Baytril^® Use in Swine

July 16, 2008 — 

The U.S. Food and Drug Administration (FDA) recently approved the use of Baytril^® in swine. This drug however finds itself in a somewhat unique position in that while there are approved uses for the product in swine, the fluoroquinolones as a class are banned by the FDA for extra-label use. This is an important distinction to keep in mind when prescribing Baytril^® to your swine clients.

What this means is that the only legal use of Baytril^® in food-producing animals by veterinarians and producers is in the manner stated on the product label. In other words, the product may only be used at a single-injection dosage of 7.5mg/kg of body weight administered by subcutaneous injection behind the ear for the treatment and control of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. Animals intended for human consumption must not be slaughtered within 5 days following injection.

There is no legal option to prescribe or use Baytril^® in any extra-label manner. This means that the veterinarian cannot prescribe this drug to be administered by any route other than a single subcutaneous injection behind the ear, or at any dosage other than 7.5mg/kg, or to treat or control any condition other than respiratory diseases associated with the bacteria listed above. Likewise, producers may not deviate from the labeled usage either.

It should also be noted that the FDA is proposing to add cephalosporins to the prohibited list of drugs as well. Thus, unless FDA reverses its decision, effective October 1, it will no longer be legal to prescribe cephalosporins in an extra-label manner either. This means that drugs including Naxcel^®, Excede^® and Excenel^® will only be available for use in food-producing animals as specifically labeled.

The list of other drugs banned from extra-label use can be found online at http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ActsRulesRegulations/ucm085377.htm.

Remember that the veterinarian is legally responsible for the proper use of products prescribed for use in food-producing animals.