FDA Animal Drug Safety Communication: Micotil 300 Labeling Change

FDA Animal Drug Safety Communication: Micotil 300 Labeling Change

The information below has been supplied by dairy marketers and other industry organizations. It has not been edited, verified or endorsed by Hoard’s Dairyman.

The U.S. Food and Drug Administration has approved revised labeling for Micotil 300 (tilmicosin injection), an injectable drug for use in certain cattle and sheep. These changes address risks to people handling or administering the drug. Human injection with Micotil 300 can lead to severe cardiac effects and death.

Elanco Animal Health, the sponsor of Micotil 300, worked with the FDA to decrease the risk of accidental human injection and other potential routes of exposure (such as through the mouth, on the skin or in the eye). The drug is now packaged inside a tamper-proof shroud and access to the product requires a quick-connect device, which is provided with a tube-fed safety syringe by Elanco or its distributors. Safe use and handling instructions are attached to the shroud so that the user can review them each time they handle the product. The labeling also includes updated warning language about user and animal safety. Information on the labeling updates with diagrams of the shroud is on the FDA website.

The FDA previously published an Animal Drug Safety Communication to alert cattle and sheep owners, farmworkers, veterinarians, physicians, emergency medical technicians, and other health care providers about the potential hazards to people accidentally exposed to Micotil 300.

People exposed to Micotil 300, whether through accidental injection or through the mouth, skin, or eye, should immediately seek medical care. There is no antidote for Micotil 300. This drug has been shown to have toxic effects on the human heart. In some cases of exposure, people required hospitalization and prolonged medical care; some people have died despite receiving medical care. Injections in people of less than 0.5 ml (1/10 teaspoon) have been associated with pain and bleeding at the injection site, while larger volumes have been associated with nausea, dizziness, rapid heart rate, and death.

It is crucial that every person who handles Micotil 300 be appropriately trained to use the drug safely, in a controlled setting where cattle are appropriately restrained. Uncontrolled livestock environments can be unpredictable and potentially hazardous, which increases the risk for handlers to be accidentally exposed to Micotil 300. In cases where a person has been accidentally exposed to Micotil 300 and needs medical care, first responders and medical personnel may find it helpful to consult the Rocky Mountain Poison and Drug Center (RMPDC) at 1-800-722-0987.

The FDA encourages you to report any adverse events in people or animals associated with the use of Micotil 300. Human adverse experiences should be reported to Elanco Animal Health at 1-800-428-4441. For information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at How to Report Animal Drug and Device Side Effects and Product Problems.

FDA Animal Drug Safety Communication: Micotil 300 Labeling Change

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