I have received Adverse Drug Event Reports from FDA for Bravecto and Nexgard, encompassing dates January 7, 2016 through March 31, 2016. Below is a reminder about how to read and use these reports; this is text taken verbatim from the beginning of the report.
- 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.
Bravecto (Fluralaner) Report
For this 3 month time period, the top 6 reported clinical signs are as follows:
- Vomiting and Emesis 422 reports
- Lethargy 93 reports
- Diarrhea 67 reports
- Anorexia and Decreased appetite 58 reports
- Lack of efficacy (ectoparasites) 26 reports
- Seizure 22 reports
The Bravecto product insert lists vomiting, decreased appetite, diarrhea, and lethargy as the top 4 clinical signs seen in the pre-approval field study.
Click this link to open the full Bravecto ADE report. ADE Report Bravecto Jan-Mar 2016
Nexgard (Afoxolaner) Report
For this 3 month time period, the top 6 reported clinical signs are as follows.
- Vomiting 135 reports
- Lethargy 50 reports
- Diarrhea 43 reports
- Pruritus/generalized itching/itching 70 reports
- Not eating/anorexia/appetite loss 47 reports
- Seizure 22 reports
The Nexgard product insert lists vomiting (with and without blood), dry flaky skin, diarrhea (with and without blood), lethargy, and anorexia as the top 5 clinical signs in the pre-approval field study. The product insert also contains a caution about use in dogs with a history of seizures.
Click this link to open the full Nexgard ADE report. ADE Report Nexgard Jan-Mar 2016