Lakeland
Veterinary Hospital
"Caring for pets and the people who love them"
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~ ProHeart 6 is Back ~
In addition to Heartgard for heartworm prevention, we are now also offering ProHeart 6! This is an injectable heartworm preventative that lasts for 6 months! For more information, please follow the below links or contact us at 829-1709.
ProHeart 6 Questions and Answers:
Why was ProHeart 6 voluntarily recalled?
• ProHeart 6 was recalled at the request of the U. S. Food and Drug Administration’s Center for Veterinary Medicine (CVM). We felt it was in the best interest of veterinarians and pet owners to thoroughly address the questions and concerns of the CVM before continuing the marketing of this product. We have always maintained confidence in ProHeart 6 and the unique medical benefits it brings to veterinary medicine.
Why was ProHeart 6 voluntarily recalled?
• ProHeart 6 was recalled at the request of the U. S. Food and Drug Administration’s Center for Veterinary Medicine (CVM). We felt it was in the best interest of veterinarians and pet owners to thoroughly address the questions and concerns of the CVM before continuing the marketing of this product. We have always maintained confidence in ProHeart 6 and the unique medical benefits it brings to veterinary medicine.
How do you respond to the adverse events that have been reported?
• Fort Dodge Animal Health is committed to the safety and efficacy of its products. As a responsible animal health care company and in compliance with federal regulations and established industry protocol, we take any adverse event report very seriously and investigate each case thoroughly.
• It is important to understand Fort Dodge Animal Health reports all adverse events to the CVM unfiltered (meaning all reported potential events are submitted without regard to validity, and cases subsequently determined not to be related to the product are still included in the overall reporting numbers).
• The ProHeart family of products is marketed in major countries (Australia, the Mediterranean regions of Europe and Japan) where heartworm disease is endemic and a serious health risk for dogs. ProHeart has achieved substantial usage in all of these countries, and is the market leader in both Australia and Italy. Each of these countries has a mandatory adverse event reporting system. In each country, the incidence rate for adverse events for ProHeart products is deemed "Very Rare" using World Health Organization (WHO) categories for adverse event reports. Of those events, the majority are allergic in nature, which is consistent with the pattern seen with many pharmaceuticals.
Can you say that ProHeart 6 did not result in any adverse events?
• While we can never rule out an isolated and individual reaction that can occur in an individual dog, investigations have not found any systemic pattern of disease linked to ProHeart 6. We take every report of a dog death seriously and investigate each case thoroughly, whether or not it appears the product in question is involved. We’re pet lovers and owners ourselves. For more than 95 years, Fort Dodge has been dedicated to bringing innovative products to veterinary medicine to protect the health and well being of animals.
• While pharmaceuticals and vaccines are designed to protect a pet from disease, they may also result in an unexpected adverse event. To minimize the risks that exist with any product, it is important to understand the benefits and risks associated with a given product before it is administered. Specific to ProHeart 6, we rely upon veterinarians to evaluate individual pets to determine whether or not the product is the most appropriate heartworm preventative based on a pet’s medical status, lifestyle and other health factors. Our primary objective is to protect a pet’s health and well being.
Was ProHeart 6 ever voluntarily recalled in other countries? Why or why not?
• No. ProHeart was not recalled in any country outside of the United States. Regulatory authorities in each of these countries reviewed the clinical research and reporting in their respective countries, as well as the data from the United States, and decided no recall was necessary.
Did you conduct any new safety or efficacy studies after the product was recalled? If so, what were they?
• Extensive scientific evaluations were conducted during the period the product was in a voluntary recall status. This science-based evidence contributed to the decision to return ProHeart 6 to the U.S. veterinary market. No new efficacy studies were conducted as the product continues to demonstrate proven performance under real-world conditions.