Novartis Animal Health suspended production at its Lincoln, Nebraska, plant in December 2011 following a series of warnings from the U.S. Food and Drug Administration (FDA) regarding manufacturing and quality control violations. At that time, the only veterinary drugs affected were the heartworm and flea products Interceptor, Program, and Sentinel. Novartis said it hoped to return to full production in January.
Instead, further problems were discovered when Novartis warned veterinarians about possible tablet mix-ups in bottles of Clomicalm, used to treat separation anxiety. On January 5th, Novartis sent a letter to veterinarians informing them that it was suspending production and shipments of Clomicalm and Milbemite (used to treat ear mites) in addition to the products listed above.
Novartis resumed shipping already manufactured products in early February, but those have since run out, including supplies of Deramaxx, a non-steroidal anti-inflammatory drug (NSAID) whose production had been moved to the Nebraska facility shortly before the shutdown.
While substitutes for all of these products exist, it can be difficult for pet owners who rely on certain products that they know work well for their pets to suddenly have to make a change. The situation becomes even more stressful when using products such as NSAIDs, where it is unsafe to switch quickly from one to another without a washout period in between, or medications like Clomicalm that can take weeks to build up to effective levels in the blood.
Almost nine months after the initial announcement, the facility still has not resumed full production. Novartis says that it is now shipping the 5 mg strength of Clomicalm (the generic equivalent, clomipramine hydrochloride, is available in higher strengths elsewhere, including 1800petmeds.com). The company also states that it is at the testing pre-production stage for Sentinel, a combination of milbemycin oxime (heartworm preventive medication also found in Interceptor) and lufenuron (insect growth regulator used to control fleas, also found in Program), but they have not given an estimated date as to when this product will be available. Note that the Novartis veterinary products Atopica, Capstar, and Adequan are made at other facilities and are therefore not an issue.
In Canada, the situation is even more dire. Sandoz Canada, part of the generic pharmaceuticals division of Novartis, discontinued some medications and downsized production of others in response to FDA citations noting product reliability concerns and safety issues tied to the Sandoz plant in Boucherville, Quebec. A fire that broke out March 4 in the plant’s boiler room made the problem even worse. Affected drugs include morphine, fentanyl, phenobarbital, diazepam, and more. Sandoz has indicated that no human drugs will be delivered to veterinarians before the end of 2012, and vets are struggling to find acceptable alternatives.
– Mary Straus
For more information:
Novartis Animal Health, 800-332-2761, petwellness.com