In the United States alone about 70 million doses of Trifexis have been dispensed and 15,000 veterinary clinics rely on the product. Elanco and the FDA conduct continuous, on-going monitoring on Trifexis, and all products, to determine if there are any signals or trends in the data, any increases in frequency of certain types of reports, etc.
We’ve seen no significant changes in reporting rate from year to year over the life of the product. In fact, we’ve recently completed a thorough review and analysis of Trifexis reports that mention death and have presented that to the FDA. There continues to be no established link between Trifexis use and death.
It’s critically important to understand that reports are not an indication of cause. For any given ADE report, there is no certainty that the reported drug caused the adverse event. The adverse event may have been related to an underlying disease, using other drugs at the same time, or other non-drug related causes. Anita Bergen’s case illustrates that a report is not necessarily an indication of cause. This case includes a number of other factors including a pre-existing, degenerative neurologic condition, long-term use of an untested, unapproved product and a diet lacking appropriate nutritional balance. Further, Scotties are naturally predisposed to several of the conditions listed in this case. The data suggests it’s unlikely there was any connection to the product in the pet’s unfortunate passing.
Also as we discussed, the data show this level of reports is similar for other products dispensed for heartworm prevention.