FDA


The FDA’s Center for Veterinary Medicine has posted updated Cumulative Adverse Drug Experiences (ADE) Summaries Reports, containing data from 1987 through 11 April 2007.

More information about the ADE reports can be found here and here (the latter page describes limitations in the ADE reports). An FAQ on the ADE reports is here. The form for submitting an ADE is here.

Reports are arranged by active ingredient (generic drug names are used), species, and route of administration. Some drugs have hundreds or thousands of reports; others have only a handful. Each report includes a list of reported reactions. Unfortunately, reaction types don’t seem to be fully standardized, so one can find the same type of reaction listed several different ways. For example, the report on carprofen administered orally to cats lists eight reports of “K HI, BLD” and one report of “K HI, BLOOD.” Similarly, what is the difference between “HYPOTHERMIA” and “HYPOTHERMIA, BODY,” both of which are reported six times. Some of the reported reactions are puzzling: one cryptic reaction reported for carprofen is “BLD.”

Still, the ADE reports are a wonderful resource for veterinarians who might be wondering if the odd reaction they’re seeing to a drug has been reported by anyone else.

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A woman in Chicago has filed suit against Menu Foods, the AP reports. According to the report the woman “took the 9-year-old cat to its first-ever veterinarian visit the day of the recall” (emphasis added).

A story in the Pittsburgh Post-Gazette reports on a telephone news conference FDA officials held yesterday with reporters. The conference clarified a few matters:

  • Fourteen confirmed deaths (one dog, thirteen cats) led to the recall, including nine from Menu “tasting trials.” The dog and four cats were companion animals (i.e., pets).
  • “The test animals that died were involved in quarterly taste tests routinely done by Menu. The animals were not intentionally given tainted food, as earlier FDA reports had indicated.”
  • The FDA believes the tainted food came only from Menu’s Kansas plant. (Menu also has a plant in New Jersey.)

Also, while Menu still believes wheat gluten is the problem ingredient, “officials are looking at other products and ingredients, including substances that are known to be toxic to the kidneys of dogs and cats.” Catmanager wonders what the writer means by “other products.”

New Jersey’s Star-Ledger runs a story on Menu’s (mis)handling of the PR aspect of the recall and quotes several communications experts who say Menu blew it. “‘You’ve got 60 to 120 minutes,’ . . . because bloggers and Internet chat rooms will start buzzing about the problem.” (Seems about right. I mentioned the story in my Friday news roundup about two hours after if broke and about forty minutes after I found it on the Veterinary Technician’s Journal blog.)

In an unrelated event, a class-action lawsuit was filed in Canada against Royal Canin over pet deaths alleged to have been caused by last year’s vitamin D–related food recall. Reports of the suit all note that it is unrelated to the Menu Foods recall.

The first hour of today’s Diane Rehm Show featured a discussion of the U.S. Food and Drug Administration with Dr. Janet Woodcock, deputy commissioner and chief medical officer of the FDA; David Kessler, former FDA commissioner; and Gardiner Harris, a reporter with the New York Times. Audio of the segment, which included discussion of antibiotic use in food animals and the recent news stories about the agency’s decision to fast-track cefquinome, can be found here (mp3), here (RealAudio), or here (Windows Media).