Dear Concerned Dog Owner:

As you may be aware, on Friday, September 3, 2004 The U.S. Food and Drug Administration requested a voluntary recall of ProHeart 6, the injectable six-month heartworm preventative for dogs.

In the past few days, there has been extensive media coverage of the recall. Unfortunately some of the information has been unclear and inaccurate, which has created confusion and concern among many pet owners. Please be assured that we have used ProHeart 6 because extensive studies have shown it safe and effective against potentially deadly heartworm disease for all types of healthy dogs 6 months of age and older. In our clinic, Dr. Owens has administered it to his dog and Dr. Johnson has used it for her mother’s dogs. We have not had any serious reactions from the many doses we have administered to our patients. For many pet owners compliance is the number one reason for using ProHeart 6. Forgetting to give a monthly heartworm preventative on time or at all puts your dog at significant risk for potentially deadly heartworm disease.

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 causes, and cases that are determined not to be related to the product remain in the overall reporting numbers. In most media stories, the issue of “unfiltered” is never addressed. The overall report numbers are presented as fact-as if all reports are equal to adverse reactions that have definitively been linked to ProHeart 6.This is simply not the case. ProHeart 6 is generally well tolerated. A small percentage of dogs showed mild, transient swelling or itching at the injection site. While rare, digestive, and neurological or hypersensitivity reactions may occur. To put this in perspective, of the 18 million doses sold, there have been approximately 3.5 reported “unfiltered” reactions of some kind per 10,000 doses.

While Fort Dodge Animal Health, a division of Wyeth, remains confident in the safety and effectiveness of ProHeart 6, the company is cooperating with the FDA’s request to cease marketing and voluntarily recall ProHeart 6 from the veterinary market until the FDA’s concerns are resolved. Fort Dodge will work with an independent advisory committee to assure a thorough review and evaluation of product information. We will advise you of the findings of this committee, or and other information related to ProHeart 6, as it becomes available. Since its launch in 2001, ProHeart 6 has protected millions of dogs against heartworm disease. The product used in Australia “ProHeart SR-12” has not been removed from the marketplace.

It is very important to make sure your dog is protected against heartworm disease. We have a variety of monthly heartworm preventatives either oral or topical, that we will prescribe for your pet, depending on individual needs and preferences, when the next ProHeart 6 injection is due.

If you have questions or concerns about your pet’s healthcare needs, please call our office at 748-4400. For more information about ProHeart 6, you may visit www.proheart6.com or our website, www.riverbrookpetvet.com. If you think your pet has had a reaction to ProHeart 6 contact the manufacturer’s professional Services Department at 1-800-533-85356.

Thank you for your attention to this important Information.

Sincerely, Robin L. Johnson D.V.M.

 © Robin Johnson, D.V.M. 2001-2008. All rights reserved.