Label revised for drug used to treat respiratory disease in cattle and sheep

Officials from the FDA have approved revised labeling of tilmicosin injection (Micotil 300; Elanco Animal Health) for certain cattle and sheep.¹ The drug is indicated to treat bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni; and ovine respiratory disease associated with Mannheimia haemolytica.²

The change of labeling is to help protect those who administer this drug. An accidental human injection of tilmicosin can lead to severe cardiac effects, with some cases resulting in hospitalization, prolonged medical care, and even death, according to the FDA.¹

Elanco Animal Health worked with the FDA to help decrease the number of accidental human injections and other potential ways of exposure including through the mouth, on the skin, or in the eye. The product's new packaging has the drug in a tamper-proof shroud and requires a quick-connect device with a tube-fed safety syringe provided by Elanco and its distributors.¹ The new labeling will also include safe use and handling instructions located on the shroud, and an updated warning language about animal and user safety.

Anyone who handles tilmicosin injection must be trained appropriately to use it safely in a controlled setting with cattle correctly restrained. In 2017, the FDA published an Animal Drug Safety Communication to alert veterinarians, farm workers, physicians, emergency medical technicians, cattle and sheep owners, and other health care providers about the hazards of accidental exposure to tilmicosin.³

Humans exposed to tilmicosin should seek medical care immediately. Those who have been accidentally injected with less than 0.5 ml (1/10 teaspoon) are at risk of pain and bleeding at the injection site with larger volumes associated with dizziness, nausea, rapid heart rate, and death.¹

References

1. FDA Animal Drug Safety Communication: Micotil 300 Labeling Change. News release. FDA. December 13, 2022. Accessed December 13, 2022. https://www.fda.gov/animal-veterinary/cvm-updates/fda-animal-drug-safety-communication-micotil-300-labeling-change
2. Animal drug safety-related labeling changes. News release. FDA. December 13, 2022. Accessed December 13, 2022. https://www.fda.gov/animal-veterinary/drug-labels/animal-drug-safety-related-labeling-changes#micotil
3. FDA Animal Drug Safety Communication: Micotil 300 User Safety Alert. News release. FDA. September 11, 2017. Accessed December 13, 2022. https://wayback.archive-it.org/7993/20190424114815/https:/www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm575194.htm