The U.S. Food and Drug Administration understands that veterinarians and dairy farmers may be treating lactating dairy cattle for pyrexia and pain with aspirin and wants to clarify that there are no FDA-approved aspirin products for use in cattle. The extralabel use of unapproved drugs in food-producing species is prohibited.
There are FDA-approved products for controlling pyrexia and pain in lactating dairy cattle that are safe, effective, and have established milk and meat withdrawal periods. All FDA-approved animal products are required to carry one of the following statements on the label:
“Approved by FDA under NADA # XXX-XXX” (for brand name animal drugs), or
“Approved by FDA under ANADA # XXX-XXX” (for generic animal drugs).
Under the Animal Medicinal Drug Use Clarification Act (also known as AMDUCA), veterinarians may use an FDA-approved human or animal drug in food-producing species under specific conditions. There is one FDA-approved human aspirin product (Vazalore) that is currently marketed. Although other human aspirin products are marketed under an over-the-counter monograph, that monograph is not an approval and, therefore, these products cannot be used in an extralabel manner. Given the impracticality of dosing cattle with a sufficient amount of the approved human product, the FDA understands that veterinarians and dairy farmers may instead be using unapproved aspirin products that are not legally marketed. The extralabel use of unapproved drug products in food-producing species is prohibited.
Veterinarians and dairy farmers should stop use of unapproved aspirin in lactating dairy cattle and use FDA-approved products to control pyrexia and pain. In the event that animals have already been treated with aspirin, veterinarians should use their scientific expertise and available resources to set protective and extended milk and meat withdrawal periods for treated animals.
(Source: FDA CVM 11 October 2024)
Additional Information from AABP
AABP Announcement
AABP has been made aware that aspirin is being used on some dairy farms that have cattle affected with the HPAI H5N1 disease outbreak. Veterinarians can prescribe drugs for extra label uses so long as they are in compliance with the Animal Medicinal Drug User Clarification Act of 1994 (AMDUCA). Some of the components of this federal legislation allowing extra label drug use include the establishment of a valid VCPR, assigning an appropriate withdrawal time, not causing violative residues, and using approved human or animal drugs. A veterinarian should not prescribe extra label drug use if there is an approved drug that is labeled for the indication unless that labeled therapy is ineffective as determined by the veterinarian.
AABP leadership has met with FDA Center for Veterinary Medicine for clarification on the extra-label use of aspirin. FDA has informed us that they have had media inquiries about aspirin use in dairy cattle. Aspirin is not an approved drug and has not gone through the drug approval process. FDA has informed AABP that using aspirin in dairy cattle for treatment of HPAI is illegal.
Previously FDA has stated that aspirin use was of low regulatory concern, however due to its increased use, questions from the public about its use, and the availability of labeled products for treatment of pyrexia (flunixin), they have shifted this stance to state such use is no longer of low regulatory concern.
AABP recommends that veterinarians review treatment protocols with clients and inform dairy producers that use of aspirin is illegal per the FDA. Treatment protocols should always come from the prescribing veterinarian of record for all diseases where farm staff have been appropriately trained to treat the most common conditions identified on the operation.
Have you Heard Podcast
What do You Need to Know about Extra Label Drug Use and Using Aspirin in Cattle?
AABP Executive Director Dr. Fred Gingrich is joined by the Dr. Alison Vander Plaats, chair of the AABP Committee on Pharmaceutical and Biologic Issues (CPBI). This podcast was created to update cattle veterinarians and farmers about extra label drug use (ELDU) and FDA’s stance on the use of aspirin in cattle. With the current HPAI H5N1 outbreak in dairy cattle, it is critical that veterinarians understand how to develop treatment protocols that are in compliance with current regulatory positions.
Veterinarians should make sure they full understand the federal Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) which outlines to criteria that must be met to incorporate ELDU in their drug treatment protocols. Vander Plaats explains that veterinarians must first utilize labeled drugs that are approved for a specific indication in that class of animals and also understand that AMDUCA allows for the ELDU of approved animal or human drugs. Aspirin is not an approved drug and does not have a New Animal Drug Approval (NADA) number, therefore it has always been illegal to use. FDA has previously stated that aspirin was of low regulatory concern, however that is no longer the position of the agency. Other unapproved drugs utilized in bovine practice, such as lidocaine, calcium solutions, and epinephrine, are not of regulatory concern due to their critical need and no alternatives that are approved. Such is not the case with aspirin and therefore veterinarians should not use aspirin in treatment protocols.
AASV Resources for Swine Veterinarians
The AASV is working to better understand this issue. Watch the e-letter and the AASV website for more information.
Only FDA-approved animal and human drugs may be used in an extralabel manner. The extralabel use of unapproved drugs in food-producing species is prohibited.
AASV Resources: Extra-label Drug Use (AMDUCA)
FDA AMDUCA website — Resource information from the FDA regarding AMDUCA.
AMDUCA and Extra-label Drug Use in Swine — A brochure providing an algorithm for the use of drugs in an extra-label manner and describing additional restrictions for the extra-label use of cephalosporins and fluoroquinolones.
AVMA: Extralabel Drug Use (ELDU) Algorithm — An online algorithm.
AMDUCA Revisited — JSHAP article describing AMDUCA in swine medicine.