pet connection

So, is the AVMA’s take on the ketamine recall new information, a clarification, or spin?

A few minutes ago, I followed a tweet by @AVMAvets that read:

Butorphanol NOT affected by ketamine recall

The included link took me to an update on the AVMA website, which said:

Butorphanol is not affected by the expanded ketamine recall. Several butorphanol products manufactured by Teva Animal Health, Inc. were recalled as a precautionary measure at the distributor level in September 2009. Neither Teva Animal Health, Inc. nor the FDA Center for Veterinary Medicine has observed an increasing trend of adverse event reports associated with the use of these butorphanol products that would justify further action beyond the initial precautionary recall in September.

It is true that butorphanol has not been recalled beyond the distributor level, as ketamine has been. And it’s true, or at least, true as far as we know, that there have been no reports of adverse events associated with the recalled butorphanol.

Indeed, even the five cats whose deaths triggered the Dec. 22 ketamine recall and Dec. 29 expansion of that recall may not have died due to ketamine. We don’t know.

What we do know is this: Teva Animal Health, Inc. was shut down by the FDA on July 31 for a long list of problems (PDF) with their drugs, including “foreign material floating in” another injectable medication, non-sterile water used to formulate drugs, improperly formulated gentamicin sulfate (an antibiotic) and numerous other failures to properly manufacture drugs, including levothyroxine sodium, a thyroid supplement.

From that moment on, the FDA ordered them not to sell or distribute their drugs any more, to anyone.

On Sept. 4, Teva sent a letter to its distributors and recalled butorphanol and ketamine that they had in stock. This letter, entitled “Urgent Drug Recall,” instructed them to “cease distribution” of these drugs and stated that the FDA was aware of the recall.

Teva also told its distributors that they could recall product from the customers to whom they’d sold it — veterinarians — but it wasn’t required that they do so.

And they didn’t.

So I have a question for the AVMA: Don’t you think your member veterinarians should have been given this information about this “urgent drug recall” back in September, when the distributors were, and allowed to decide for themselves?

Why do the distributors get the “precautionary measure” of a recall, but not the veterinarians who are the ones giving these drugs to their patients?

Not to mention that I believe I have a right to know if my veterinarian is giving my pet recalled drugs from a company shut down by the FDA for adulterated drugs and bad manufacturing practices. I have a sneaking suspicion my veterinarian feels the same way.

Don’t you?

The amazing story of Druse the Dachshund: Although I have two longhaired dachshunds, I am not the type to proclaim them the best of all possible breeds.  Every dog is unique, just like us.  However, loyal reader  Snoopy’s Friend found a story from Der Spiegel Online (easier than flying to Germany, right?) about Druse the previously-lost Dachshund.  Druse didn’t just find her way home, oh no.  Those tales appear in the news every week.  Druse presented herself to her local lost and found center.   I don’t even know how that’s possible, but I do have to admit Cami’s and Harry’s wits are forever surprising me.  Great, now I learn they can probably read….

Ketamine recall:   The Teva Pharmaceuticals story is only getting worse, and of course we’re on it.   Nobody is doing a better job of keeping on top of the unfolding saga than our own Christie Keith.  Her most recent Pet Connection post on the case, in case you missed it, should be bookmarked (until the next one).    In that post is a link to her fuller SFGate column, which, if you haven’t seen it, is required reading.

This void of information, from the highest corporate levels of Big Pharma, to the halls of government, right down to the plight of a sick dog and his worried owner, does as much damage to public health as tainted food and drugs.

It does it by destroying trust. People lose faith in their doctors, pet owners lose faith in their veterinarians, and veterinarians and doctors as well as average citizens lose faith in agencies like the FDA, ostensibly tasked with protecting both human and animal health.

“The domino effect applies,” observed Fiala. “Everybody falls.”

It bears repeating: if your pet is going to be facing surgery, make sure both you and your veterinarian are fully up to speed on what is and is not considered safe right now (and be aware that today’s list might not be tomorrow’s).

Paying tribute to Zak the Police Dog: My eldest niece (I say “eldest” like she’s 80.  Leigh is in her 20’s) lives in Connecticut and was struck by the tribute to Zak, a German Shepherd who, by all reports, was a tremendous public servant.  Zak passed away suddenly on December 12, and all of Stratford’s official community came out to pay tribute, plus more.

