Northern Ag Network
Northern Ag Network
Northern Broadcasting System    Northern News Network    Northern Sports Network
Search This Site...
Search This Site...
FDA Animal Drug Safety Communication: Micotil 300 User Safety Alert

FDA Animal Drug Safety Communication: Micotil 300 User Safety Alert

9/12/2017 2:23:00 PM/Categories: Popular Posts, General News, Livestock, National News

September 11, 2017

The U.S. Food and Drug Administration is alerting 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.

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. 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 the 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. 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.

Elanco Animal Health, a subsidiary of Eli Lilly and Company, 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 the FDA to further address this issue.

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. Livestock environments can be unpredictable and potentially hazardous. This can increase the risk of accidental exposure to Micotil 300. 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 you to report any adverse events in people associated with the use of Micotil 300. Human adverse experiences should be reported to Rocky Mountain Poison and Drug Center (RMPDC) at 1-800-722-0987 or 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 https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm.

The labeling for Micotil 300 (NADA 140-929) contains the following boxed warnings presented in English and Spanish:

Human Warnings: Not for human use. Injection of this drug in humans has been associated with fatalities. Keep out of reach of children. Do not use in automatically powered syringes. Exercise extreme caution to avoid accidental self-injection. In case of human injection, consult a physician immediately and apply ice or cold pack to injection site while avoiding direct contact with the skin. Emergency medical telephone numbers are 1-800-722-0987 or 1-800-428-4441. Avoid contact with eyes.


Note To The Physician: The cardiovascular system is the target of toxicity and should be monitored closely. Cardiovascular toxicity may be due to calcium channel blockade. In dogs, administration of intravenous calcium offset Micotil-induced tachycardia and negative inotropy (decreased contractility). Dobutamine partially offset the negative inotropic effects induced by Micotil in dogs. β-adrenergic antagonists, such as propranolol, exacerbated the negative inotropy of Micotil in dogs. Epinephrine potentiated lethality of Micotil in pigs. This antibiotic persists in tissues for several days.

Contact FDA

240-402-7002
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7519 Standish Place, HFV-1

Rockville, MD 20855
Print
Tags:

Leave a comment

Name:
Email:
Comment:
Add comment

Name:
Email:
Subject:
Message:
x

Recent Ag News

SD Stockgrowers Launch Search for Executive Director

6/19/2018 6:07:00 AM
The South Dakota Stockgrowers Association has launched the search for a new Executive Director. The Board of Directors is inviting applications from interested candidates to be submitted immediately. >> Read More
Article rating: No rating

DNA Results in For Mysterious Canine Shot Near Denton

6/18/2018 10:53:00 AM

The canine creature shot in Montana a month ago that captured the curiosity of the nation is actually a gray wolf.


>> Read More
Article rating: No rating

Federal Judge Rules Against California’s Attorney General in Prop 65 Case

6/16/2018 5:00:00 AM
In another win for U.S. agriculture and the national agriculture coalition fighting California’s false and misleading Prop 65 labeling requirement for glyphosate, U.S. District Court Judge William Shubb, for the Eastern District of California, upheld the preliminary injunction prohibiting California from enforcing the requirement until a final ruling on the matter is issued by the court.  >> Read More
Article rating: No rating

Montana Stockgrowers Midyear Heads to Dillon

6/15/2018 8:01:00 AM

Ranchers from across Montana have gathered in Dillon for the Montana Stockgrowers Association's  Midyear Meeting.
Lane Nordlund reports from the event along with its highlights. 

>> Read More
Article rating: No rating

Low-Interest Loans Available for Montana Producers Impacted by Winter Weather

6/15/2018 6:00:00 AM
Agricultural producers in Montana who lost property in recent natural disasters are eligible for physical loss loans from the U.S. Department of Agriculture (USDA). >> Read More
Article rating: No rating
RSS

Find Articles by Date

«June 2018»
MonTueWedThuFriSatSun
2823
910
17
2021222324
2526272829301
2345678