A note from Jim Strickland about the FDA Documents

by: Jim Strickland Updated:

Channel 2’s Jim Strickland, through a Freedom of Information Act request, obtained two documents from the FDA never before made public.  They are the Adverse Drug Experience (ADE) Clinical Detail reports on the combination of Spinosad (flea) and Milbemycin Oxime (heartworm) found in Trifexis. 

This combination is patented by Elanco, and Trifexis is the brand name.  It is also marketed under the private label ComboGuard, sold at VCA veterinary clinics.

The STARS database report contains information filed on paper.  The numbers of note begin at the bottom of page 1 of 9, for dogs with an oral (pill) administration.

The PV Works database report is much more extensive, because it includes the electronic reports forwarded to FDA by Elanco.  The reports for dogs with oral administration begin on page 7.  A few reports in which the route of administration was missing begins on page 4. 

The following information is taken from the FDA website:

The primary purpose for maintaining the CVM ADE database is to provide an early warning or signaling system to CVM for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals. Information from these ADE reports is coded and entered into a computerized FDA/CVM ADE database.

CVM scientists use the ADE database to make decisions about product safety which may include changes to the label or other regulatory action.

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.

And, this listing does not include information about underlying diseases, other drugs used at the same time, other non-drug related causes, or the final outcome of the reaction.


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