OVERLAND PARK, Kan., Sept. 3 /PRNewswire-FirstCall/ -- Fort Dodge Animal Health, a division of Wyeth , announced today that it will voluntarily comply with the U.S. Food and Drug Administration Center for Veterinary Medicine’s request to temporarily cease production and recall ProHeart(R)6, a heartworm preventative, from the market until the FDA’s questions regarding safety are resolved. Fort Dodge Animal Health also announced its support for FDA’s formation of an independent Advisory Panel to review safety data on ProHeart 6. The panel will review safety data based on reports submitted through FDA’s voluntary self-reporting system.
While Fort Dodge Animal Health is cooperating with FDA’s request for a recall, we have concerns about how the agency interpreted these complex data. As such, the Company fully supports the initiation of this review process, and will work closely with FDA to provide any necessary information for the panel to make a fair and accurate assessment of these data. We look forward to working with the panel and remain confident in the safety and efficacy of ProHeart 6.
Based on a thorough evaluation of FDA’s data, and consultation with independent experts in veterinary medicine and epidemiology, Fort Dodge Animal Health stands behind ProHeart 6, which plays a vital role in preventing heartworm disease. This life-threatening disease is one of the most common and dangerous parasites for dogs, and impacted nearly a quarter of a million dogs in 2001.
“Our first and foremost concern is providing safe and effective products to ensure the health and well being of all pets,” said Dr. Rami Cobb, vice president of pharmaceutical research and development for Fort Dodge. “We take each and every adverse event report very seriously and evaluate them thoroughly, regardless of whether or not the product appears to be involved.”
It is important to recognize that all potential adverse events reported to the FDA are “unfiltered,” meaning all reported potential events are submitted without regard to cause, and cases subsequently determined not to be related to the product are still included in the overall reporting numbers. A thorough evaluation of the data indicates that the incidence of disease and death seen with the use of ProHeart 6 is at or below the baseline (the normal number that would be expected) for the U.S. canine population. Specifically:
* The overall incidence of adverse events represent less than one half of one percent of the more than 18 million doses have been sold to veterinarians. * For hematologic and autoimmune signs, the incidence rate is one in 31,000 doses, well below the baseline for the U.S. canine population. * The average age for liver signs in ProHeart 6 reports is within the range reported in the general canine population. About Heartworm Disease
Heartworm disease is one of the most deadly diseases affecting the U.S. canine population. ProHeart 6 is the only heartworm preventative that provides six months of continuous protection in one dose. Other heartworm medications include oral and topical formulations that must be administered monthly. With these medications compliance is often an issue as many pet owners forget to dose their dog regularly. Approximately 80 percent of all pet owners are, at one time or another, out of compliance with proper administration of heartworm preventatives. Because only a veterinarian can administer ProHeart 6, the risk of poor compliance is greatly reduced. Of more concern is that 20 percent of dogs who miss their monthly heartworm dose eventually stop getting the heartworm preventative altogether, which puts these dogs at risk for life-threatening heartworm disease. It is estimated nearly 27 million dogs are not currently on any heartworm preventative (American Heartworm Society Survey, 2001). While ProHeart 6 is unavailable, we urge dog owners to consult with their veterinarians to discuss alternative preventatives.
Heartworm Disease, which is spread by mosquitoes, is a potentially deadly infection that can cause serious damage to arteries in the heart and lungs eventually leading to heart failure. In severe cases, heartworm disease can damage other organs such as the liver and kidneys. Clinical signs of heartworm disease may not be recognized in the early stages, as heartworms tend to accumulate gradually over a period of months and sometimes years. Heavily infected animals may show clinical signs including mild, persistent cough, reluctance to move or exercise, tiredness after only moderate exercise, reduced appetite and weight loss. Prevention of heartworm disease is the best alternative, as treatment can result in death, severe allergic reactions or pulmonary embolism.
ProHeart 6 is generally well tolerated. Use with caution in sick, debilitated or underweight animals. A small percentage of dogs showed mild, transient swelling or itching at the injection site. While rare, digestive, neurological or hypersensitivity reactions may occur. For prescribing information, see the package insert or call 1-800-477-1365.
Fort Dodge Animal Health, a division of Wyeth , is a leading manufacturer and distributor of prescription and over-the-counter animal health care products for the livestock, companion animal, equine, swine and poultry industries in North America and international markets. Key products include West Nile-Innovator(TM), ProHeart(R) 6, CYDECTIN(R) Pour-On, QUEST(R) Gel and EtoGesic(R) Tablets. The company is headquartered in Overland Park, Kan.
Fort Dodge Animal Health
CONTACT: Kelly Goss of Fort Dodge Animal Health, +1-913-664-7276, orCell - +1-913-206-1687, gossk@fdah.com; or Natalie de Vane, +1-610-999-8756,+1-484-865-5139, devanen@wyeth.com, or Doug Petkus, +1-484-5140,petkusd@wyeth.com
Web site: http://www.wyeth.com/