Police from towns and cities across Connecticut and even New York, including 44 K-9 teams, plus a number of Stratford firefighters and town residents, attended Friday’s service for Zak to pay their respects.

The dogs’ barking mingled with the mournful wail of bagpipes in tribute to their fallen comrade, and some handlers and people in the audience brushed away tears during the ceremony.

If you’re up to it, a slideshow of Zak’s memorial service is here.   Thank you for your faithful service, Zak.  You were a very, very good dog.

Rescue dogs heading for Haiti: The nation of Haiti has been devastated by a massive earthquake. The country was environmentally damaged and crippled with poverty and corruption even before the powerful 7.0 quake destroyed what some estimate as half its buildings.

Haitian rescue organizations are overwhelmed, and many citizens are either dead or trapped under rubble. A number of nations, including France and the United States, are sending aid and other forms of assistance, including dogs specially trained to search for survivors in the aftermath of earthquakes.

From USA Today:

The United States and other nations began organizing aid efforts, alerting search teams and gathering supplies that will be badly needed in the Western Hemisphere’s poorest country. The International Federation of the Red Cross and other aid groups announced plans for major relief operations.

The U.S. Agency for International Development was dispatching a disaster response team and deploying search and rescue teams from Fairfax County, Va., and Los Angeles. The search teams include six sniffer dogs that can search for people trapped in wreckage.

The National Disaster Search Dog Foundation, “a non-profit organization whose mission is to strengthen America’s emergency response network by producing the most highly-trained canine-firefighter disaster search teams in the nation,” is also on its way to Haiti:

National Disaster Search Dog Foundation, a non-profit, non-governmental organization dedicated to recruiting rescued dogs and partnering them with firefighters to find people buried alive in the wreckage of disasters, today announced six Canine Search Teams are en route to Haiti to assist with search and rescue efforts in response to the powerful 7.0 earthquake that struck the island on January 12. The State Department, the U.S. Agency for International Development and the Office of Foreign Disaster Assistance are working in conjunction with California Task Force 2 (CA-TF2), a FEMA urban search and rescue task force based in Los Angeles County.

CA-TF2, which is sponsored by the Los Angeles County Fire Department, is one of two U.S. Task Forces charged with responding to international natural or man-made disasters. All six teams deploying with CA-TF2 were trained by the National Disaster Search Dog Foundation to find people buried alive under the wreckage of disasters.

“The Haitian government has requested assistance from the U.S. in responding to the most devastating earthquake to hit the island in 200 years,” said Debra Tosch, Executive Director of Search Dog Foundation. “We know that the first few hours after a major disaster has occurred are critical in saving lives and the search and recovery teams are in place now.”

Hope you caught that — these are rescue and shelter dogs on their way to help people in need. All of us at Pet Connection hope their mission is a successful one for the people of Haiti and these brave dogs and their handlers.

Got a tip?  Got a story?  Don’t keep it to yourself.  Send it to me, or give me a shout in the comments.

Photo credit: Doxie in field: DPA

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.

The FDA shutdown of Teva Animal Health last July was not the end of the story — and neither was a drug recall announced on Dec. 22 and expanded on Dec. 29.   A document released today by the FDA reveals that the recall is wider in scope than previously revealed. The drugs in questions  are commonly used in veterinary medicine to induce anesthesia and for pain control.

This is copy of a document (PDF) sent to Teva’s distributors on Sept. 4, 2009, more than three months before the recall was announced publicly, in which the drug company recalled not only Teva’s ketamine, but a number of brands manufactured by Teva for major drug companies, as well as a second drug, injectable butorphanol, which has not yet been publicly recalled.

The recalled drugs are:

Ketamine:

• Ketaset (Fort Dodge/Pfizer)
• KetaVed (VEDCO), KetaThesia (Butler)
• VetaKet (LLOYD Laboratories)
• Ketaject (Phoenix)
• Keta-Sthetic (RVX)
• AmTech Group, Inc.

Butorphanol:

• EQUANOL (VEDCO)
• ButorJect (Phoenix)
• TorphaJect (Butler)

This is the “distributor level recall” referenced in the FDA’s Dec. 22 announcement of the ketamine recall. The file came from deputy communications staffer Laura Alvey, in response to our inquiry to the FDA’s Center for Veterinary Medicine. She confirmed that “there was no expansion on the Butorphanol (recall) …  only the Ketamine products due to the increased trend in adverse events reported.”

