Ketamine
Bits & Pieces
The "Bits & Pieces" section is intended for random snippets of information which don't fit
easily elsewhere and/or which have been newly added, but not yet carefully categorized.
easily elsewhere and/or which have been newly added, but not yet carefully categorized.
- 2009 Product Recall #On September 4, 2009, a voluntary nationwide recall of ketamine and butorphanol manufactured by the company Teva Animal Health, Inc. was initiated by the FDA. The recall was at least in part instigated in response to the death of five cats that had been given the drug. An FDA press release on December 21, 2009, notes:
"[...] Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates [...] had previously been recalled to the distributor level and [the recall] 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."
The expiration dates of the ketamine lots recalled ranges from September 2009 to February 2012, and these products had been distributed to veterinarians as early as 2006.
As Teva manufactured the chemical for other companies selling ketamine, the recall affects these products as well: Ketaset (Fort Dodge/Pfizer), KetaVed (VEDCO), KetaThesia (Butler), VetaKet (LLOYD Laboratories), Ketaject (Phoenix), Keta-Sthetic (RVX), and AmTech Group, Inc. The American Veterinary Medical Association added the following information: 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.
Teva has not pointedly stated why the material was being recalled. However, in response to one anesthesiologist's speculation that perhaps the mixture of sterioisomers in Teva's material might not be a balanced 50/50 racemic mix (causing it to be more or less potent, depending on how much of the S(+) isomer is present), a Teva representative stated, "It's nothing with the drug. It's not super-potent." If that is true, another speculation is that the material contained a contaminant of some sort.
Previously in 2009, the FDA announced that on July 31 they had filed a consent decree of permanent injunction prohibiting Teva Animal Health, Inc., its president, and two principals from its parent company, from manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established and an independent expert inspects the facilities and procedures and certifies that they comply with current Good Manufacturing Practice (cGMP) and obtain FDA approval. During FDA inspections between 2007 and 2009, significant cGMP violations were discovered at Teva's facilities. (As of May 1, 2012, Teva was still working on upgrading their facilities in order to become cGMP compliant, and they only currently offer dermatological and nutritional products.)
This is of particular note because veterinary ketamine is sometimes diverted for recreational use by humans, and because humans often continue to use medications beyond their expiration dates.
- LozengeKetamine is available in as an oral lozenge for pain management. We have heard of it being prescribed to treat breakout pain resulting from deep tissue massage.
- LotionKetamine is available in topical lotions for use with chronic pain such as herniated discs. Such lotions, which may be compounded by licensed pharmacies, has at times been diverted for recreational use used via an enema.
- Nasal SprayKetamine nasal spray are sometimes used medically to complement severe pain management strategies. Although we don't know of any commercially produced products, it can be easily compounded by licensed pharmacies from the normal commercial solutions. It is commonly compounded in a 10% ketamine solution.