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Major Veterinary Drug Recall Gets Bigger

By Christie Keith on SFGate.com

Animal anesthetic drug pulled off market, but questions remain.

What if your veterinarian was using a recalled drug -- and didn't know it?

That's not a hypothetical question. On Sept. 4, 2009, 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 commonly used injectable veterinary drugs: butorphanol, a fast-acting opioid used to control pain from surgical procedures in dogs and cats, and the anesthetic agent ketamine.

Ketamine is part of a "cocktail" of drugs that induces anesthesia in animals, including dogs and cats. It can be used, usually with valium, prior to surgery, a dental cleaning and sometimes as a form of restraint for procedures such as an imaging scan. It's not the only drug that can be used in this way, but it's one of the most common.

The only explanation so far given as to just what's wrong with the recalled ketamine came in a press release issued by the FDA on Dec. 22, which said, "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."

Timeline of a recall

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.

Although it was the nation's largest manufacturer of generic animal drugs, almost no one in the veterinarian community had heard of Teva Animal Health until the FDA shut it down on July 31, citing adulterated drugs and multiple violations of good manufacturing practices at its St. Joseph, Mo., facility.

If you were a veterinarian or a member of the public, there was no further news about Teva until Dec. 22, when the FDA announced the company was recalling its injectable ketamine hydrochloride following the questionable deaths of five cats undergoing anesthesia with the drug.

It was obvious something else had occurred between the summer shutdown and Teva's announcement, however, because the FDA's recall notice referenced an earlier "distributor-level recall." But there was no copy of that recall notice on the FDA website, it didn't appear to have been published anywhere, nor could I locate a single veterinarian who had seen a copy.

If they had seen it, what happened a week later would have come as less of a surprise. On Dec. 29, Teva announced that the recall was extending to ketamine manufactured by Teva but sold under the brand names of some of the biggest players in the veterinary -- and human -- pharmaceutical world: Ketaset (Fort Dodge/Pfizer), KetaVed (VEDCO), KetaThesia (Butler), VetaKet (LLOYD Laboratories), Ketaject (Phoenix), Keta-Sthetic (RVX),and AmTech Group, Inc.

The information flow stops here

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)?

I contacted the FDA's Center for Veterinary Medicine about the earlier "distributor-level recall," and Laura Alvey, the agency's communications staff deputy director, e-mailed me a copy of the notice sent by Teva to its distributors.

That 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."

The letter also included this statement: "This recall is being conducted voluntarily and with the knowledge of the Food and Drug Administration." (Note: All recalls are voluntary, as the FDA does not have mandatory recall authority.)

That Sept. 4 distributor-only recall included all the brand name ketamine products not referenced until the second, "expanded" recall on Dec. 29, as well as the butorphanol recall that has still not been publicly announced.

"It's been extremely frustrating to veterinarians," said Jennifer Fiala, who has been investigating the recall for the Veterinary Information Network, or VIN, an online community and information database for veterinarians and veterinary students. "They're worried that the drug on their shelves is going to create an adverse event in the animals they treat."

That frustration is compounded by the fact that veterinarians have no way of knowing whether or not the drugs in their clinics were manufactured by Teva.

Alvey provided me with the federal government's labeling regulations for drugs. They're difficult to decipher, but buried in the text is the fact that drugs made by Company A and sold under the label of Company B can legally bear the label "Manufactured for Company B." The drug label does not have to include where, or by what company, a drug was actually produced.

Fiala finds that appalling. "Wouldn't it have been nice for a vet to be able to look at the label on a vial of Ketaset and see it was manufactured by Teva?" she said. "I can look at the label on my shirt and it will tell me it was made in China, but it can't say 'made in St. Joseph, Mo.' on a drug you're supposed to ingest or administer?"

2007 pet food recall redux?

This complaint probably sounds familiar to anyone who remembers the 2007 pet food recall, when questions about who made your pet's food, and whether any of its ingredients came from China, were impossible to determine from reading the label.

The 2007 pet food recall was also marked by enormous problems in obtaining information from the FDA. Many journalists and bloggers, including me, regularly reported recalls that the FDA did not announce until days or even weeks later -- a scenario that's playing out all over again today.

As of this writing, the ketamine recall information on the FDA's veterinary recall information page is limited to a link to the Dec. 21 notice.

The ketamine recall has not been mentioned on the FDA's much-hyped pet health alert widget, which has so far mostly been used to issue mundane pet holiday safety warnings.

There is also no sign of the Dec. 29 notice expanding the recall, although it was reported by Jennifer Fiala on VIN as well as on Pet Connection.

Nor did the FDA update its site with a list of recalled brands and their lot numbers, which can be found instead on VIN and on the site of the American Veterinary Medical Association.

Broken faith

Dr. Paul Pion, a veterinary cardiologist in Davis, and co-founder and president of VIN, deplores the faltering, sometimes dammed-up, flow of information from both the drug companies and the FDA.

"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."

That's a battle cry pet owners can rally behind, including the owner of a dog named Rogue, who lives in Washington state and asked that her name be withheld so as not to cause problems with her veterinarian, who is still caring for her dog.

"Rogue broke his tooth, and it became infected," she said. "In mid-December, I took him to the best veterinarian in our area, a specialist, and she scheduled him for surgery to remove the tooth."

Neither Rogue's owner nor the veterinarian cut any corners. At 10 years old, Rogue, a chow-chow, is considered a canine senior citizen, so he had what's known as a "geriatric panel," blood tests that screen for common old-age problems that might make anesthesia more risky for him than a younger dog.

"The vet listened to his heart with a stethoscope when she examined him before the surgery," his owner said. "He was fine. Everything came back normal."

But shortly after the veterinarian injected Rogue with a combination of ketamine and valium, his heartbeat became abnormal. She had to immediately abort the procedure and wake him up to protect his life.

Rogue was referred to a heart specialist, who diagnosed him with a serious condition known as a second-degree heart block. There's no way to know if the anesthesia caused the heart condition, or if it was the result of some previously undiagnosed problem. But when his owner heard about the ketamine recall on Dec. 22, she checked with her vet right away.

The veterinarian assured her that she hadn't used Teva's ketamine on Rogue, but Fort Dodge's Ketaset instead. Unfortunately, a few days later, Rogue's owner learned that brand, too, was being recalled. She followed up with a fax to her veterinarian asking about the expanded recall and what risk it might pose to her dog, but so far has had no response.

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."

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