I have a lengthy piece on the recall coming out on SFGate.com in the morning, and in the course of investigating, I discovered one other document, this one on the FDA website. It’s the FDA’s report (PDF) of the violations that led them to shut Teva’s plant in St. Joseph, Missouri down.

Those violations included “foreign material floating in” another injectable medication, non-sterile water used to formulate drugs, improperly formulated gentamicin sulfate (an antibiotic) and numerous other failures to properly manufacture drugs, including levothyroxine sodium, a thyroid supplement.

We’re still covering this. In the meantime, if you’re a pet-owner, you need to be talking to your veterinarian in advance of any surgery. If you’re a veterinarian, you need to be checking your inventory for recalled product.

The snowball keeps rolling downhill in the ongoing recall of ketamine, an anesthetic drug used in veterinary practice.

The story began last summer, when the FDA sued Teva Animal Health, the largest manufacturer of generic animal drugs in the United States, after agency inspections turned up adulterated animal drugs.

On Dec. 7, Teva reported to the FDA that it had begun receiving  reports dating back to November that as many as five cats may have died as a result of the affected ketamine. The FDA says it reviewed those reports on Dec. 11, and issued the following announcement on Dec. 21:

Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

[....] 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 and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

The Veterinary Information Network News Service followed up with an in-depth article on Dec. 29, saying that five cats may have died as a result of the compromised drug, and describing a quagmire of unanswered questions, confusing conversations with a Teva representative who refused to identify herself, and conflicting information about just what drugs were or weren’t involved.

From VIN News Service’s Jennifer Fiala:

The expiration dates of the lots range from September 2009 to February 2012, the FDA says. Additionally, the American Veterinary Medical Association (AVMA) warns practitioners not to rely on the Teva brand name to determine whether their ketamine falls under the recall. Rather, the following signs offer a better indication:

* If the lot number is six numeric digits, the product is not part of the recall.
* If the lot number is seven numeric digits, the product should be returned.
* If the lot number starts with 5401, regardless of the number of digits or the presence of letters in the lot code, the product should be returned.

This recall actually began last summer at the distributor level, following the filing of the FDA lawsuit and a subsequent FDA shutdown of Teva’s manufacturing facility in St. Joseph, Missouri.

Fiala’s report also raised the question as to whether Teva was manufacturing ketamine under other labels — a practice reminiscent of the 2007 pet food recall, when surprised pet owners learned that Menu Foods, a company few had ever even heard of, was manufacturing so many foods bearing other manufacturers’ names.

Today, that question was answered: yes, the Teva recall includes other brands, including Fort Dodge, one of the largest names in veterinary drug manufacturing, and that was acquired by Pfizer this fall. (Note: Pfizer is a sponsor of the Pet Connection newspaper feature’s database.)

The FDA’s Center for Veterinary Medicine today told the VIN News Service that affected labels include:

* AmTech Group Inc. Ketamine Hydrochloride Injection, USP, manufactured by IVX Animal Health Inc., St. Joseph, Mo.
* Butler KetaThesia, distributed exclusively by Butler Animal Health Supply, Dublin, Ohio
* Fort Dodge Ketaset, manufactured for Fort Dodge Animal Health, Fort Dodge, Iowa
* VEDCO KetaVed, distributed by Vedco Inc., St. Joseph, Mo.
* Phoenix Ketaject, manufactured for Phoenix Pharmaceutical Inc., St. Joseph, Mo.
* LLOYD Laboratories VetaKet, manufactured for Lloyd Laboratories in Shenandoah, Iowa
* RXV Keta-Sthetic, manufactured for RXVeterinary Products, Westlake, Texas

It’s crucial to note that veterinarians have had as much trouble getting answers about this recall as pet owners have. The problems with ketamine go back several weeks at least, and there’s no estimate how many animal may have been affected, or might be affected in the future — the inevitable outcome of slow, fragmented recalls with partial and often misleading information being dispensed both by industry and government.

It’s not likely there will be more information over the long holiday weekend, but we’ll keep watching the story as it develops. Gina is speaking with Joshua Sharfstein, the FDA Deputy Commissioner leading the agency’s transparency task force, on Monday — hopefully we’ll have more information for you then.

And kudos to Jennifer Fiala at VIN News Service for moving this story today. You can follow them on Twitter, subscribe to their RSS feed, or just plain old check their website to keep up with their coverage. Great work.