proheart6 recalled (it's about time)
Popular Heartworm Medicine Recalled
By DIEDTRA HENDERSON
.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 approval.
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 Friday.
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 ages.''
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.
Please read the "fine print"!
Although this "recall" of ProHeart6 may seem like good news to
the thousands of dog owners who have had an "adverse reaction"
to the drug...
A CLOSE READING of both the FDA and Fort Dodge Announcements
gives reason for concern -
This "recall" *MAY* not be all that "permanent"!
Here's the lead paragraphs taken from the Fort Dodge web site...
EMPHASIS ADDED by me >>>
FORT DODGE ANIMAL HEALTH TO
VOLUNTARILY RECALL PROHEART®6
Company Supports Independent Scientific Panel to Review Complex Data
OVERLAND PARK, Kan. (September 3, 2004) -
Fort Dodge Animal Health, a division of Wyeth (NYSE: WYE),
announced today that it will voluntarily comply with the U.S. Food and Drug Administration Center for Veterinary Medicine's request to temporarily cease production and recall ProHeart® 6, a heartworm preventative, from the market until the FDA's questions regarding safety are resolved. Fort Dodge Animal Health also announced its support for FDA's formation of an independent Advisory Panel to review safety data on ProHeart® 6. The panel will review safety data based on reports submitted through FDA's voluntary self-reporting system.
While Fort Dodge Animal Health is cooperating with FDA's request for a recall, we have concerns about how the agency interpreted these complex data. As such, the Company fully supports the initiation of this review process, and will work closely with FDA to provide any necessary information for the panel to make a fair and accurate assessment of these data. We look forward to working with the panel and remain confident in the safety and efficacy of ProHeart® 6. ..."
Then they go on to write what amounts to a Glowing Advertisement
for the stuff! :mad:
Sadly :( ~
"temporarily cease production" does NOT mean they intend
to stop ever making the stuff!!
Bottom line is Fort Dodge is NOT convinced they make a
bad, dangerous, or flawed product.
And they are going to do their darndest to get the FDA to
allow them to RE-introduce the product.
Fort Dodge is looking at this much like a baseball crowd looks at rain ~
just a lil "temporary rain delay of the game"...
:( :mad:
Here's the Fort Dodge "Announcement" page >>>
Fort Dodge ProHeart6 News Release
/s/ :( Phred
..
