I have received Adverse Drug Event Reports from FDA for Bravecto, Nexgard, and Simparica, encompassing dates 10/16/2016 – 1/26/2017. 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) ADE Report
For this time period, there were 1,235 reports, including 1,131 for dog, 94 for cat, and 10 for human (accidental) exposure. The top 6 reported clinical signs for dogs are:
- Vomiting and Emesis (608)
- Lethargy (129)
- Diarrhea/Loose Stool/bloody diarrhea (151)
- Lack of efficacy (ectoparasites) (114)
- Anorexia/decreased appetite/not eating/inappetance (100)
- Seizure (43)
Deaths reported total 46 (death by euthanasia + death + 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 (224 dogs treated with fluralaner).
For cats (topical application of fluralaner), the top 6 reported clinicals signs are:
- Lethargy (12)
- Emesis/vomiting (13)
- Inappetance/anorexia/decreased appetite (12)
- Application site greasy/hair change/hair loss (17)
- Diarrhea (6)
- Ataxia (4)
Deaths reported total 2. The Bravecto topical product insert lists vomiting, pruritus, diarrhea, alopecia, decreased appetite, lethargy, scab and ulcerated lesions as the top adverse events noted in the field study (224 cats were treated).
Click this link to open the full Bravecto ADE report. Bravecto (Fluralaner) ADE Report Q4 2016
Nexgard (afoxolaner) ADE Report
For this time period, there were 703 reports, including 697 for dog, 4 for cat, and 2 for human (accidental) exposure. The top 6 reported clinical signs are:
- Vomiting/Emesis (402)
- Diarrhea/Loose Stool/Bloody Diarrhea (184)
- Lethargy (161)
- Itching/Pruritus/Generalized Itching/Scratching (160)
- Anorexia/Not eating/Inappetance/Appetite loss (136)
- Seizure (64)
Deaths reported total 28 (death + death by euthanasia).
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 adverse events in the pre-approval field study (415 dogs treated with afoxolaner). 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 Q4 2016
Simparica (sarolaner) ADE Report
In the U.S., Simparica received FDA approval on February 25, 2016, and this is the third ADE report I have requested for this drug. For this time period, there were 37 reports, including 36 for dog and 1 for human (accidental) exposure. The top 6 clinical signs reported are:
- Tremor (11)
- Lethargy (10)
- Seizure (9)
- Vomiting (8)
- Anorexia (7)
- Diarrhea (5)
Deaths reported total 3 (death + death by euthanasia).
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 Q4 2016