Major veterinary drug recall gets bigger
By Christie Keith
January 13, 2010
What if they recalled your pets’ drugs, and no one told your veterinarian?
That’s what’s happening right now, in a series of veterinary drug recalls that have been going on quietly, without public notice or so much as a letter to America’s veterinarians, since Sept. 4.
Although there have been reports of a Dec. 22 recall and Dec. 29 expanded recall of one drug, ketamine, both here and by the Veterinary Information Network’s News Service, an FDA document released yesterday revealed a number of details that had not previously been reported.
Two drugs, not one, were involved, and the recall itself began quietly more than 3 and a half months before a public recall notice was issued. Not even veterinarians were informed.
From my column this morning for SFGate.com:
Because pets are anesthetized more often than humans — for example, nearly all dogs and cats are spayed and neutered at a young age — the potential number of affected animals is huge. You’d expect, then, that veterinarians, the people who are buying and administering these drugs, would have been the first to learn that they were being recalled.
You’d be wrong.
[....]
Veterinarians, along with their patients’ owners, suddenly realized they were the last link in a mostly-broken chain of information emerging — or, more correctly, trickling out — from Teva, the companies for which it was manufacturing drugs, their distributors and the FDA.
There are many unanswered questions. For example, how far back in time did the recall extend? Dates listed on the site of the American Veterinary Medical Association suggest that the recalled ketamine has been distributed to veterinarians as early as 2006, a timeline confirmed by Denise Bradley, senior director of corporate communications for Teva.
Furthermore, why did it take so long to notify veterinarians about the ketamine recall, and why have they still not been notified about the butorphanol recall, which includes the brands EQUANOL (VEDCO), ButorJect (Phoenix) and TorphaJect (Butler)?
[A letter], signed by Joseph DelGobbo of Teva’s quality control department and dated Sept. 4, stated that the distributors were under no obligation to notify their customers — veterinarians — about the recall. “If you want to request return of product from your customers,” it read, “that is acceptable although not required.”
There’s more… a lot more. Including this from Dr. Paul Pion, co-founder and president of VIN, who does all of us who have worked with him over the years proud with this statement:
“Once it becomes clear there is a problem, all concern should turn to getting the information to veterinarians so they can do the right thing for their patients,” Pion said. “Everyone who has the information, whether they believe it’s their job or not, should share it.
“Damn the lawyers, corporate protocol, quarterly sales goals or fear of being blamed. Because the truth will ultimately be known, and any attempt to delay or sugarcoat the information serves only to dissipate confidence in the entire system. And any individual or company who has reliable information and doesn’t share it should be held personally and corporately responsible for any adverse reactions that occur after that.”
Amen, Paul.
Read the complete article here — and please, because this presents such a danger to so many pets whose veterinarians may still be unaware of the scope, both known and unknown, of this recall — tell your friends, and discuss it with your pets’ veterinarians.
Great job, as always. Thanks for sticking to this.
Comment by Kim Thornton — January 13, 2010 @ 8:14 am
Obviously, the vets that don’t know about the recall might still use the drugs.
How stupid is this system that allows the FDA to wait for the manufacturer to do the recalling and the notifying of all the vets concerned. It is beyond my comprehension that negligence or coverup still goes on, even after all those pets died in 2007 from the food poisoning.
Christie, you are the finest advocate I know for these types of recalls. I just know that you will keep watching the companies and letting us know and I am so greatful!
Comment by Evelyn — January 13, 2010 @ 9:53 am
Grateful instead of greatful—okay, folks?
Comment by Evelyn — January 13, 2010 @ 9:55 am
THANK YOU, Evelyn!
Comment by Christie Keith — January 13, 2010 @ 10:13 am
I agree, amen Paul and Christie, your article at SF Gate is fantastic and yes, this is akin to the problem we see with pet food companies also. There is this unspoken “honor system” between FDA and these companies and its gotta stop!
Comment by Sandi K — January 13, 2010 @ 10:37 am
Thank you SO much for helping to make this information more available. More people need to be aware.
Comment by Colleen Mihelich — January 13, 2010 @ 1:27 pm
The inadequacies of the system are mind boggling.
Comment by Phyllis DeGioia — January 13, 2010 @ 5:33 pm
My dog died on Dec 22nd 14 hours post surgery to remove part of a swallowed towel. The surgery went perfectly, the dog was in good condition and weight.
After I took him home he was still out of it and not really all “there”
some time around 3-5 AM he died, I got up at 8 AM and found him.
Now after reading this I wonder if the Ketamine my vet used might be at fault.
Comment by R — January 13, 2010 @ 10:14 pm
My vet said many vets didn’t know about the recall for months and that he learned about the butorphenol recall from Christie’s article.
Comment by Kim Thornton — January 14, 2010 @ 8:58 am
I have looked into the recall of butorphanol today. That part of the recall was a distributor level recall, which means that they had all of the distributors pull it from their shelves prior to sale. This is why the veterinarians weren’t notified directly.
Comment by Diana Duncan — January 14, 2010 @ 12:53 pm
Diana — that’s not correct. What FDA told me is that it was because they had no adverse events reported for the butorphanol, but they did for the ketamine. The recalled butorphanol wasn’t some isolated special pre-sales lot — if you take the time to read the PDF that I link to of the Sept. 4 butorphanol recall letter, some of that butorphanol was shipped all the way back in October of 2008… not last year, but nearly a year and a half ago!
Are you seriously suggesting it sat for a year and a half unsold in a warehouse just in case it was recalled in the future? It’s all set to expire this summer. Believe me, at least some of it, if not most of it, was sold long ago, and there is still no recall to the veterinarian level of it, nor even a public notice.
Comment by Christie Keith — January 14, 2010 @ 2:30 pm
I apologize for not being more clear in my comments…..I do agree with what you are saying. I was just posting the information I was given by our distributor. They were notified but as a distributor recall, not a customer recall. I checked all of our stock and we had none of these lot numbers. I agree that this is a mess….we may have had this and not known there was an issue with it.
Comment by Diana Duncan — January 14, 2010 @ 5:55 pm
I understand, Diana. The tragedy is that the distributors were not required to tell the vets, and so most of them didn’t, and then they used that as an “explanation” of why they didn’t. But common sense and integrity would dictate that they SHOULD have told their customers back in September. They may not have been required to, but they should have done it anyway.
And the law SHOULD require them to, even if it currently doesn’t. This is really wrong. :(
Comment by Christie Keith — January 14, 2010 @ 6:30 pm
I don’t know when or why it disappeared, but integrity seems to be in short supply these days.
Comment by Kim Thornton — January 14, 2010 @ 9:18 pm
Would Dr. Pion’s quote, starting with the “damn the lawyers…” fit on a bumper sticker?
Tylenol recall got me ranting again this AM ;)
Comment by cb — January 16, 2010 @ 11:46 am
It’s now human drugs, as well:
Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B
Comment by Lis — January 18, 2010 @ 7:38 am
Interesting … from last July, and another “voluntary” recall. The FDA needs MANDATORY recall authority! Grrrr!
Comment by Gina Spadafori — January 18, 2010 @ 8:00 am
Its interesting, I just saw on CNN where Dr. Sanjay Gupta said that one of the drugs they are using in Haiti for amputations is ketamine…
Comment by Sandi K — January 18, 2010 @ 8:35 pm
I hope they didn’t get it from the bargain bin at the distributor. :(
Comment by Gina Spadafori — January 18, 2010 @ 8:42 pm