For Your Information: Facts About Tylosin

Tylosin is an antibiotic veterinary drug for the treatment of disease in food producing animals, including cattle, swine, and poultry, and for growth promotion in pigs. It has been approved in Canada for over 40 years.

In addition, this drug has been approved by regulatory agencies for disease prevention in food-producing animals in the United States, European Union (EU), Australia, New Zealand and several other countries. In 1999, the EU banned the use of tylosin for growth promotion in animals. However, the EU still endorses tylosin for therapeutic use and has also approved it for a wider variety of species than in Canada.

The product in question is a new application of tylosin, in conjunction with a growth hormone, for implantation in the ears of cattle. It was approved following a thorough evaluation by a team of Health Canada scientists in May 2002. In this particular case tylosin is used to reduce the incidence of abscess formation at the implantation site, i.e., it is used for therapeutic purposes and not for growth promotion. In this application, a minuscule amount of tylosin is included with the hormone to prevent infection around the animal's ear where the pellet is injected. It is for local use, and there is not enough antibiotic to get into the meat.

The elimination of the amount of tylosin in the implant from the ear of the animal takes about 18 hours. Cattle treated with implants would be slaughtered 100 to 150 days after the hormonal implantation. Consequently, the use of this antibiotic was considered not to pose any health hazard to humans.

Tylosin and the hormonal products have each been approved in Canada separately for use in cattle. Prior to its approval for sale in Canada, data from studies on dissolution and efficacy were taken into account and were considered to be satisfactory in confirming the human safety of this product. There is no scientific evidence that tylosin is carcinogenic. In addition, there is currently no scientific evidence showing that the therapeutic use of tylosin (as is the case in this application) causes an increase in resistance in bacteria to the drugs used in human medicine.

Health Canada reviews all veterinary drugs prior to their approval and release, including tylosin. Data for each drug is carefully reviewed by a team of scientists before the drug is approved for use. There is also a mandatory withdrawal period issued with each drug approval, when warranted, to prevent the exposure of humans to the residues of the drug. The Canadian Food Inspection Agency monitors meat for residues of veterinary drugs, including hormones.