Analysis of reports of human exposure to Micotil 300 (tilmicosin injection)

OBJECTIVE: To identify clinical signs associated with and outcome of human exposure to Micotil 300 (tilmicosin injection). DESIGN: Retrospective case series. STUDY POPULATION: Reports of 3,168 human exposures to Micotil 300. PROCEDURES: Reports of human exposure to Micotil 300 submitted to the Elanco Animal Health Pharmacovigilance Unit between March 1992 and March 2005 were reviewed. RESULTS: At least 1 clinical sign was described in 1,404 (44%) reports, whereas the remaining 1,764 (56%) exposures were presumably asymptomatic. Eighty percent of exposures involved males; mean age was 38 years. Sixty-one percent of exposures were a result of accidental injection, with injection site pain, bleeding, swelling, or inflammation being the most common signs, followed by nausea, tachycardia, dizziness, anxiety, an abnormal taste, headache, lightheadedness, limb pain, paresthesia, chest pain, and soreness. Only 156 (5%) reports involved serious adverse effects (ie, tachycardia, bradycardia, hypertension, hypotension, heart disorder, chest pain, tachypnea, or death). There were reports of 13 deaths following tilmicosin exposure, but only 2 of those deaths were related to accidental exposure. Time to onset of clinical signs was < or = 60 minutes in 63 of the 156 (40%) reports involving serious adverse effects. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that the overall risk of accidental human exposure to tilmicosin resulting in serious adverse effects is low (approx 2 people for every 1 million doses administered). Nevertheless, safe handling and proper use should be emphasized.