Burpdog Posted June 10, 2008 Share Posted June 10, 2008 Oi vey. I personally would never give this to a greyhound. Bold added: FDA Release FDA News FOR IMMEDIATE RELEASE June 5, 2008 Media Inquiries: Kimberly Rawlings and Mike Herndon, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Announces Limited Return of Heartworm Drug to U.S. Market The U.S. Food and Drug Administration (FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death. ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, manufactured by Fort Dodge Animal Health, Overland Park, Kan., is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. "This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs," said Bernadette Dunham, D.V.M., Ph.D., director, FDA’s Center for Veterinary Medicine. "While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions." Heartworm disease is a serious and potentially fatal condition for dogs. The parasite that causes heartworm disease is transmitted through the bite of a mosquito. The risk minimization and restricted distribution program is intended to educate veterinarians and pet owners regarding the possible risks associated with the use of ProHeart 6. Therefore, Fort Dodge Animal Health is requiring veterinarians who wish to purchase ProHeart 6 to register with the company and participate in a Web-based training program prior to obtaining the product. The return of ProHeart 6 to the market is based on results of additional toxicological and pharmacologic studies by Fort Dodge Animal Health coupled with the low adverse reaction frequency in international markets. In 2004, Fort Dodge Animal Health agreed to voluntarily recall the product from the market based upon FDA's concerns regarding reports of serious adverse reactions in dogs following the use of ProHeart 6. In response to FDA's concerns, the manufacturer conducted additional testing of its product, which indicated that residues of the solvents used in the manufacture of ProHeart 6 may cause allergic reactions. The manufacturer has improved the manufacturing specifications for ProHeart 6 to decrease the presence of those residues and has marketed the product in international markets. Few adverse events have been reported with this reformulated product. The ProHeart 6 label and Client Information Sheet have been revised to include updated safety information. The new label includes warnings not to administer the drug within one month of vaccinations, and to use the product with caution in dogs with pre-existing allergic diseases including food allergies, allergic hypersensitivity, and flea allergy dermatitis. The label also warns against administering the drug to dogs who are sick, debilitated, underweight, or who have a history of weight loss. In addition, the label’s Post-Approval Experience section has been updated to include information about adverse reactions based on voluntary post-approval drug experience reporting. Dog owners who suspect their dog is experiencing an adverse reaction to ProHeart 6 should immediately contact their veterinarian to initiate appropriate veterinary care. Veterinarians should contact Fort Dodge Animal Health to report any adverse events at (800) 533-8536. # Quote Diane & The Senior Gang Burpdog Biscuits Link to comment Share on other sites More sharing options...
Guest KennelMom Posted June 10, 2008 Share Posted June 10, 2008 Proheart 6 thread We won't use it either. It weirds me out on a lot of levels and I just don't find it difficult to heartworm my dogs every 30 days. Quote Link to comment Share on other sites More sharing options...
Guest Ola Posted June 10, 2008 Share Posted June 10, 2008 Honestly, I wouldn't give it to any dog. At the very least I'd wait a few years to see what other reactions they come up with - I never like my dogs to be the guinea pigs. And those warnings they list - yikes! I doubt they'll be followed very closely either, especially since the consumer most likely doesn't get to see the labels. Quote Link to comment Share on other sites More sharing options...
gazehund Posted June 10, 2008 Share Posted June 10, 2008 I'll pass too. Quote Link to comment Share on other sites More sharing options...
NeylasMom Posted June 10, 2008 Share Posted June 10, 2008 The risk minimization and restricted distribution program is intended to educate veterinarians and pet owners regarding the possible risks associated with the use of ProHeart 6. Therefore, Fort Dodge Animal Health is requiring veterinarians who wish to purchase ProHeart 6 to register with the company and participate in a Web-based training program prior to obtaining the product. If this course is anything like the courses I have to take for my job on internet safety and privacy concerns (I work in health research) then it's totally useless unless the vet really cares to pay attention. Page...page...page...print certificate...done. Quote Jen, CPDT-KA with Zuri, lab in a greyhound suit, Violet, formerly known as Faith, Skye, the permanent puppy, Cisco, resident cat, and my baby girl Neyla, forever in my heart "The great thing about science is that you're free to disagree with it, but you'll be wrong." Link to comment Share on other sites More sharing options...
Guest LynnM Posted June 10, 2008 Share Posted June 10, 2008 I've said it before and I'll say it again. People that post on internet message boards are the creme de la creme of dog owners. The other 99.9 percent of dogs are not so lucky. This product has a much greater chance of saving their life than it does of ending it. PH6 is not the best option for those that are capable of remembering to give a monthly preventative. I think everyone can agree on that. If you spend a week working in a vet's office and observe what the "norm" is among pet owners, you'll see why a medication like ProHeart 6 is so important to the health of a lot of dogs. Lynn Quote Link to comment Share on other sites More sharing options...
Guest greybookends Posted June 10, 2008 Share Posted June 10, 2008 I used it before it was taken off the market without any problems and have been anxiously waiting for it to come back. Quote Link to comment Share on other sites More sharing options...
Guest LynnM Posted June 10, 2008 Share Posted June 10, 2008 I used it, too, as it was free for employees of the clinic where I was working. It worked fine and no ill effects. I'm not sure I'd use it now, not because of any safety concerns, but rather, because it doesn't have a great track record against intestinal parasites. There's no point in using it when I still have to dose with ivermectin on a regular basis. Lynn Quote Link to comment Share on other sites More sharing options...
Burpdog Posted June 24, 2008 Author Share Posted June 24, 2008 I used it before it was taken off the market without any problems and have been anxiously waiting for it to come back. Makes me sad It only takes once. When you do this shot, you cannot take it back..... Quote Diane & The Senior Gang Burpdog Biscuits Link to comment Share on other sites More sharing options...
Guest Peanut Posted June 24, 2008 Share Posted June 24, 2008 I used it before it was taken off the market without any problems and have been anxiously waiting for it to come back. Ditto here! I used it before it was taken off the market without any problems and have been anxiously waiting for it to come back. Makes me sad It only takes once. When you do this shot, you cannot take it back..... But, regardless of what you give them -- interceptor, heart guard, etc. -- you can't take it back. I've seen horrible reactions from some of them, too. Quote Link to comment Share on other sites More sharing options...
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