sandra_slayton
Posted : 4/10/2006 11:19:58 AM
I was n ot at the FDA/CVA "hearing", but know several there were. Both sides presented their evidence. Fort dodge was there in force. But even after both sides were heard, it was decided that PH6 had not been proven safe enough and the panel wanted Fort Dodge to do more studies and prove it was as safe as they had said. One of the panel who voted that it could be returned said a black box warning should be added. I understand that has never been done on an animal med. Note I said I understand, but I can not state that as fact.
Also Canada gave Fort Dodge a certain lenght of time to prove it was as safe as they said, and apparently from the "recommended" label change, Fort dodge did not prove it. I also agree with someone else's post. Many times recommend or request is a nice way of saying do it. Like when i woud say to my boys "Please clean up your room." I may ask please do it , but they knew I MEANT do it.
There were a few whose dogs never left the hospital after getting PH6 shots--went in seizure or shock and couldn't be brought out. Fort dodge said it couldn't be the PH6 because it happaned to soon. Others went into seizures or got sick 9-10 laters, and Fort dodge said it couldn't be PH6 because it would have happened sooner. They told ones who did not have a necropsy done that it couldn't be proven it was PH6 because there was no necropsy done. And then they told ones like me who DID have necropsy done that there was no scientific evidence that PH6 killed my dog. I asked for scientific evidence that it DID NOT kill him, but they couldn't provide it. I know of one dog, a border collie mix, age 7 1/2 who went into a seizure, his first ever, 10 hours after getting his 4th proheart6 injection. The only way to stop it was to totally knock him out. But as soon as he started coming out of it, the seizure started up again. Thirty six hours after his 4th PH6 injection, he was dead. Bandit died in Wisconsin the same day my Hunter died here. Fort Dodge denies Proheart6 killed Bandit even tho that was the only thing he got that and he had never had a seizure in his 7 1/2 years.
I sure didn't know they were doing studies on ProHeart6 over in Europe, etc. Never saw anything about them, and they were not mentioned at the FDA/CVA panel hearing. If they were proving that PH6 was so safe, why didn't Fort Dodge bring in the study reports? I believe they only talked about the 12 month version in Austalia---where THEY rule on reactions and deaths, and we know what they say here. Here if the dog doesn't have the reaction start at exactly 6 days 12 hours, 49 minutes after the injection, it isn't Proheart6 that caused it. I know that is rather a snide remark, but when everyone I have talked to via e-mail or phone were told it was not Proheart6 that caused their dog/dogs' reaction and or death because it happened to soon, it happend not soon enough, this, that and younder. that snide remark is

retty much is true. I am going to post a picture of my Hunter, my beautiful, precious boy who died of AIHA after his 3rd PH6 injection and there is not a trace of doubt in my mind it was the PH^ that caused his death.