By Christie Keith
December 31, 2009
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 receivingÂ 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 FDAâ€™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 agencyâ€™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.