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FDA Staff Gets Support for New Antiseptic Standards, but...

Larry Hand

September 04, 2014

A US Food and Drug Administration (FDA) advisory committee strongly supported FDA staff members' proposed new
minimum safety data standards for antiseptics used by healthcare providers but stopped short of going along with
recategorizing 3 highly common topical antiseptics.
Such an action would remove alcohol (ethanol), isopropyl alcohol, and iodine from the category of generally recognized
as safe (GRAS; category 1) and put them in category 3 (insufficient data to classify).
Committee members, however, questioned why such a move is necessary, considering that the antiseptic ingredients
have been used for decades and the FDA staff did not present evidence that chronic, repetitive use by healthcare
providers was unsafe.
Such a reclassifying could be interpreted as a warning and leave the public at greater risk for potential infection by
reducing handwashing compliance at healthcare centers, committee members said.
No such warnings are necessary, "until we know what they are and how they're going to be communicated," said
committee chair Ruth M. Parker, MD, professor of medicine at Emory University Medical School in Atlanta, Georgia.
Meeting September 3, the FDA's Nonprescription Drugs Advisory Committee voted unanimously (12 to 0) to
recommend that the staff members go ahead and propose new safety standards for 11 common over-the-counter
healthcare antiseptic ingredients.
Five ingredients alcohol, isopropyl alcohol, povidone-iodine, iodine tincture, and iodine aqueous solution are
classified as GRAS. (The committee generalized iodine for 3 of the 5 ingredients to arrive at the 3 common antiseptics
mentioned earlier.)
Six ingredients benzalkonium chloride, benzethonium chloride, chloroxylenol, hexylresorcinol, triclocarban, and
triclosan are category 3.
The substances are regulated according to the FDA's monograph process rather than under the agency's drug approval
process. Under that process, over-the-counter drug products are subject to a "rule book," overseen by FDA staff and
approved by the FDA commissioner, and are not subject to review and approval by the FDA overall.
Active Ingredients Only
In addition, regulation covers only how active ingredients are used and not subsequent marketed formulations. Active
ingredients, once included in a monograph, can be combined with other ingredients to make a product.
At the committee meeting, FDA staff members said that since the products were initially classified as safe, new data
have emerged, as well as more sophisticated scientific methods to test products. The 5 GRAS products mentioned
earlier were included in a 1994 monograph. New proposed safety data standards, they said, are warranted even for
commonly used products.
"Because these products are so ubiquitous, we tend to take them for granted," Theresa Michele, MD, director of the
FDA's Division of Nonprescription Clinical Evaluation, told panel members. In addition, she said, the benefit/risk profile
is different for these products because the benefit is provided to a different person (a patient) than the person taking the
risk (a healthcare provider).
Staff members were asking committee members for advice only on safety, not efficacy, which proved to be another
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issue later in the day.

Staff members provided the panel with some of the data that have developed in more recent years, including:
indications that exposure to topical antiseptic ingredients may be greater than "previously thought";
studies showing blood alcohol levels after use of alcohol-based hand rubs or surgical hand rubs;
studies showing that triclosan gets absorbed through the skin and has been found in human breast milk and
urine;
information suggesting that some healthcare antiseptics may have hormonal effects; and
new information pointing to possible concerns regarding how widespread use of these antiseptics may affect
development of antimicrobial resistance mechanisms in common with antibiotics.
Staffers emphasized, however, that many other healthcare antiseptic ingredients have not been studied at all in a safety
context and that large data gaps exist. In addition, most studies have only looked at short time frames, not long-term
use as it applies to healthcare workers.
The staff proposed 4 broad categories of studies as "the minimum data FDA believes necessary to establish the safety
of long-term, daily, repeated exposure to healthcare antiseptic active ingredients." The categories are human safety
studies, nonclinical animal studies including toxicokinetics, studies to characterize hormonal effects, and studies to
assess any effect on antimicrobial resistance.
Going Too Far?
Industry representatives voiced strong concerns at the meeting about the proposed new standards.
"Category 1 products could be called into question with no evidence to suggest a real risk," said Paul C. DeLeo, PhD,
associate vice president of the American Cleaning Institute, Washington, DC. "Alcohol-based hand rubs have been
used safely for decades on a global basis."
He said that healthcare antiseptics have a long history of safe use with no evidence of adverse effects, and that "a
robust body of research supports their use."
Dr. DeLeo added that the FDA staff document presented to panel members "falls well short of the totality" of available
evidence.
In addition to reducing the rate of hospital-acquired infections and mortality from those infections, hand rubs improve
healthcare efficiency by saving nurses' time spent cleaning their hands, said William R. Jarvis, MD, a consultant in
infection control. He cited a study that found that in a typical nurse's 8-hour day, soap and water handwashing could
take up 56 minutes compared with 18 minutes of cleaning with hand rubs.
Industry representatives emphasized that patient safety could be highly jeopardized, particularly if any healthcare
antiseptic products ended up being taken off the market.
FDA officials countered about the marketing, saying that the intent was to leave all products on the market as future
testing took place. "We're not trying to take ingredients off the market," Dr. Michele said. "We're trying to set standards
on what data are needed."
End of the Day

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Although the panel members voted unanimously to recommend the new standards, they backed off quickly about the
reclassifying of category 1 antiseptics, saying generally that enough information is available on those products to keep
them classified as GRAS.
Panel member David J. Margolis, MD, PhD, professor of dermatology and epidemiology at the University of
Pennsylvania Perelman School of Medicine, Philadelphia, said he "didn't hear any data today that there's a real safety
issue.... It doesn't make sense to move them out of that category."
Dr. Parker, the committee chair, said she had difficulty only considering the safety aspect of the antiseptics and not
considering safety and efficacy together. "I can't just care about the [safety], I care about the [efficacy] also. At the end
of the day, the last thing I want to see is unintended consequences."
The committee members have disclosed no relevant financial relationships.
Medscape Medical News 2014 WebMD, LLC
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Cite this article: FDA Staff Gets Support for New Antiseptic Standards, but.... Medscape. Sep 04, 2014.

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