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Dr. Elizabeth Carney wants to empower YOU to take an active role in your pet’s health and well-being. After all no one knows your pet better than you!
FDA Issues Alert: Potential Neurologic Events Associated with Isoxazolines
On Thursday 9/20/18, the Food and Drug Administration Center for Veterinary Medicine (FDA CVM) issued an alert for pet owners about the isoxazoline class of drugs (including Bravecto, Nexgard, Simparica, and Credelio). According to the alert, the FDA has been monitoring post-marketing data, which indicates that some animals have experienced seizures, tremors, and ataxia after taking these products. Further, the FDA is working with the drug manufacturers to update each product's labeling to "highlight neurologic events because these events were seen consistently across the isoxazoline class of products." This statement in the alert caught my eye: "Although FDA scientists carefully evaluate an animal drug prior to approval, there is … [Read More...]
Bravecto, Nexgard, Simparica ADE Reports, Jan-Mar 2018
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. Bravecto (fluralaner) ADE report Q1 2018 Nexgard (afoxolaner) ADE report Q1 … [Read More...]
Bravecto, Nexgard, Simparica ADE Reports Oct-Dec 2017
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 (10/1/2017 through 12/31/2017), there were a total of 737 ADE reports received for afoxolaner for dogs, a total of 1191 ADE reports received for fluralaner for dogs, and a total of 429 ADE reports received for sarolaner for dogs." Bravecto (fluralaner) ADER Oct-Dec 2017 Nexgard (afoxolaner) ADER Oct-Dec 2017 Simparica (sarolaner) ADER Oct-Dec 2017 A reminder about how to use these reports (verbatim from the FDA Cover Letter): “More than one … [Read More...]
Bravecto, Nexgard, Simparica ADE Reports May-Sept 2017
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 (5/3/2017 through 9/30/2017), there were a total of 2243 ADE reports received for afoxolaner for dogs, a total of 3697 ADE reports received for fluralaner for dogs, and a total of 1126 ADE reports received for sarolaner for dogs." Bravecto (fluralaner) ADER May-Sept 2017 Nexgard (afoxolaner) ADER May-Sept 2017 Simparica (sarolaner) ADER May-Sept 2017 A reminder about how to use these reports (verbatim from the FDA cover letter): "More than … [Read More...]
Bravecto, Nexgard, Simparica ADE Reports: Q1 2017
I have received Adverse Drug Event Reports from FDA for Bravecto, Nexgard, and Simparica, encompassing dates 1/28/2017 - 5/2/2017. 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 … [Read More...]
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