FDA issues alert on Micotil user safety

Elanco, which distributes the product, is currently working in consultation with FDA to further address this issue.

The U.S. Food & Drug Administration issued an alert Sept. 11 to cattle and sheep owners, farmworkers, veterinarians, physicians, emergency medical technicians and other health care providers about the potential hazards to people exposed to the animal drug Micotil 300 (tilmicosin).

Micotil 300 is a prescription injectable antibiotic used to treat respiratory disease in cattle and sheep.

Elanco Animal Health, a subsidiary of Eli Lilly & Co., distributes Micotil 300 and has made efforts to warn and educate people about the human health risks associated with this product and to provide training to users and veterinarians on safe handling and use of Micotil 300. Elanco is currently working in consultation with FDA to further address this issue.

According to FDA, since its approval in 1992, there have been more than 2,200 adverse event reports involving people exposed to Micotil 300. These include multiple reports of injury, including death, in people following injection of Micotil 300. Other routes of exposure, including by mouth or skin, have also led to injury, FDA said. Most of the reported human exposures were accidental and many cases required medical attention. While the circumstances remain unclear in some cases, there have been 25 reports involving human death. Although a majority of these deaths were due to intentional self administration of the drug, some deaths were reported following accidental injection.

People exposed to Micotil 300 should immediately seek medical care, FDA warned. 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.

FDA emphasized that it is crucial that every person who handles Micotil 300 has been appropriately trained to use the drug safely and understands the risks to people handling this drug. The prescribing information for Micotil 300 includes important information for users in a section called SAFE HANDLING PRACTICES WHEN USING MICOTIL® 300 TILMICOSIN INJECTION.

FDA encourages any adverse events in people associated with the use of Micotil 300 to be reported. Human adverse experiences should be reported to Rocky Mountain Poison & Drug Center (RMPDC) at (800) 722-0987 or Elanco Animal Health at (800) 428-4441. For information about adverse drug experience reporting for animal drugs, contact FDA at (888) FDA-VETS or online at www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm.

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