Recent Changes In the ProHeart 6 RiskMAP
Florham Park, NJ (PRWEB) November 06, 2013 -- Zoetis Inc., a former business unit of Pfizer Inc., has announced revisions to the Risk Minimization Action Plan (RiskMAP) for ProHeart® 6 (moxidectin), the sustained-release injectable heartworm prevention medication for dogs. The revisions are based on a review of safety history over a 4½-year period. The updated RiskMAP permits administration by a trained, certified veterinary technician or assistant, removes the client consent signature requirement and allows use in healthy older dogs. Veterinarians can now offer six months of uninterrupted heartworm protection to all healthy dogs ages six months and older. These changes were agreed upon by the U.S. Food and Drug Administration’s Center for Veterinary Medicine and are now in effect.
“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.
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. 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.” More information on heartworm disease is available at http://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 (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: PROHEART 6 should be used in healthy dogs. Do not administer to sick, debilitated, underweight dogs or dogs that have a history of weight loss. Prior to administration, PROHEART 6 certified veterinarians should continue to assess patient health through a medical history, physical examination and if deemed appropriate, diagnostic testing. Continue to use caution when administering PROHEART 6 concurrently with vaccinations. Adverse events, including anaphylaxis, have been reported following the concomitant use of PROHEART 6 and vaccines. In some cases, anaphylactic reactions have resulted in death. Use with caution in dogs with pre-existing or uncontrolled allergic disease (food allergy, atopy or flea allergy dermatitis). Dogs receiving PROHEART 6 should be tested for existing heartworms as per the product label. In people, avoid PROHEART 6 contact with eyes. If contact with the eyes occurs, rinse thoroughly with water for 15 minutes and seek medical attention immediately. PROHEART 6 is available only to veterinarians through a restricted distribution program. Only certified veterinarians and staff can administer it. Click to obtain additional information including a copy of the product labeling 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 http://www.zoetis.com.
Zoetis is the proud sponsor with the Smithsonian Institution Traveling Exhibitions Service 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 more information, visit http://www.zoetis.com/animal-connections-tour/.
# # #
Liane Herman, Zoetis, +1 (973) 822-7180, [email protected]
Share this article