Also on Monday, the American Association for Bovine Practitioners (AABP) published a podcast, which further explained this change in regulatory priorities.
Since at least the 1960s numerous brands of aspirin containing oral products have been marketed for cattle in the U.S. including bolus, powder and liquid formulations. None of these products however have completed the rigorous FDA animal drug approval process. Until CVM’s letter dated October 11th, aspirin was a member of a very short list of unapproved animal drugs, including lidocaine, epinephrine and intravenous calcium solutions, for which FDA used “regulatory discretion” allowing continued marketing because they were of “low regulatory concern”.
Increasing use of aspirin in cattle during the current HPAI outbreak, the availability of other anti-inflammatory drugs labeled for cattle and media inquiries about the potential impacts to food safety prompted the FDA to determine that aspirin in dairy cattle was no longer of low regulatory concern and publish the letter.
As an alternative to aspirin there are a number of anti-inflammatory products that have FDA label approvals for some diseases in lactating dairy cows, although importantly not HPAI. These includes at least six intravenous flunixin-containing products, all having the same 36-hour milk and 4-day slaughter withdrawal periods. There is also a single pour-on flunixin product with 48-hour milk withdrawal and 8-day slaughter withdrawal periods when used according to the label. Importantly the withdrawal times for this pouron product are only valid for a single treatment. Extra-label usage for this product, which include using additional treatments, would require the prescribing veterinarian to provide the appropriate indications for extra-label usage and the appropriate extended withdrawal times.
It is essential that hospital pen employees using flunixin products be properly trained in administration. Injection of flunixin outside the vein can result in damaged jugular veins and extended withdrawal times. IM or SQ injections can result in large, painful injection sites with tissue damage and extended meat and milk withdrawal times. Finally, veterinary literature and product labels generally caution against the use of flunixin in dehydrated animals to avoid GI and kidney damage. Your veterinarian might direct that cows be completely rehydrated before flunixin administration.
As with all prescription medications, producers considering flunixin use in cows should consult with their herd veterinarian. This is particularly true for flunixin products which are not labeled for use in cows infected with HPAI.
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