I have received Adverse Drug Event Reports from FDA for Bravecto, Nexgard, and Simparica, encompassing dates 7/1/2016 – 10/15/2016. 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 time period, there were 1,875 reports, including 1,867 for dog, 4 for cat, and 4 for human (accidental) exposure. The top 6 reported clinical signs are:
- Vomiting and Emesis 787 reports
- Lethargy 244 reports
- Diarrhea/Loose Stool/bloody diarrhea 214 reports
- Lack of efficacy (ectoparasites) 181 reports
- Anorexia/decreased appetite/not eating/inappetance 207 reports
- Seizure 62 reports
Deaths reported total 38 (death by euthanasia + found dead + sudden death).
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. bravecto-fluralaner-ade-report-q3-2016
Nexgard (afoxolaner) Report:
For this time period, there were 1,573 reports, including 1,572 for dog and 1 for human (accidental) exposure. The top 6 reported clinical signs are:
- Vomiting 927 reports
- Lethargy 338 reports
- Diarrhea/Loose Stool/Bloody Diarrhea 406 reports
- Seizure 136 reports
- Itching/Pruritus/Generalized Itching/Scratching 520 reports
- Anorexia/Not eating/Decreased Appetite 318 reports
Deaths reported total 75 (death + death by euthanasia + sudden death).
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. nexgard-afoxolaner-ade-report-q3-2016
Simparica (sarolaner) Report:
In the U.S., Simparica received FDA approval on February 25, 2016, and this is the second ADE report I have requested for this drug. For this time period, there were 76 reports, including 75 for dog and 1 for cat exposure. The top 5 clinical signs reported are:
- Vomiting/Emesis/Blood in Vomit 53 reports
- Lethargy 33 reports
- Diarrhea/Loose Stool 27 reports
- Twitching/Ataxia/Seizure/Tremor/Convulsion 58 reports
- Not Eating/Decreased Appetite/Anorexia 27 reports
Deaths reported total 6 (death + death by euthanasia + unexplained death).
The Simparica product insert lists vomiting, diarrhea, lethargy, and inappetance as the top 4 clinical signs in the U.S. field study (315 dogs treated with Simparica). The insert also states “Simparica may cause abnormal neurologic signs such as tremors, decreased conscious proprioception, ataxia, decreased or absent menace, and/or seizures.”
Click this link to open the full Simparica ADE report. simparica-sarolaner-ade-report-q3-2016