Here are the most recent reports from FDA.
From the FDA Cover Letter: “Afoxolaner and sarolaner are approved for oral use in dogs only. Fluralaner is approved for both oral use in dogs only and topical use in dogs and cats only. For the time period of the ADE database search (1/1/2018 to 3/31/2018), there were a total of 542 ADE reports received for afoxolaner for dogs, a total of 959 ADE reports received for fluralaner for dogs, and a total of 355 ADE reports received for sarolaner for dogs.”
Click on the link below to open the report. A new window will open. Click on the small document in the new window and it will open a larger version.
A reminder about how to use these reports (verbatim from the FDA Cover Letter):
“More than one clinical sign may have been reported per ADE case report, so the ‘Number of times reported’ column is not additive and does not necessarily represent the total number of reports received. Also, if a manufacturer reports multiple products in a single ADE case report, clinical signs are associated with each of the manufacturer’s products.”
“When reviewing the CVM ADE Comprehensive Clinical Detail Report Listing, the reader should be aware that:
- 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. The clinical detail 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.
- The accuracy of information regarding the ADE is dependent on the quality of information received from the reporting veterinarian or animal owner.
- Accumulated ADE reports should not be used to calculate incidence rates or estimates of drug risk, because there is no accurate way to determine how many animals were actually given the drug, which is needed as the denominator in calculations of incidence and relative risk.
- It is inappropriate to make use of adverse event data to compare the safety of different products. For example, if a drug is widely used to treat certain conditions, there may be more ADEs for that drug than another product that is not used as often. This would not mean that the first drug was more unsafe than the second. The number of reports simply represents the number of ADEs received for a particular drug and should not be used for any type of comparison purposes.
- Underreporting occurs with most adverse event reporting systems. The frequency of reporting for a given drug product varies over time, and may be greater when the drug is newly marketed, or when media publicity occurs.
Information on how the drugs were used (for indications on the product label or in an extra label manner) is not provided in the clinical detail listing.”