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Re: [RC] FDA Warning Letter to Fort Dodge - heidiFort Dodge Animal Health Warning Letter http://www.fda.gov/foi/warning_letters/g4602d.htm Many of you know that my horse lost his vision in his right eye and has very limited vision in his left. I have never really told you what caused the blindness, after reading this link, I feel I must tell you. On March 27, 2003, my horse had an adverse reaction to the Fort Dodge IN Strangle vaccine, the adverse reaction caused the loss of vision. A few months later a woman in my area lost her stallion to an adverse reaction to the Fort Dodge IN Strangles vaccine. Both of us use the same Vet, both horses were vaccinated by the same Vet, both horses received the Fort Dodge IN Strangles from the SAME VACCINE BATCH AND THE SAME VACCINE VIAL. I sit here in tears....wondering if what happen to my beloved horse could have been prevented....IF FORT DODGE... had followed the law. First of all, I feel for you with the problems you and your horse have suffered. However, I can't draw the same conclusions with regard to a boycott of Fort Dodge based on what you have related. One, the FDA warning letter that you referenced is typical of letters that FDA sends regularly to all sorts of companies. The fact that it is a warning letter is indicative that FDA didn't find anything very egregious in the inspection--if they had, they would have shut FD down then and there. The inspections that they do are routine inspections designe to ferret out minute details such as what they did, and to advise companies of those infractions and inadequacies so that the companies can tighten up procedures and keep processing techniques safe. Two, the issues addressed in the FDA letter are not the same issues that cause adverse vaccine reactions. Fort Dodge uses a different adjuvant (the carrier in the vaccine that helps the animal build an immune response) than most other companies do. This adjuvant is highly effective in stimulating the animal to form an immune response. The trade-off is that it is also more apt to cause undue soreness or swelling in some individuals. This is pretty common knowledge in the veterinary profession, and many of us do not feel that the trade-off is worth it. Hence we rarely use Fort Dodge vaccines. Others feel that the trade-off IS worth it, and continue to do so. (This is not the same sort of reaction as anaphylaxis--the anaphylaxis rate for vaccines is about one in 30,000 regardless of what type of vaccine you use, and is one of the risks of vaccinating at all--one always has to weigh the risk of vaccinating against the risk of getting the disease, and the latter is usually worse.) With regard to abcesses following use of the IN strangles vaccine--this is almost ALWAYS due to either improper administration or to the horse having a pre-existing open lesion of some sort. There are significant warnings about how to handle this vaccine, and yet I continue to be amazed at how often those warnings are not heeded. The IN vaccine is a live bacterial vaccine--you are literally putting bacteria up the horse's nose to stimulate an immune response. The bacteria is altered so that it does not cause actual strangles. But if the bacteria enters a wound or is carried into the body by a subsequent injection of something else, the sorts of abcesses you describe can and do occur. Last I checked, this was fully discussed on the label, and it is up to the person administering the vaccine to do it right. All vaccines have different rates of adverse reactions, and at NO time should one consider vaccination to be a completely innocuous process. Animal owners SHOULD educate themselves about the risks of adverse reactions and should decide whether the risk of disease outweighs the risk of reaction for each and every vaccine given. That said--none of this applies to other Fort Dodge products. FD is not my favorite company, but I am disturbed that people would boycott their entire product line because of a vaccine reaction. I do personally avoid their vaccines due to the already-mentioned issues with the adjuvants--with the exception of the IN strangles (when appropriate) simply because at this point it is the best thing on the market for preventing strangles. (Do I vaccinate my herd with it? No. But then I don't put my herd at risk for strangles. I would not hesitate to use it on specific individuals who might run the risk of exposure, and I HAVE used it in the face of serious strangles epidemics with good success. If you have ever had to nurse multiple herds of horses through a serious strangles outbreak, you would likely agree that in the face of THAT risk, the risk of the vaccine is well worth it.) I will continue to use those Fort Dodge products that I deem appropriate in my horses, even though I choose not to use their vaccines for the above-stated reasons. And I am always disappointed to see an entire company damned because an animal suffers from risks that that have been openly disclosed. Again, I'm sorry for your tragic outcome with your horse, but I am also sorry to see you draw the sorts of conclusions you have drawn, and I do not feel those conclusions are supported by the evidence you have cited. Heidi ============================================================ REAL endurance is taking your non-horsey family to a ridecamp with you! ~ Heidi Sowards ridecamp.net information: http://www.endurance.net/ridecamp/ ============================================================
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