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The Senior Dogs Project "Blessed is the person who has earned the love of an old dog." |
The Senior Dogs Project "Blessed is the person who has earned the love of an old dog."
..........."Looking Out for Older Dogs" ...........
- Sydney Jeanne Seward
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ProHeart6 -- September 4, 2004 -- ProHeart6 Withdrawn from Market From a news release appearing on the FDA website: Fort Dodge to Comply with FDA's Request to Recall ProHeart 6 Injectable Heartworm Product from the Market Due to Serious Health Concerns Fort Dodge Animal Health, of Overland Park, Kansas, at FDA's request, has agreed to immediately cease production and recall its heartworm medication ProHeart®6 from the market until the FDA's concerns about adverse reaction reports associated with the product can be resolved. FDA is requesting that the firm continue to conduct research to determine the cause of related adverse reactions and develop a strategy to help prevent such problems in the future before the product is marketed again. The FDA will convene an independent scientific advisory committee to thoroughly evaluate all available data. Read more...... Reports of Side Effects We first began receiving reports of side effects of ProHeart6 in the fall of 2002, as follows: "My name is Janice Storey. My dog, too, became ill because of the ProHeart6 shot and died on October 17. Along with Myra Kirkland, I am on a mission to save other dogs and make it mandatory that veterinarians present the ProHeart6 label for review prior to a consumer making a decision about this shot. My dog, Trouble, received his annual vaccinations along with the ProHeart6 shot. He began coughing shortly thereafter and was dead within weeks." jstorey1@swbell.net Since that time, a site has been created that posts reports of adverse side effects to the ProHeart6 shot. It is updated regularly and can be reached via this link: ProHeartInformation. History of ProHeart6 ProHeart6 (made by Fort Dodge Animal Health) was introduced to the market in 2001. It is an injectable form of heartworm medication that a veterinarian administers every six months to protect a dog from heartworm infection. A description of heartworm disease and the way in which ProHeart6 works can be found on the Fort Dodge website. Although trials of the medication indicated it conformed to the government's safety standards, it was only after the drug had been used more widely and over a longer period of time that adverse side effects, including death, began to appear in increasing numbers. Dr. Victoria Hampshire, adverse drug events coordinator for the FDA, on November 1, 2003 made the following comments: "By law, drug manufacturers must report all adverse reactions brought to their attention to the FDA. When this drug was initially marketed, it was believed to be safe for heartworm positive dogs; then we found that dogs were dying that were heartworm positive." At the end of August 2003, Fort Dodge distributed a "Dear Doctor" letter to veterinarians with updated information about the drug. Although stating that the number was low, Fort Dodge notes, "Death has been reported in approximately .0025 percent of the doses sold into veterinary clinics." It is interesting to note that, even during clinical trials, three dogs died when given the shot. Two deaths were attributed to the dogs' "being older" and the third to the dog's being "underweight." The letter to veterinarians from Fort Dodge advised that the following was being added to the label information for ProHeart6: "Cardiopulmonary signs such as coughing and dyspnea may occur in heartworm-positive dogs treated with ProHeart6." And, under the "Precautions," the following change was made: Removal of the statement, "At the discretion of the veterinarian" before the sentence, "Infected dogs should be treated to remove adult heartworms." It is extremely important, if you suspect your dog has had an adverse reaction to ProHeart6, that you report both to Fort Dodge Animal Health and to the FDA. The toll-free number for Fort Dodge is: 1.800.533-8536 . You can file a report with the FDA by telephone at: 1-888-332-8387 (or 1-888-FDA-VETS) or: You may also report an adverse drug experience using a form that is available on the FDA website. Access to the form is at http://www.fda.gov/cvm/index/ade/adetoc.htm Just print out the form, complete it and mail it. It is two-sided and postpaid. If you you would like to be in touch with others whose dogs have experienced a negative reaction to ProHeart6, here are the people to contact:
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