United States

Recent Changes In The ProHeart 6 RiskMAP

FLORHAM PARK, N.J., Aug. 28, 2013 – Zoetis Inc., a former business unit of Pfizer Inc., announced today revisions to the Risk Minimization Action Plan (RiskMAP) for ProHeart® 6 (moxidectin), the sustained-release injectable heartworm preventive for dogs. The revisions are based on a review of safety history over a 4½-year period. The updated RiskMAP allows use in healthy dogs older than 7 years, permits administration by a trained, certified veterinary technician or assistant and removes the client consent signature requirement. The changes take effect immediately.

“We are very pleased that the predictable performance of ProHeart 6 has made revisions to the RiskMAP appropriate at this time,” said J. Michael McFarland, DVM, DABVP and group director of Companion Animal Veterinary Operations for Zoetis. “Veterinarians can now offer six months of uninterrupted heartworm protection to all healthy dogs ages 6 months and older, and provide greater peace of mind to their owners.

“Although significant restrictions have been lifted, Zoetis remains committed to education on the proper use of ProHeart 6 and will continue to uphold the guidelines set forth by the FDA to help assure that veterinarians and, through them, pet owners are aware of the benefits and risks of this product,” McFarland added.

The purpose of a RiskMAP for ProHeart 6 is to ensure safe, appropriate use to achieve maximum benefits of heartworm prevention while minimizing risk to dogs. The revisions to the RiskMAP are based on adverse event reports collected between June 1, 2008, and December 31, 2012. A steady and dramatic increase in ProHeart 6 use occurred during this 4½-year period with ProHeart 6 demonstrating predictable safety and efficacy that remained consistent as use increased. These data show that ProHeart 6 is a safe and effective product for the prevention of canine heartworm disease for six full months in dogs age 6 months and older

Heartworm Is a Pervasive Threat

According to the American Heartworm Society (AHS), “Heartworm disease is one of the major health problems of dogs in the United States and throughout the temperate and tropical areas of the world…The disease develops when a pet becomes infected with parasites called Dirofilaria immitis that are transmitted through the bite of an infected mosquito. Dogs may be infected by a few or up to several hundred heartworms. Heartworm infection often leads to severe lung disease and heart failure and can damage other organs in the body as well.”

The AHS urges pet owners to protect their pets. “Because heartworm disease is preventable, the AHS recommends that pet owners take steps now to talk to their veterinarian about how to best protect their pets from this dangerous disease. Heartworm prevention is safe, easy and inexpensive. While treatment for heartworm disease in dogs is possible, it is a complicated and expensive process, taking weeks for infected animals to recover.”1

Additionally, a 2009 study by the American Animal Hospital Association found that of pets that are on preventive heartworm programs, only slightly more than half—51 percent—of pet owners nationwide were current with their pets’ heartworm medication. This leaves 49 percent of pets at risk to develop heartworm disease. According to the AHS “heartworm disease can cause damage to the heart, blood vessels and lungs. If not treated, this can lead to serious, even life-threatening disease.”2 More information on heartworm disease is available at www.heartwormsociety.org.

About ProHeart 6

ProHeart 6 is a veterinarian-administered injectable parasiticide for dogs that provides six months of heartworm prevention, as well as treatment for common hookworm infections

1 American Heartworm Society website, “Pet Owner Resources: What Is Heartworm Disease?”, http://www.heartwormsociety.org/pet-owner-resources/heartworm.html
2 “Compliance: Taking Quality Care To the Next Level”, A Report of the 2009 AAHA Compliance Follow-Up Study, American Animal Hospital Association

(Ancylostoma caninum and Uncinaria stenocephala) existing at the time of administration. Just one injection protects dogs for six full months, replacing the need for monthly dosing.

Important Safety Information

Do not administer ProHeart 6 to sick, debilitated or underweight dogs, or dogs that have a history of weight loss. Use with caution in dogs with pre-existing or uncontrolled allergic disease. Some dogs show mild, transient swelling or itching at the injection site. Owners should be given the Client Information Sheet for ProHeart 6 before the drug is administered, and observe their dog for potential drug toxicity and allergic reactions described in the sheet, including anaphylaxis. Animals showing signs of drug toxicity or allergic reactions should receive immediate veterinary assistance. In people, avoid ProHeart 6 contact with the eyes. If contact with the eyes occurs, rinse thoroughly with water for 15 minutes and seek medical attention immediately. ProHeart 6 is available only through a restricted distribution program. Veterinarians enrolled in this program can receive and administer ProHeart 6. To obtain additional information including a copy of the product labeling or full Prescribing Information, visit www.ProHeart6dvm.com or call 1-888-ZOETIS1 (963-8471).

About Zoetis

Zoetis (zō-EH-tis) is the leading animal health company, dedicated to supporting its customers and their businesses. Building on a 60-year history as the animal health business of Pfizer, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services with a focus on both farm and companion animals. In 2012, the company generated annual revenues of $4.3 billion. With approximately 9,300 employees worldwide at the beginning of 2013, Zoetis has a local presence in approximately 70 countries, including 29 manufacturing facilities in 11 countries. Its products serve veterinarians, livestock producers and people who raise and care for farm and companion animals in 120 countries. For more information on the company, visit www.zoetis.com.

Zoetis is the proud sponsor with the Smithsonian Institution Traveling Exhibitions and the American Veterinary Medical Association of the mobile educational exhibit Animal Connections: Our Journey Together. Families visiting the exhibit will explore the vast bonds between people and animals and learn about the important role veterinarians play in protecting animal and human health. 
 
For further information, Contact:

Liane Herman
Zoetis
973-822-7180
Liane.Herman@zoetis.com

Julie Lux
archer>malmo
901-500-7063
jlux@archermalmo.com