I have received Adverse Drug Event Reports from FDA for Bravecto, Nexgard, and Simparica, encompassing dates 4/1/2016 – 7/15/2016. 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 2,338 reports, including 2,335 for dog, 1 for cat, and 2 for human (accidental) exposure. The top 6 reported clinical signs are:
- Vomiting and Emesis 1,147 reports
- Lethargy 257 reports
- Diarrhea/Loose Stool/bloody diarrhea 279 reports
- Lack of efficacy (ectoparasites) 126 reports
- Anorexia/decreased appetite/not eating/inappetance 228 reports
- Seizure 68 reports
Deaths reported total 55 (death by euthanasia + death + 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 Q2 2016
Nexgard (afoxolaner) Report:
For this time period, there were 1,245 reports, including 1,244 for dog and 1 for human (accidental) exposure. The top 6 reports clinical signs are:
- Vomiting 399 reports
- Lethargy 196 reports
- Diarrhea/Loose Stool/Bloody Diarrhea 197 reports
- Seizure 78 reports
- Itching/Pruritus/Generalized Itching/Scratching 212 reports
- Anorexia/Not eating/Decreased Appetite 144 reports
Deaths reported total 27 (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 Q2 2016
Simparica (sarolaner) Report:
In the U.S., Simparica received FDA approval on February 25, 2016, and this is the first ADE report I have requested for this drug. For this time period, there were 27 reports, including 26 for dog and 1 for cat exposure. The top 5 clinical signs reported are:
- Vomiting/Emesis 12 reports
- Lethargy 8 reports
- Diarrhea/Bloody Diarrhea/Loose Stool 8 reports
- Twitching/Ataxia/Seizure/Tremor 13 reports
- Not Eating/Decreased Appetite/Anorexia 6 reports
There were no deaths reported.
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 Q2 2016