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Popular Heartworm Medication Recalled

September 3rd, 2004, 11:24 PM
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----- Original Message -----

Popular Heartworm Medicine Recalled
.c The Associated Press

WASHINGTON (AP) - ProHeart 6, a twice-a-year time-released heartworm
medication used to prevent the parasite in millions of dogs, was recalled
Friday at the request of the Food and Drug Administration after thousands
of animals suffered adverse reactions.

ProHeart 6 was the first, and only, product approved by the FDA to be
administered once every six months to treat heartworm 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 ProHeart 6 was used to treat dogs after receiving FDA

As of Aug. 4, the drug agency received 5,552 reports of adverse reactions
after dogs received heartworm shots. About 500 dogs died, though the agency
said many deaths were not directly attributable to the product,
manufactured by Fort Dodge Animal Health, based in Overland Park, Kan., a
subsidiary of the pharmaceutical company Wyeth.

Some dog deaths were linked convincingly to the heartworm medication, which
prompted the recall, said Stephen F. Sundlof, director of the FDA's Center
for Veterinary Medicine.

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 product.

"Despite all of the things that have been done, we continue to see these
adverse events at approximately the same rate," Sundlof told reporters late

The problems suffered by dogs include sudden lethargy, uncontrolled
bleeding, vomiting, diarrhea, heart and liver problems and such nervous
system abnormalities as seizures.

"We don't really understand why this product is causing these problems,"
Sundlof said. "It affects dogs of all sizes and, apparently, dogs of all

Fort Dodge Animal Health is cooperating with FDA's request for a recall but
has "concerns about how the agency interpreted these complex data," the
animal health product manufacturer said in a prepared statement. "Based on
a thorough evaluation of FDA's data and consultation with independent
experts in veterinary medicine and epidemiology, Fort Dodge Animal Health
stands behind ProHeart 6."

The FDA will convene an independent scientific advisory committee to review
the matter.

Heartworm disease is caused by a parasite transmitted to dogs via mosquito
bite. Roughly 250,000 dogs develop the potentially fatal ailment per year.
Fort Dodge Animal Health said it has sold 18 million doses of ProHeart 6 to
veterinarians since FDA approval in June 2001.

On the Net:
Fort Dodge Animal Health:
09/03/04 18:45 EDT

Copyright 2004 The Associated Press.

September 3rd, 2004, 11:31 PM
Here's a better link:

September 4th, 2004, 12:11 AM
I'm glad our clinic has never used it!

Lucky Rescue
September 4th, 2004, 09:50 AM
I wonder how many dogs had to die for this medication to be recalled. :mad:

September 4th, 2004, 06:23 PM
This was going to be recalled some time ago, not just now. I know that because when we my Vet and I where talking to Dr.Fisher from Pfizer Animal Health about what meds was best for Blaze's mange Dr.Fisher told us about that only because Blaze was on heartworms meds twice monthly at this time and we talked about all the meds for heartworm out now and the danger of it. I never said anything because I thought it was nolonger being sold and everyone who was using it was be called or sent a letter.