Prescriptions for Healthier Animals : Distressed Dogs and Separation Anxiety

by Food and Drug Administration (FDA)

(Page 3 of 3)

The only other FDA-approved drug for animal behavioral problems currently on the market is Clomicalm, manufactured by Novartis Animal Health US, Inc., of Greensboro, N.C. Clomicalm is to be used as part of a behavior modification program to treat separation anxiety in dogs older than six months.

Although not a tranquilizer, Clomicalm can lessen anxiety by increasing the serotonin levels in the brain. Increased serotonin can make a dog more receptive to positive behavior modification and less likely to overreact to an owner's absence.

While few dogs are happy when their owners leave, some show extreme anxiety, resulting in destructive behavior, soiling the house, excessive salivation, or constant barking and whining. In severe cases, dogs mutilate themselves, eat furniture, jump through windows, or claw through walls.

"If your dog is tunneling through your wall, that dog is going to be dead soon," says Overall, who sees many rescued dogs with separation anxiety in her clinic. She attributes these cases in part to the "pet recycling" process. "Cute animals get adopted, they go home, they don't behave as expected so they go back, get readopted, and go home again. As they get recycled, separation anxiety increases."

Overall cautions owners that they cannot simply pop a pill in their pet's mouth and expect to come home to a perfectly calm dog and intact house. Treating a dog for separation anxiety requires hard work on the part of the whole family to modify the pet's behavior. "I know everybody wants magic from science, but I try to get across to my clients that you're not going to solve anything with just a pill," says Overall. "The people who work the hardest get the biggest change — regardless of the severity of the condition."

Whitley, a mixed terrier-poodle, is a testimony to the success of behavior modification combined with medication. The 10-year-old dog, known for her spirited but sweet disposition, suddenly became anxious and destructive after her owner left for work. "She chewed up clothes, doors, furniture, and electrical cabling — to the point where her gums were bleeding," says owner Mark Oumedian of Livonia, Mich.

Under the supervision of his veterinarian, Oumedian put Whitley on Clomicalm. At the same time, he practiced behavior modification techniques — exercises to help learn positive behaviors — with Whitley. But Whitley went through an entire bottle of Clomicalm with no effect. Oumedian's initial discouragement turned to delight when halfway through the second bottle — about 45 days after the dog began taking the drug — Whitley started to show results. Soon after, he became a happy, well-adjusted pooch once again.

And Oumedian was relieved that his spunky dog's character remained unchanged. "It was so amazing to me that there were no personality changes or side effects," he said. "It would have broken my heart if there were."

Animal behaviorist Dodman emphasizes the grim consequences of behavior problems. "Behavior problems are probably the leading cause of mortality in the canine population," he says. "It's estimated that at least one-and-a-half million dogs are needlessly euthanatized each year because of behavior problems, which is three times as many as die of cancer."

Some veterinarians predict that the use of drugs for behavioral problems will result in a decrease in the number of animals euthanized or relinquished to shelters. "Oftentimes, success in treating a behavioral problem like separation anxiety can mean the difference between having to put an animal to sleep or being able to live with the pet," says Stephen Sundlof, DVM, director of FDA's CVM . "Having drugs like this available can really make a tremendous difference."

New psychotropic drugs to treat animal behavioral problems and geriatric conditions may be just ahead. Meanwhile, pets can continue to have the best of both worlds — a host of human and animal drugs to treat their ailments and keep them healthy and active for many years.

Vet Medicine Promotes Progress in Human Medicine

While advances in human medicine can mean new drugs to treat pets, veterinary medical advances can also benefit humans. The creation of a blood substitute is an example of this potential. Scientists have been searching for an effective oxygen-carrying blood substitute for more than 50 years.

In 1998, FDA approved Oxyglobin, the first blood substitute to reach the market, for the treatment of anemia in dogs. Anemia, a deficiency of red blood cells or the protein hemoglobin within red blood cells, kills millions of dogs each year. Treatment for canine anemia is difficult because of the lack of donated dog blood, the resources required to refrigerate the blood for storage and warm it prior to use, and the need to use it within its 35-day shelf life. Also, typing and cross-matching must be done to accommodate the eight blood types of dogs.

Oxyglobin is the first alternative solution to donated blood. A chemically modified bovine hemoglobin solution, Oxyglobin picks up oxygen in the lungs and carries it to cells throughout the body. "The product quickly delivers oxygen into tissue and organs and buys time for the dog's own regenerative red blood cells to come back," says Robert Murtaugh, DVM, principal investigator for the canine clinical trials at Tufts University School of Veterinary Medicine.

Biopure Corp., the manufacturer of Oxyglobin, along with Tufts University, is testing a similar blood substitute, Hemopure, for humans as a treatment for sickle cell anemia and as a replacement for donated blood during surgery. Unlike stored blood, Hemopure requires no refrigeration, is compatible with all blood types, and has minimal potential to transmit viruses or bacteria.

FDA's Center for Biologics and Evaluation (CBER) is currently evaluating this human blood substitute to determine its safety and effectiveness. "Hemopure is subjected to a higher level of scrutiny," says Abdu Alayash, Ph.D., a research chemist in CBER, "particularly in light of recent clinical failures with other hemoglobin-based products intended for human use."

The implications of a human blood substitute are significant: Emergency medical personnel can carry out transfusions in the field, for example at the site of an accident or in a war zone, without the worry of blood-typing, cross-matching, or transmitting infectious diseases.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.