FDA Says New Antimicrobial Report Will Help Evaluate Resistance Trends

New antimicrobial report will help evaluate resistance trends, according to FDA.

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The U.S. Food and Drug Administration’s Center for Veterinary Medicine today published its first report summarizing sales and distribution data of antimicrobial drugs approved for food-producing animals.

The report, to be published annually, provides concrete data important for supporting efforts to track antimicrobial use trends and how such trends relate to antimicrobial resistance, according to the FDA.

“Because more use of antimicrobials is, in general, associated with greater levels of resistance, these data will supplement the FDA’s ongoing activities in antimicrobial resistance prevention,” the FDA reported. “It also reinforces a recent agency draft guidance on the judicious use of certain antimicrobials in food-producing animals.”

This first report covers 2009 figures.

In the domestic category, nine antimicrobial classes with corresponding annual totals (kilogram of active ingredient) are listed: aminoglycosides at 339,678 kg; cephalosporins at 41,328 kg; ionophores at about 3.7 million kg; lincosamides at 115,837 kg; macrolides at 861,985 kg; penicillins at 610,514 kg; sulfas at 517,873 kg; and tetracyclines at about 4.6 million kg.

The ninth antimicrobial class, dubbed “not independently reported” (NIR), included antimicrobial classes for which there were less than three distinct sponsors actively marketing products domestically. NIR had an annual total of about 2.2 million kg.

In the export category, tetracyclines came in at an annual total of 515,819 kg. The second antimicrobial class, dubbed “not independently reported export” had an annual total of about 1.1 million kg.

The annual totals reflect all approved uses of all dosage forms, including injectable, oral and medicated feed.

The FDA noted that its scientists are reviewing the sales and distribution data and their relationship to known resistance patterns.

“However, meaningful trend analyses may not be possible until several years of comparable sales and distribution data are reported,” the agency said.


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