Micotil (tilmicosin) - Adverse Drug Reactions - Veterinary Drugs

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 a letter issued by the Veterinary Drugs Directorate.

NOTICE TO HOSPITALS
from the Veterinary Drugs Directorate

November 13, 2003

To: Hospital Chief of Medical Staff

Please forward to the Emergency Department and post this NOTICE in your institution.

Important safety information regarding fatal human reactions to the veterinary drug Micotil® (tilmicosin).

Dear healthcare professional:

This notice is intended for emergency room physicians who may ultimately be the primary care contacts. Health Canada is working in consultation with Elanco-Provel and we wish to apprise you of important safety information concerning Micotil® (tilmicosin) and the management of accidental human exposure.

Micotil® is a proprietary medicine for veterinary use produced by Eli Lilly and distributed by Elanco-Provel in Canada and is indicated for the treatment of bovine respiratory complex in beef cattle and the treatment of pasteurellosis in lambs.

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. For emergency treatment, dobutamine may partially offset the negative inotropic effects induced by Micotil® as evidenced in studies in dogs. DO NOT give -adrenergic antagonists such as propranolol as they may exacerbate the negative inotropy. In pigs it has been shown that epinephrine potentiates the lethality of Micotil®.

In keeping with our mandate to ensure public health, Health Canada's Veterinary Drugs Directorate is reminding veterinarians and health practitioners of the risk of cardiotoxic reactions and recommending strategies to manage such reactions should they arise.

Recommendations for the management of cardiac reactions associated with Micotil®

1. The patient should be on constant cardiac monitoring for an appropriate duration
2. In emergency situations, DO NOT GIVE EPINEPHRINE OR
   -ADRENERGIC ANTAGONISTS (such as propranolol)
3. Dobutamine may partially offset the negative inotropic effects induced by Micotil®

The identification, characterization and management of drug-related adverse events are dependent on the active participation of Healthcare Professionals in adverse event reporting programs. Healthcare Professionals are asked to report any suspected adverse events in patients accidentally receiving Micotil® to the Veterinary Drugs Directorate at the following address:

Pharmacovigilance Unit, Veterinary Drugs Directorate
Health Canada
Ground Floor, Suite 14
11 Holland Avenue, Holland Cross Complex
Ottawa, ON A.L. 3000A
K1A 0K9
or call toll free at 1-877-838-7322
fax: (613) 947-1125

Your professional commitment in this matter has an important role in protecting the well-being of your patients.

Please report any adverse drug reaction, or undesirable side effect from exposure to this drug to the Veterinary Drugs Directorate (VDD), at 1-877-vet-reac (1-877-838-7322). For product information, you can also contact Elanco-Provel at 1-800-265-5475.

Sincerely,

Diane Kirkpatrick
Director General, Veterinary Drugs Directorate

Any suspected human adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Therapeutic Products Directorate (TPD) Web site or in The Canadian Compendium of Pharmaceuticals and Specialties.