Posted on 09/05/2004 6:24:33 PM PDT by neverdem
By THE ASSOCIATED PRESS
WASHINGTON, Sept. 4 (AP) - A time-released medication used to prevent heartworm in millions of dogs was recalled Friday at the request of the Food and Drug Administration after thousands of dogs suffered adverse reactions.
The medication, ProHeart 6, is the only product approved by the agency to be administered twice a year to treat the disease in dogs. Its active ingredient, moxidectin, has been administered without problem to horses and cattle.
The time-released version caused few problems when given to dogs at higher doses in clinical trials. Health and safety problems quickly cropped up, however, when it was used to treat dogs after receiving federal approval.
As of Aug. 4, the Food and Drug Administration had received 5,552 reports of adverse reactions after dogs received heartworm shots. About 500 dogs died. The agency said many of those deaths were not directly attributable to the medication, but Stephen F. Sundlof, director of the agency's Center for Veterinary Medicine, said some deaths were linked to it convincingly, which prompted the recall.
ProHeart 6 is manufactured by Fort Dodge Animal Health, based in Overland Park, Kan., a subsidiary of the pharmaceutical company Wyeth.
Fort Dodge is cooperating with the agency's request for a recall but has "concerns about how the agency interpreted these complex data," the company said in a prepared statement. "Based on a thorough evaluation of F.D.A.'s data and consultation with independent experts in veterinary medicine and epidemiology, Fort Dodge Animal Health stands behind ProHeart 6."
Dog owners were urged to consult veterinarians about other medications to prevent heartworm.
The agency had already asked Fort Dodge to revise the drug's label and to issue notices to veterinarians and dog owners pointing out safety questions associated with the drug.
The problems suffered by dogs include sudden lethargy, uncontrolled bleeding, vomiting, diarrhea, heart and liver problems and seizures.
"We don't really understand why this product is causing these problems," Mr. Sundlof said.
FWIW, I own a Jack Russel that had a reaction to Proheart that was transient. I gave her a steroid and then after six months we went back to heartgard. My personal experience with Proheart made me advise against using Proheart with Jack Russels, Pugs, Boston Terriers and Chihuahuas.I think Proheart is excellent in large breed dogs that are not over 8 years old or debilitated with preexisting disease. Proheart will take some tinkering to make it safer for dogs but after working with the Fort Dodge veterinarians in research and professional support, many of the adverse reactions to moxidectin were new and totally unexpected and after studies on the efficiency of the drug was thoroughly studied.
I really appreciate you taking the time to explain all this and I feel somewhat better knwoing that *if* something was going to happen, if probably already would have.
Peace of mind, regarding my "kids" is priceless.
I'll call tomorrow when his office reopens and ask for the lot information.
Otherwise, this vet is a great guy who is very gentle and understanding of the "special personalities" of Ibizans.
For example, he is the -only- vet whom my older Ibizan bitch does *not* try to bite.
[they are a very "offish/one person" breed and just have this "thing" about people messing with them if it's not their "mom" or "dad"]...;)
Good luck to you tomorrow.
It sounds like you'll be needing it.
[does anyone really listen to what PETA crackpots say anymore?]
Thanks for your reply. No more heartworm shots for Buddy.
I learn a lot on Free Republic.
FReepmail on the way......
So do I.
I never would have heard about this without FR.
[I LOVE this place!]...:)
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