September 23, 2018
We would like to address any concern you may have about the recent FDA announcement regarding neurological side effects associated with the flea and tick preventatives we recommend: Bravecto and Nexgard.
The FDA has issued this alert in order to make pet owners and veterinarians aware that there may be neurological adverse effects (muscle tremors, ataxia (staggering) and seizures) for these medications. The reason that this alert is coming out now is because the potential side effects have been linked after the medications were approved and therefore these side effects are not on the medications’ labels. The manufactures will therefore need to update the label information to include these side effects.
All medications have side effects and side effects must be included in the medication’s label information. (The label information is on the folded up piece of paper that is included in the packaging that has all the ‘fine print’ on it.) In order to be approved by the FDA or Health Canada medications are carefully evaluated for safety. Once a new medication becomes available for widespread use it is still monitored carefully, especially for the first 3 years, as there is always the potential for new information to emerge once it is used in a larger population. If any new information comes to light (as in the case of possible neurological side effects in these drugs) then that information must be included on the label and pet owners and veterinarians need to be made aware of it. That is why this announcement was made; the safety of these medications has not changed.
In fact, part of the announcement stated: “The FDA carefully reviewed studies and other data on Bravecto, Credelio, Nexgard and Simparica prior to approval and these products continue to be safe and effective for the majority of animals.”
If you are feeling nervous about this announcement we would like to assure you that these medications continue to have a high margin of safety for the vast majority; nothing has changed in that regard. In a pet that has had a previous diagnosis of neurological disease we may now opt for an alternative flea & tick preventative for that individual. If you suspect an adverse reaction to any medication in your pet we encourage you to let us know so we may report it to the appropriate authorities.
All the vets and staff here at Central Nova Animal Hospital are still comfortable using Bravecto and Nexgard in our own pets and encourage you to be comfortable as well.