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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Approves Drug to Prevent, Treat Vomiting in Dogs

by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No I

On February 28, 2007, the Food and Drug Administration announced the approval of two formulations of a new class of drug that is effective against certain causes of vomiting in dogs.

The tablet form of the new product, CERENIA™ (maropitant citrate), is approved for the prevention of acute vomiting, as well as vomiting due to motion sickness. CERENIA™ Injectable Solution is approved for the prevention and treatment of acute vomiting. Both products, which are made by Pfizer, Inc., are available only by order of a veterinarian.

According to Pfizer Animal Health market research, veterinarians see 30 cases of vomiting due to various causes per month on average, with an estimated 2.8 million dogs experiencing vomiting each year in the United States. Dogs undergoing cancer treatment or suffering from a paroviral infection, kidney disease, pancreatitis, and other ailments can suffer from acute vomiting, which can lead to weakness, dehydration, electrolyte imbalances, and even death.

In addition, another 1.2 million dogs suffer from vomiting caused by motion sickness. Motion sickness can be a major problem for dogs; some can become ill as quickly as 5 minutes after the start of a trip in a vehicle.

In one of the studies supporting the approval of the drug, CERENIA™ Injectable Solution was tested in dogs with cancer undergoing chemotherapeutic treatment with cisplatin, an agent that induces strong vomiting. In these trials, CERENIA™ Injectable Solution was 95 percent effective in preventing vomiting due to cisplatin.

As indicated in the product labeling, CERENIA™ is recommended for use in dogs 16 weeks of age and older. It is administered once a day, in either the tablet or the injectable form, to prevent acute vomiting for up to 5 days. To prevent vomiting due to motion sickness, the tablet(s) is to be given 2 hours prior to travel. Side effects observed during the company’s clinical trials using the tablets for the prevention of vomiting due to motion sickness include excessive salivation, vomiting not associated with motion sickness, and muscle tremors. Side effects observed during the company’s clinical trials using the tablet and the injectable for the prevention of acute vomiting include diarrhea and anorexia.

CERENIA™ has not been evaluated in dogs used for breeding, pregnant or lactating dogs, dogs with gastrointestinal obstruction, or dogs that have ingested toxins.

According to Pfizer, the new product will be available in the summer of 2007.