Ketamine and butorphanol recalls, FDA oversight, corporate responsibility and pet health
By now, some of you have heard the news that two common animal drugs manufactured by Teva Animal Health have been recalled. Unfortunately, my two in-house colleagues never got the memo on the toxicity tied to certain lots of these injectable drugs.
In fact, if I hadn’t checked our stash last month when fellow blogger Christie Keith called on this issue, our hospital might’ve still been dishing out potentially poisonous drugs without any inkling at all. Same goes for a wide margin of my veterinary compatriots.
This frightening news brought to you by concerned pet journalists and irate veterinarians across the U.S.
Because if it hadn’t been for their resounding WTF’s when they learned of the tainted drugs, the extent of the recall’s reach would have eluded us entirely. Here’s the deal, according to Christie Keith, fellow blogger and investigative animal health journalist in her latest piece for SF Gate:
What if your veterinarian was using a recalled drug -- and didn't know it?
That's not a hypothetical question. On Sept. 4 at least two veterinary drugs made by Teva Animal Health Inc. a division of Israeli-based Teva Pharmaceutical Industries were recalled by the FDA which shut the company down in July. But few veterinarians or pet owners were aware of the recall until the end of December.
Although the reported deaths of five cats led the FDA to issue public recall notices on Dec. 22 and Dec. 29, just what products are involved and over what time period they were manufactured and sold remains unclear.
The recalls involve two common veterinary drugs: Butorphanol, an opiate pain reliever, and ketamine, a dissociative anesthetic. Both are injectable preparations used frequently in anesthetic combinations. Which inevitably raises the question: What exactly is wrong with Teva’s drugs that led to the recall? Here’s the FDA’s response:
This recall is being conducted as a result of an increased trend in serious adverse events associated with this product including lack of effect prolonged effect and death.
Bad, yes. But we know it can happen. Nothing in life is 100% safe and the manufacturing process is fraught with many potential pitfalls. It’s the FDA’s job to suss out the bad apples when they happen by way of keeping the public safe. Unfortunately, that wasn’t entirely the case with this recall, given that the FDA issued this in a “recall alert” that only came out on December 22, 2009 –– months after the initial recall.
Sounds familiar, right?
It’s like the pet food recall all over again, some of us have been saying. Again, the problem has to do with the FDA’s system of “voluntary” recalls in which healthcare providers and the public need not always be alerted when a manufacturer issues a recall. In this current case, an extra dose of confusion was added to the mix when it became clear that Teva was manufacturing ketamine for a variety of brands, including Fort Dodge’s Ketaset, the most widely disseminated brand of ketamine in the veterinary marketplace (and the one we use, too).
Problem is, the FDA did not require Teva to make its problems known to those of us downstream. Although it did tell the companies whose ketamine it manufactured that there might be trouble in paradise, the FDA –– again –– did not require they disclose this information to veterinarians or to the public.
Because of the combined actions of the FDA and the companies responsible for manufacturing, marketing and distributing these drugs, the majority of the veterinary community is still in the dark.
Some of us have no idea that we should look askance at our hospital’s butorphanol and ketamine bottles. Unless we frequent VIN (the Veterinary Information Network) or keep tabs on our AVMA alerts, we’d probably never know since the distributors of the affected products have yet to inform us. And we don’t know the extent of the recall, though it may involve drugs manufactured as far back as 2006. Heck, it’s even unclear what clinical signs to look for –– never mind whether some of our poor-doers might have been affected by these suspect meds. Who knows?
What I DO know is that all my ketamine’s getting sent back. Every single bottle. Though the butorphanol we buy is free and clear, Fort Dodge’s Ketaset (which I use only very sparingly, anyway) is going back home to roost –– for good.
What’s more, I’m seriously rethinking which of Fort Dodge’s other products I can cut out of my arsenal. Because I’m not so sure I want to do business with a company that doesn’t think I deserve to know that I may hurt animals with the drugs and products it sells me.
After all, it’s one thing for the FDA to let me down (heck, I almost expect it these days), it’s quite another to know that a company I've always trusted to produce safe drugs for my patients would do us all so very wrong.