Information on Fluoroquinolone

Antimicrobial resistance is a growing public health concern. To help maintain the efficacy of antimicrobial drugs for the treatment of important human diseases, regulators have restricted the use of newer classes of antimicrobials drugs such as the fluoroquinolones (e.g. enrofloxacin, danofloxacin and sarafloxacin). Although fluoroquinolone products have been approved for the treatment of specific conditions in certain food-producing animal species, the FDA has set conditions for their use.

These conditions are that:

1. fluoroquinolones be sold by veterinary prescription only,
2. fluoroquinolones are approved for therapeutic uses only (no sub-therapeutic or growth promotion uses),
3. no extralabel use of these products is allowed, and
4. the FDA-CVM institute a monitoring system to detect emerging antimicrobial resistance and mitigate it in a timely fashion.

In October 2000, the FDA-CVM announced a proposal to withdraw the approval for the use of fluoroquinolone in poultry. This proposal was based on evidence gathered by the CVM that the use of fluoroquinolone in poultry caused the development of resistance to fluoroquinolone in Campylobacter in poultry and that this was a significant cause of resistant Campylobacter infections in humans. Following an examination of the evidence by US courts, the FDA-CVM announced that, effective September 12, 2005, fluoroquinolone products approved for poultry are to be withdrawn from the market and may no longer be sold, distributed or administered to chickens or turkeys.

This decision does not affect other approved uses of fluoroquinolones (i.e., enrofloxacin and danofloxacin approved for beef cattle, not including dairy).

The following links provide more information on this subject:

• Prohibited drugs digest
• FARAD newsletter
• FDA announcement
• Full documentation