FDA: Jurox voluntarily recalls two lots of Alfaxan after reports of adverse side effects, including one death
After receiving adverse reports involving five animals, Australia-based Jurox Animal Health voluntarily recalled two lots of the widely used intravenous injectable anesthetic Alfaxan unpreserved last week, according to the US Food and Drug Administration (FDA).
The reason for the recall: The presence of aluminum phosphate precipitate, which, when injected, presents a possible risk of blood vessel inflammation and formation of potentially life-threatening blood clots.
The recall is limited to lot numbers 27787 and 25955. Jurox received two adverse event reports for the former and one for the latter. Reasons for the reports included seizure, swelling of the conjunctiva, respiratory arrest, and one death.
NEWStat talked to Jim Van Proosdy, chief operating officer and country manager of Jurox US.
Although Van Proosdy was unable to go into detail (“The pertinent data that we’re able to discuss is all located on the FDA website”), he does emphasize that the issue is contained. “It’s limited to those two [lots], and they were produced quite a while ago.”
The lots were distributed in October of 2016 and April of 2017, respectively. That’s far enough back that most of the affected Alfaxan has likely been used already, a likelihood that Van Proosdy acknowledges: “We don’t even anticipate there being that much product out there,” he said. As for the decision to recall those lots, he said, “According to specifications, [the affected lots were] slightly out of spec, so we wanted to issue a voluntary recall.”
Is there any possibility that aluminum phosphate precipitate might have affected any other lots?
“No, none whatsoever,” Van Proosdy said. “They’re isolated incidents.”
Given that Jurox only issued the recall seven days ago, Van Proosdy said it’s too soon to tell how many vials will be returned: “It’ll probably take a week or two before people check their stocks and get the information back to us.”
So what should hospitals that discover unused vials of the affected Alfaxan in their inventory do?
Ralph Harvey, DVM, MS, DACVAA, retired professor of anesthesiology and pain management at the University of Tennessee College of Veterinary Medicine and a coauthor of the AAHA Anesthesia Guidelines for Dogs and Cats, told NEWStat, “My suggestion is for veterinarians to trust the process and follow directions regarding recalls in returning product.”
“And if [alternative anesthetics] are needed, I suggest returning to propofol or ketamine/propofol combinations,” Harvey added.
Alfaxan is packaged into 10mL stoppered and crimped vials. The details of affected batches can be identified on the vial label and also on the base of the outer carton.
The US is the only country affected.
Jurox said distributors and veterinarians that have any remaining vials of these two batches should quarantine the product to prevent use and contact Jurox by phone at either 816-698-6198 or 817-709-8845, Monday to Friday from 9 a.m. to 5 p.m. (CDT) to organize product replacement.
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