Antimicrobial Consumer Product Resistance Concerns Voiced By AMA

The use of consumer products containing antimicrobial agents could be creating a favorable environment for organisms resistant to antibiotics, according to a report approved by the American Medical Association at its annual meeting in Chicago June 11-15.

"The possibility that the selection of organisms resistant to antimicrobials such as triclosan and chlorhexidine... may predispose these organisms to resistance against therapeutic antibiotics is troubling," the report says.

Moreover, "considering the available data and the critical nature of the antibiotic resistance problem, it may be prudent to avoid the use of antimicrobial agents in consumer products," the AMA report continues.

The report was drafted in response to a resolution passed at AMA's 1999 annual meeting. The resolution called on AMA to investigate the effectiveness and long-term implications of consumer products containing antimicrobial agents and make recommendations concerning consumer education and government regulation of such products (¹ (Also see "AMA Discourages Physician Sale Of "Health-Related Products"" - Pink Sheet, 5 Jul, 1999.)).

AMA's Council on Scientific Affairs searched MEDLINE, Lexis/Nexis and the Internet for articles written between 1966 and 1999. Ingredients considered included triclocarban, triclosan, cetylpyridium chloride and chlorhexidine. Products that contain triclosan include Stridex (Blistex) and Oxy (SmithKline Beecham) facial cleansers, as well as Softsoap (Colgate-Palmolive), Dial (Dial) and Safeguard (Procter & Gamble) hand washes.

Based on its search, the council reported that little evidence supports the efficacy of antimicrobial products in a consumer setting. CSA cites a position statement prepared by the Association for Professionals in Infection Control stating "'no scientific data support the use of antimicrobial agents in household products as a means to prevent infection.'"

Regarding bacterial resistance, AMA admits there are little data showing consumer products have contributed to this trend, and, "ultimately, health care practitioners must control antibiotic resistance through judicious use of these important drugs." However, since scientific studies have not supported the use of antimicrobials in consumer products, CSA states "it may be prudent to avoid" their use.

Following public comment on the report, a new resolution was passed containing three statements, the first of which calls on AMA to encourage FDA to "expedite [its] regulation of the use in consumer products of antimicrobials for which acquired resistance has been demonstrated."

The other two call on AMA to "monitor the progress of the current FDA evaluation of the safety and effectiveness of antimicrobials for consumer use in [OTC] hand and body washes," and to "encourage continued research on the use of common antimicrobials as ingredients in consumer products and its impact on the major public health problem of antimicrobial resistance."

FDA is currently evaluating testing methodologies for antimicrobial products; the agency met with the Cosmetic, Toiletry & Fragrance Association and Soap & Detergent Association Nov. 3 to discuss the topic (² (Also see "Topical Antimicrobial Test Standards Created By Third Party Possible - FDA" - Pink Sheet, 8 Nov, 1999.)).

Following the resolution's passage, FDA released a statement noting it is evaluating the safety and effectiveness of topical antimicrobials for consumer use, and is "considering the issue of resistance...and the impact on the public health." FDA is working on a feedback letter to address issues discussed at the Nov. 3 meeting.

CTFA and SDA called the AMA report and resolution "a mistake," saying its recommendations are based on "untested scientific theory."

"In speculating on the role of personal care products in causing antibiotic resistance, the [AMA] is diverting attention away from the proven causes of antibacterial resistance," the trade groups state. The "over-prescription" of antibiotics is the "key reason for the emergence of antibiotic resistance," they maintain.

Noting CTFA and SDA's objections, AMA said its report does not state "the use of antimicrobials in consumer products is a significant reason for antibiotic resistance," but that such use "may be a potential source of antibiotic resistant organisms."

Sens. Bill Frist, MD, (R-Tenn.) and Edward Kennedy (D-Mass.) introduced a bill (S 2731) June 14 that would establish an "Antimicrobial Task Force" responsible for studying contributing factors to antimicrobial resistance, monitoring resistance and developing control strategies of resistant pathogens. The "Public Health Threats and Emergencies Act" was referred to the Senate Health & Education Committee.