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FDA approves revised Micotil 300 labeling

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Elanco Animal Health worked with agency to decrease risk of accidental human injection and other potential routes of exposure.

The U.S. Food and Drug Administration (FDA) has approved revised labeling for Micotil 300 (tilmicosin injection) that addresses 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. 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. 

The FDA previously published an Animal Drug Safety Communication External Link Disclaimer 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,” FDA stated.

 

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