Dear Pet Owner:
As you may be aware, on September 3, 2004, Fort Dodge Animal Health announced it is voluntarily complying with the U. S. Food and Drug Administration’s (FDA) request to temporarily cease marketing and recall ProHeart® 6 from the market until the FDA’s questions regarding safety are resolved. To address those concerns, the FDA has promised to convene an independent advisory panel to thoroughly review and evaluate the data. We fully support the initiation of the review process, and will work closely with FDA to provide the necessary information for the panel to make a fair and accurate assessment in a very timely manner.
As a responsible healthcare company, Fort Dodge Animal Health feels it is important to provide you with accurate information about the current situation with ProHeart 6, and to reiterate our confidence in the safety and effectiveness of our product. First and foremost, Fort Dodge Animal Health is committed to providing safe and effective products to ensure the health and well being of pets. Since its launch in 2001, ProHeart 6 has protected millions of dogs against potentially deadly canine heartworm disease.
While Fort Dodge Animal Health is cooperating with the FDA’s request for a recall, we disagree with the Agency’s interpretation of the data and the conclusions that were drawn. Based on a thorough evaluation of the data, and consultation with independent experts in veterinary medicine and epidemiology, Fort Dodge remains confident in the safety and effectiveness of ProHeart 6.
Fort Dodge takes every potential adverse event report seriously and evaluates each case thoroughly. These reports are turned in to the FDA unfiltered, which means all reported potential events are turned in whether or not it is felt the product is involved. Cases later found not to be related to the product remain in the overall reporting numbers and may be used to draw inaccurate conclusions about the product. Overall, the unfiltered reporting rate represents 0.032 percent of the more than 18 million doses sold ” or 3.2 unfiltered reports of allergic reactions and illness per 10,000 doses. Allergic reactions are, unfortunately, seen with many pharmaceutical products.
Extensive safety studies have shown ProHeart 6 is safe for all types of healthy dogs six months of age and older. In field clinical studies, ProHeart 6 was also proven safe when used with other medications commonly used at veterinary hospitals. The ever-increasing number of veterinarians and pet owners that use ProHeart 6 is a strong testimonial to the need, and, indeed, the safety of this product.
If you have questions or concerns about your pet’s healthcare needs, please talk to your veterinarian. For more information about ProHeart 6, visit our website at www.proheart6.com or contact our Professional Services department at 1-800-533-8536. Most importantly, discuss heartworm prevention with your veterinarian to ensure your dog is protected against this potentially deadly disease.
Thank you.
Sincerely,
Michael LaRosh, DVM
Director, Companion Animal
Professional and Technical Services
Fort Dodge Animal Health has voluntarily complied with the U.S. Food and Drug Administration Center for Veterinary Medicine’s request to temporarily cease marketing and recall ProHeart® 6 until the FDA’s questions regarding safety are resolved. While Fort Dodge Animal Health is cooperating with FDA’s request for a recall, we disagree with the Agency’s interpretation of the data and the conclusions that were drawn. Fort Dodge Animal Health strongly supports the FDA’s formation of an independent Advisory Panel to review and evaluate safety data on ProHeart 6, and make a fair and accurate assessment of the information.
2. What should dog owners do if they have used ProHeart 6 for their dog(s)?
Fort Dodge remains confident in the safety and efficacy of ProHeart 6. Pet owners with questions or concerns regarding their pet’s healthcare needs should contact their veterinarian.
3. If ProHeart 6 is not available, what should dog owners’ use?
While ProHeart 6 is unavailable, we urge you to consult with their veterinarians to discuss alternative preventatives. It is important that you protect your dog against this potentially deadly disease.
4. Does Fort Dodge plan to reintroduce the product at a later time?
Fort Dodge Animal Health will make all reasonable efforts to resolve the current concerns and reintroduce ProHeart 6. The Company is committed to working with the FDA to address its concerns and to take the necessary actions to make ProHeart 6 available to veterinarians and dog owners throughout the U.S.
5. If ProHeart 6 has already been voluntarily recalled, why is an independent advisory committee being convened?
While Fort Dodge has agreed to voluntarily recall ProHeart 6 from the market, we continue to be confident in the safety and efficacy of the product. We disagree with the FDA’s interpretation of the data and the conclusions that have been drawn, and feel strongly the data need to be thoroughly reviewed and evaluated by an independent committee of experts from the animal health/veterinary industry. Fort Dodge is pushing for an immediate selection of the committee and review of the data.
6. Was Fort Dodge required to comply with the FDA’s request to voluntarily recall ProHeart 6?
While the announcement indicates this is a voluntary recall, it is important to understand the FDA was going to issue a press release that was very severe in its wording. It was our judgment that this would have put veterinarians in a very undesirable position with their clients. While not a perfect solution, we have chosen to pursue the expert Advisory Panel as the best means of reversing this FDA’s decision.
ProHeart 6 is generally well tolerated. 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 additional information, call 1-800-477-1365.