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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter March/April 1999 Volume XIV, No II

FDA's Center for Veterinary Medicine (CVM) has approved two drugs to treat two different behavioral problems affecting some dogs. These drugs are ClomicalmTM Tablets (clomipramine hydrochloride) to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than six months of age, and Anipryl® Tablets (selegiline hydrochloride, L-deprenyl hydrochloride) to control the clinical signs associated with canine Cognitive Dysfunction Syndrome (CDS).

Separation anxiety is a complex behavior disorder displayed when the owner or someone the dog is attached to leaves the dog. Dogs with separation anxiety may exhibit one or more of the following clinical signs: barking, destructive behavior, excessive salivation, and inappropriate elimination. Proper recognition of clinical signs, which comes from compiling a complete patient history and assessment of the dog's household environment, is essential to accurately diagnose and treat separation anxiety.

In clinical trials, ClomicalmTM Tablets, when used with behavior modification, were shown to reduce the signs of separation anxiety and increase the rate of improvement when compared to behavior modification alone.

Anipryl® Tablets control clinical signs of CDS, an age-related deterioration typified by multiple cognitive impairments which affect the dog's ability to function normally. Behavioral changes associated with CDS include disorientation, decreased activity level, abnormal sleep wake cycles, loss of house training, decreased or altered responsiveness to family members, and decreased or altered greeting behavior. In clinical trials, Anipryl® was shown to be effective in controlling clinical signs associated with CDS. However, onset, duration and magnitude of response varied with individual dogs.

The diagnosis of CDS in dogs is a diagnosis of exclusion, based on thorough behavioral and medical histories, in conjunction with appropriate testing and diagnosis. Periodic patient monitoring to evaluate the response and tolerance to the drug and for the presence of concurrent or emergent disease is recommended.

While ClomicalmTM Tablets and Anipryl® Tablets are safe for use in dogs at the recommended dosages, both products can cause side effects. The package inserts for both products also carry important Warning, Contraindication, and Precaution statements that should be considered prior to treatment. An important example is the fact that a dog should not be on both ClomicalmTM Tablets and Anipryl® Tablets at the same time. The use of these products together is contraindicated. A close veterinarian-client-patient relationship is recommended in order to monitor response to therapy and to watch for any side effects.

ClomicalmTM Tablets will be sold by Novartis Animal Health US, Inc. of Greensboro, NC. Anipryl® will be sold by Pfizer Animal Health, Inc. of Exton, PA. Both drugs will be available in tablet form and only on the order of a licensed veterinarian.