Medicines: Stricter rules for the veterinary medicine Micotil

Two US farmers died from accidentally self-injectioning the veterinary medicine “Tilmicosin” while treating their cows. These accidents have led the European Commission to tighten the rules for its use in the EU. “Tilmicosin” is marketed under the brand name “Micotil” in fifteen Member States^[1]. In order to prevent such fatal events in the EU, the Commission has decided to harmonise and strengthen the warnings in the product information. In addition, following scientific advice, Micotil can only be administered by veterinarians in future. Tilmicosin is an antimicrobial substance used exclusively in animals to treat respiratory diseases such as pneumonia in cattle and sheep

Further to the Commission decision, in the EU, the product information for tilmicosin shall include the following harmonised, stringent user safety warnings:

General recommendations:

Clear warning that injection of the product in human beings has been associated with fatalities;
In case of human injection, seek immediate medical attention and provide the physician with the vial or the package leaflet/product information.

Instructions to the person administrating the product:

Instructions for safer handling of the product:
Do not use automatic injection equipment;
Always detached syringe from needle during transport;
Use different needles for loading a syringe and injecting into an animal;
Do not inject more than 20ml of tilmicosin per injection site;
Instructions to always properly restrain animal(s) to be treated from the others in the vicinity;
Instructions to never work alone.

Note to the physician that might face a case of injection:

Details of the cardio-vascular effects of tilmicosin in human beings;
Treatments that are formally contra-indicated in case of suspicion of a case of self-injection with tilmicosin;
Administration of substances that may partially counter certain effects of Tilmicosin and help the recovery;
Advice to discuss clinical management of cases with national poison centres (telephone number of national centres provided).

In addition, the Commission decision further harmonised the conditions of use of the product, by classifying it as a prescription only medicine (i.e users can only obtain it on the basis of a veterinary prescription) and by restricting its use and administration by veterinarians only.
The Commission decision is available at:

http://ec.europa.eu/enterprise/pharmaceuticals/register/newproc.htm

^[1] Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, the Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom