FDA Warns Against Use of Unapproved Aspirin in Lactating Dairy Cattle
Source: DairyNews.today
The U.S. Food and Drug Administration (FDA) has issued a warning to veterinarians and dairy farmers regarding the use of unapproved aspirin to treat pyrexia and pain in lactating dairy cattle.
This announcement comes in response to increasing concerns about the treatment of cattle infected with highly pathogenic avian influenza (HPAI), specifically type A H5N1, as some farms have been utilizing unapproved nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin.
According to a letter published by the FDA on October 11, the use of aspirin in lactating dairy cattle is illegal under the extra-label use of drugs in food-producing animals. The letter emphasizes that there are no FDA-approved aspirin products for this purpose and highlights the risks of using unapproved drugs, which include the potential for violative residues in milk and meat products.
FDA-Approved Alternatives Available
The FDA recommends the use of flunixin meglumine, the only FDA-approved drug for controlling pyrexia and inflammation in lactating dairy cattle. This drug is specifically approved for treating conditions associated with bovine respiratory disease and endotoxemia and has established milk and meat withdrawal periods, ensuring food safety.
While Vazalore, an FDA-approved human aspirin product, may be used in food-producing species under specific circumstances outlined by the Animal Medicinal Drug Use Clarification Act (AMDUCA), its limited dosages (81 mg and 325 mg) are impractical for use in dairy cattle. Consequently, some farms have turned to larger, unapproved aspirin products, which are not permissible under current FDA regulations.
Clarification on Extralabel Drug Use
AMDUCA permits extralabel use of human or animal drugs in food-producing species only when a valid veterinarian-client-patient relationship is in place, and no FDA-approved alternatives are available or effective. However, the FDA clarified that due to the availability of approved treatments like flunixin meglumine, the use of unapproved aspirin products is now considered illegal. This represents a shift in FDA policy, as aspirin was previously considered a low regulatory concern.
The FDA urges veterinarians and farmers to exercise caution and, if aspirin has already been administered, to establish extended milk and meat withdrawal periods to protect consumer safety.
Impact of H5N1 on Dairy Cattle
As of October 21, H5N1 has been confirmed in dairy cattle across 14 states, including large numbers of herds in California (131), Colorado (64), Idaho (33), Michigan (29), and Texas (26). The spread of the virus has prompted increased scrutiny on the treatment protocols used for affected cattle.
The FDA’s communication highlights the need for strict adherence to approved veterinary practices and the use of safe, effective drugs in food-producing animals. Dairy farms are encouraged to work closely with veterinarians to ensure compliance with FDA guidelines and protect the integrity of the food supply chain.
For more information and guidance, veterinarians and farmers are advised to refer to the FDA's official publications and the American Association of Bovine Practitioners (AABP).
According to a letter published by the FDA on October 11, the use of aspirin in lactating dairy cattle is illegal under the extra-label use of drugs in food-producing animals. The letter emphasizes that there are no FDA-approved aspirin products for this purpose and highlights the risks of using unapproved drugs, which include the potential for violative residues in milk and meat products.
FDA-Approved Alternatives Available
The FDA recommends the use of flunixin meglumine, the only FDA-approved drug for controlling pyrexia and inflammation in lactating dairy cattle. This drug is specifically approved for treating conditions associated with bovine respiratory disease and endotoxemia and has established milk and meat withdrawal periods, ensuring food safety.
While Vazalore, an FDA-approved human aspirin product, may be used in food-producing species under specific circumstances outlined by the Animal Medicinal Drug Use Clarification Act (AMDUCA), its limited dosages (81 mg and 325 mg) are impractical for use in dairy cattle. Consequently, some farms have turned to larger, unapproved aspirin products, which are not permissible under current FDA regulations.
Clarification on Extralabel Drug Use
AMDUCA permits extralabel use of human or animal drugs in food-producing species only when a valid veterinarian-client-patient relationship is in place, and no FDA-approved alternatives are available or effective. However, the FDA clarified that due to the availability of approved treatments like flunixin meglumine, the use of unapproved aspirin products is now considered illegal. This represents a shift in FDA policy, as aspirin was previously considered a low regulatory concern.
The FDA urges veterinarians and farmers to exercise caution and, if aspirin has already been administered, to establish extended milk and meat withdrawal periods to protect consumer safety.
Impact of H5N1 on Dairy Cattle
As of October 21, H5N1 has been confirmed in dairy cattle across 14 states, including large numbers of herds in California (131), Colorado (64), Idaho (33), Michigan (29), and Texas (26). The spread of the virus has prompted increased scrutiny on the treatment protocols used for affected cattle.
The FDA’s communication highlights the need for strict adherence to approved veterinary practices and the use of safe, effective drugs in food-producing animals. Dairy farms are encouraged to work closely with veterinarians to ensure compliance with FDA guidelines and protect the integrity of the food supply chain.
For more information and guidance, veterinarians and farmers are advised to refer to the FDA's official publications and the American Association of Bovine Practitioners (AABP).
