accumulation or lack of accumulation and look at the short-term toxicity and long-term toxicity studies there is no suggestion in the least" of potential toxicity, Guess said. Weissinger told Dexide that FDA will "sit down, go over [the data] together and come up with a recommendation." She added that the agency would update the company on any internal meetings or other developments concerning chloroxylenol.

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