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Canine Autoimmune Hemolytic Anemia (AIHA & IMHA) - I Can't Believe It
| I can't believe this is being aloowed to happen. It was ProHeaert6 that brouht on the AIHA (ad liver damage in Hunter's case) to my Hunter and so many other dogs. It was actually listed on the 2ed warning label change. The FDA had them pull it Sept. 3, 2004, 10 months after my Hunter's death because os so many severe reactions and deaths. For those that don't know, he was a golden retriever who had just turned 4. Now they are allowing them to bring it back. I have read several releases but am only priting the one. They say it has been "reformuylated". I say that means they KNOW it caused all those reactions and deaths during the 3 yeas it was on the market. When it first came out they said it was safe with heartworm positive dogs, in combination with regular vaccinations, antibiotics, young dogs, old dogs, etc. Made it sound as safe as drinking water.,,,until dgs with heartwomrs started dying. The FDA had the change the label to have HW positive dogs treated first. Then as reports came into the FDA they had the maker add warnings about AIHA, seizures, liver problem,s etc. The final warn DEATH was added the day my Hunter got his fatal injection. With the "new formuylad," he label is reading to not give it to dogs with allergies (icluding flea allergy) or sensitivies, not to give within a month of vaccinations, not to give it to sick, underweath, etc, etc dogs. 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(FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish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. I just wanted to warn all of you to NEVER use this product, especially on your AIHA dogs. It could be very fatal. __________________ |
| Sandra Texas |
| Sandra, you should write to the editorial board of the newspaper that published the story. It appears that the only way consumers can spread the word is through advocacy to one another. The lawyers won't touch it. Big pharma has too many political friends and tons of money to make even more money. I am so sorry you have to relive the horrer of your Hunter's needless death. I have the same message with Frontline. Don't use it...ever. It is a pesticde that infiltrates your pet's system. These commercial flea/parasite products are a disgrace regarding the FDA and EPA regulatory 'watchdog' process. |
| jan philly |
This thread was discussed on 06/06/2008
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