Free Republic
Browse · Search
News/Activism
Topics · Post Article

Skip to comments.

Dog Medicine Is Recalled at Request of F.D.A.
NY Times ^ | September 5, 2004 | NA

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.


TOPICS: Business/Economy; Extended News; Government; News/Current Events; US: District of Columbia
KEYWORDS: animals; dogs; fda; health; medicine; moxidectin; proheart6
Navigation: use the links below to view more comments.
first previous 1-2021-4041-46 last
To: Salamander
A call to your veterinarian is warranted to find out about the lots that were recalled. Your veterinarian was "pushing" Proheart in all good conscience, veterinarians don't like to create problems. If he/she is like me, we try to make the care of the animals as efficient and easy as one can. Unfortunately, I am guessing that 90% of the reactions that are listed can be traced to other predisposing causes and because expenditures to diagnose a problem is expensive, the easy route is to blame the drug. I also know that PETA has been after American Home Products/Ft. Dodge since the Premarin episode and a lot of data that is out there is unsubstantiated biased accusation by the PETA folks trying to hurt American Home Products (Quest is one drug for one that got hit by PETA hard). Delayed reactions are rare, if your dog had had a reaction to the Proheart it would have been in the first weeks after the injection according to all I have read and personally observed. I hope this helps some, I know I am going to get bombarded tomorrow at work for the same reason but I have been prepared and knowledgeable about this drug for quite some time.
41 posted on 09/06/2004 9:27:09 AM PDT by vetvetdoug (In memory of T/Sgt. Secundino "Dean" Baldonado, Jarales, NM-KIA Bien Hoa AFB, RVN 1965)
[ Post Reply | Private Reply | To 40 | View Replies]

To: Ole Okie

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.


42 posted on 09/06/2004 9:35:33 AM PDT by vetvetdoug (In memory of T/Sgt. Secundino "Dean" Baldonado, Jarales, NM-KIA Bien Hoa AFB, RVN 1965)
[ Post Reply | Private Reply | To 7 | View Replies]

To: vetvetdoug

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?]





43 posted on 09/06/2004 10:16:02 AM PDT by Salamander
[ Post Reply | Private Reply | To 41 | View Replies]

To: vetvetdoug

Thanks for your reply. No more heartworm shots for Buddy.

I learn a lot on Free Republic.


44 posted on 09/06/2004 11:23:54 AM PDT by Ole Okie
[ Post Reply | Private Reply | To 42 | View Replies]

To: Salamander

FReepmail on the way......


45 posted on 09/06/2004 7:22:06 PM PDT by Chong (God Bless and Protect our Troops.)
[ Post Reply | Private Reply | To 38 | View Replies]

To: Ole Okie

So do I.
I never would have heard about this without FR.

[I LOVE this place!]...:)


46 posted on 09/06/2004 7:46:45 PM PDT by Salamander (This Is A Dark Ride)
[ Post Reply | Private Reply | To 44 | View Replies]


Navigation: use the links below to view more comments.
first previous 1-2021-4041-46 last

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.

Free Republic
Browse · Search
News/Activism
Topics · Post Article

FreeRepublic, LLC, PO BOX 9771, FRESNO, CA 93794
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson