|"Only dull people are brilliant at breakfast"
|"The liberal soul shall be made fat, and he that watereth, shall be watered also himself."
-- Proverbs 11:25
The reported death of five cats prompted Teva Animal Health to widen its recall to include all vials of ketamine hydrochloride injection last week, yet the company’s technical services department insists that the action was caused merely by “increased medical events that were kind of unfounded.”
That statement, offered by a Teva technical services representative who did not give her name, has confused some veterinarians. On Dec. 22, the U.S. Food and Drug Administration (FDA) issued a recall alert, instructing practitioners to stop using all 27 lots of Teva’s ketamine hydrochloride injection, USP CIII 100 mg/ml in 10 ml vials due to “serious adverse events.”
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.
According to the FDA, reported problems with Teva’s ketamine include lack of effect, prolonged effect and death.
In response, practitioners have contacted the VIN News Service (VNS) looking for insight into the recall, which originated last summer and, at the time, took effect only at the wholesale level.
Troubles within Teva Animal Health surfaced in late July, when the FDA shut down the company via a permanent injunction and filed a lawsuit, alleging that regulatory inspectors had uncovered adulterated animal drugs at Teva’s main facilities in St. Joseph, Mo. The generics manufacturer agreed to cease production of its drugs and its DVM Pharmaceuticals line of products following a much-publicized crackdown by the FDA on the company’s quality control practices.
At the time, Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, stated: “The FDA will not tolerate the manufacture and distribution of adulterated animal drugs. Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”
But Laura Alvey, deputy director of communications with the FDA’s Center for Veterinary Medicine (CVM), notes in a recent interview with the VNS that, “FDA’s evaluation was that use or exposure to these products was not likely to cause adverse health consequences.”
To some, that assessment now appears flawed, considering veterinarians have been ordered to stop using Teva ketamine and to return it to their distributors because of the reported feline deaths.