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The Veterinary Drugs Directorate (VDD) posts safety alerts, public health advisories, press releases and other notices as a service to health professionals, veterinarians and other interested parties. Although VDD approves therapeutic products, VDD does not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Elanco Animal Health, Division of Eli Lilly Canada Inc. Please contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on
MICOTIL®
June 16, 2004
Dear Doctor:
Health Canada and Elanco Animal Health have identified a risk of potential fatal outcomes upon accidental self-injection of Micotil®. Elanco Animal Health has been working closely with the Veterinary Drugs Directorate to ensure that the proper handling and administration of Micotil® is reinforced. Since the Micotil® approval in 1992, there have been reported cases to the Canadian Poison Control Centres of adverse human reactions to Micotil. The route of exposure in the majority of cases is by accidental puncture / scratch / injection, with oral ingestion, face/eyes and dermal exposure occurring infrequently. Micotil® is a macrolide veterinary antibiotic with cardiotoxic side-effects. It causes negative inotropy and in cases of accidental human exposure, requires constant cardiovascular system monitoring. Accidental needle puncture of less than 1 mL usually results in nothing more than edema and/or pain at the site of injection, however, higher doses can result in fatalities. In Canada, none of these reports have been of a serious nature, however, in the US, accidental injection of a full dose for cattle has been associated with fatalities. As these reactions are serious, the product monograph has been changed to reflect this new safety information.
HUMAN WARNING: Not for human use. Human injection has been associated with fatalities. Do not use in automatically powered syringes. Exercise caution to avoid accidental self-injection. In case of human injection, consult a physician immediately and apply ice to injection site. For emergency medical information call 1-416-813-5900.
NOTE TO THE PHYSICIAN: The cardiovascular system is the target of toxicity and should be monitored closely. This antibiotic persists in tissues for several days. Apply ice to injection site and provide supportive treatment. Epinephrine potentiated lethality of Micotil in pigs. Dobutamine partially offset the negative inotropic effects induced by Micotil in dogs. 
-adrenergic antagonists, such as propranolol, exacerbated the negative inotropy of Micotil-induced tachycardia in dogs.
As a veterinarian, you play a key role in protecting clients from accidental exposure or self-injection. We encourage you to continue to diligently train your clinic staff regarding safe handling procedures and take steps to ensure they are providing appropriate information to clients when dispensing Micotil®. This notice serves to remind the veterinary community of caution when handling any veterinary drug as well as to inform you of the changes to the monograph. Below is a reminder of proper handling of Micotil®.
Proper Injectable Handling Procedures
- Store Micotil® in a safe location
- Read, understand and follow all label use directions
- For subcutaneous use in cattle
- Use a 1/2 " to 5/8" 18- to 16-gauge needle
- Keep a protective cover on needles until ready to use
- Never carry loaded syringe in pocket or clothing
- Wash hands thoroughly with soap and water after handling
Proper Injectable Administration Procedures
- Properly restrain animals prior to administering Micotil®
- With a single hand on the syringe, insert the needle subcutaneously, at a top-down angle, while avoiding penetration of underlying muscle
- Administer a single subcutaneous dose of 1.5 mL of Micotil® per 100 lbs of body weight
- Ensure proper disposal of sharp needles and syringes
Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with drug treatments. The identification, characterization, and management of marketed health product-related adverse events are dependent on the active participation of veterinarians in adverse drug reaction reporting programmes. Any occurrences of human exposures or other serious and/or unexpected adverse events in animals receiving Micotil® should be reported to Elanco Animal Health using the following contact information:
Elanco Animal Health
Division of Eli Lilly Canada Inc.
Research Park Centre
150 Research Park Lane, Suite 120
Guelph, ON N1G 4T2
Tel: 1-800-265-5475 or Fax: (519) 821-7831
Sincerely yours,
Paul Dick, B.Sc., D.V.M., M.Sc.
Manager, Research and Development and Technical Service
Any suspected human or animal adverse incident can also be reported to:
Pharmacovigilance Unit
Veterinary Drugs Directorate
HEALTH CANADA
Address Locator: 3000A
Ground Floor, Suite 14, Holland Cross Complex
11 Holland Avenue
Ottawa, ON K1A 0K9
Tel: 1-877-VET-REAC (1-877-838-7322) or Fax: (613) 946-1125
The ADR Reporting Form can be found on the Veterinary Drugs Directorate Web site or in The Canadian Compendium of Veterinary Products.
