04-22-2004, 09:09 PM
The Food and Drug Administration approved the drug in 2001 as safe and effective for the prevention of heartworm disease.
Now FDA officials say they’re concerned about the unexpected number of adverse reactions that have been reported by veterinarians and petowners whose dogs were given the drug, and an investigation is underway.
Now some of those dog owners are telling their story for your pet's sake.
Cletius, Vito and Murphy. Three families' beloved pets that suddenly got very sick.
"I was horrified. I had no idea what was going on at the time," dog owner Georgene Paulauski said.
She is talking about what she thinks is Cletius's reaction to ProHeart 6. It is the first and only injectible form of medicine that prevents heartworm disease for six months.
“I feel so guilty about this because I did it for convenience sake of not having to give a monthly pill," Paulauski said.
She's one of more than 4 thousand who've made reports to the FDA about adverse reactions they believe their dogs suffered from ProHeart 6. More than 400 of those dogs died or were put to sleep by their owners.
Dr. Bob Rogers, an outspoken critic from Texas, is one of several veterinarians we talked to who say they won't give the shot.
"I think that's a very alarming number," Veterinarian Dr. Bob Rogers said.
He prefers monthly oral medications that have been on the market for more than a decade.
The reactions to ProHeart 6 reported to the FDA include: severe allergic reactions, vomiting, diarrhea, convulsions, weight loss and an auto immune anemia.
Paulauski of Crown Point Indiana filed an adverse reaction report after 5-year-old Cletius got sick a few weeks after his injection.
Cletius was diagnosed with an autoimmune disease in which the body destroys its own red blood sells.
"He's been poked and prodded and to surgery and back and multiple units of blood multiple transfusions," Paulauski said.
The steroids to help Cletius recover caused additional complications.
"They found a massive bleed, a huge huge huge bleed in his belly," Paulauski said.
Another report was filed by this Kankakee couple after their 9-year-old Yorkie became incontinent.
"She wouldn't drink, she wouldn't eat, she started losing her physical strength," said Jim Rentas, the dog’s owner.
"And you know what the consequences are of that and your desperation at trying to get this in her is overwhelming," Laurie Rentas said.
Overwhelming for an Oak Forest couple who own 10-month-old Vito. They say that an hour after his shot. Vito couldn't get up. That night he had a seizure.
“He was foaming at the mouth, he had lost control of his bladder and he was seizing so bad I thought he broke he back," Vito’s owner, Kim Russ said.
"Within two days you know he was a, he was like a vegetable," Tim Russ said.
After two anguishing months of treatments the Russ' put Vito to sleep.
The FDA has been checking a number of possibilities from whether there are any impurities in the manufacturing process, to whether the proper dosages are being given. So far nothing abnormal has turned up, but the reviews are continuing.
Fort Dodge Animal Health, the manufacture of ProHeart 6, says its review of the cases show that "no definitive links could be made to the drug.” The company says millions of dogs like cooper have been protected without any problems.
In a written response to our questions, the company said the adverse reactions reported amount to less than one percent of the 15 million doses sold.
The company said most cases that require medical treatment respond quickly to medical intervention.
But since ProHeart 6 is a time-released drug that stays in a dog's system for six months, vets say it can take that long for a dog to recover.
“He's not out of the woods yet. They still aren't promising us anything. If he'll live," Paulauski said.
In the last two years the FDA has required changes to the label for ProHeart6 warning about the possibility of severe allergic reactions and in rare cases death.
FDA officials say there is no pattern to the reported problems when it comes to the size, breed or age of the dogs.
Experts say none of this should deter pet owners from giving their dogs heartworm medication. You should consult with your veterinarian on all the available choices.
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Now FDA officials say they’re concerned about the unexpected number of adverse reactions that have been reported by veterinarians and petowners whose dogs were given the drug, and an investigation is underway.
Now some of those dog owners are telling their story for your pet's sake.
Cletius, Vito and Murphy. Three families' beloved pets that suddenly got very sick.
"I was horrified. I had no idea what was going on at the time," dog owner Georgene Paulauski said.
She is talking about what she thinks is Cletius's reaction to ProHeart 6. It is the first and only injectible form of medicine that prevents heartworm disease for six months.
“I feel so guilty about this because I did it for convenience sake of not having to give a monthly pill," Paulauski said.
She's one of more than 4 thousand who've made reports to the FDA about adverse reactions they believe their dogs suffered from ProHeart 6. More than 400 of those dogs died or were put to sleep by their owners.
Dr. Bob Rogers, an outspoken critic from Texas, is one of several veterinarians we talked to who say they won't give the shot.
"I think that's a very alarming number," Veterinarian Dr. Bob Rogers said.
He prefers monthly oral medications that have been on the market for more than a decade.
The reactions to ProHeart 6 reported to the FDA include: severe allergic reactions, vomiting, diarrhea, convulsions, weight loss and an auto immune anemia.
Paulauski of Crown Point Indiana filed an adverse reaction report after 5-year-old Cletius got sick a few weeks after his injection.
Cletius was diagnosed with an autoimmune disease in which the body destroys its own red blood sells.
"He's been poked and prodded and to surgery and back and multiple units of blood multiple transfusions," Paulauski said.
The steroids to help Cletius recover caused additional complications.
"They found a massive bleed, a huge huge huge bleed in his belly," Paulauski said.
Another report was filed by this Kankakee couple after their 9-year-old Yorkie became incontinent.
"She wouldn't drink, she wouldn't eat, she started losing her physical strength," said Jim Rentas, the dog’s owner.
"And you know what the consequences are of that and your desperation at trying to get this in her is overwhelming," Laurie Rentas said.
Overwhelming for an Oak Forest couple who own 10-month-old Vito. They say that an hour after his shot. Vito couldn't get up. That night he had a seizure.
“He was foaming at the mouth, he had lost control of his bladder and he was seizing so bad I thought he broke he back," Vito’s owner, Kim Russ said.
"Within two days you know he was a, he was like a vegetable," Tim Russ said.
After two anguishing months of treatments the Russ' put Vito to sleep.
The FDA has been checking a number of possibilities from whether there are any impurities in the manufacturing process, to whether the proper dosages are being given. So far nothing abnormal has turned up, but the reviews are continuing.
Fort Dodge Animal Health, the manufacture of ProHeart 6, says its review of the cases show that "no definitive links could be made to the drug.” The company says millions of dogs like cooper have been protected without any problems.
In a written response to our questions, the company said the adverse reactions reported amount to less than one percent of the 15 million doses sold.
The company said most cases that require medical treatment respond quickly to medical intervention.
But since ProHeart 6 is a time-released drug that stays in a dog's system for six months, vets say it can take that long for a dog to recover.
“He's not out of the woods yet. They still aren't promising us anything. If he'll live," Paulauski said.
In the last two years the FDA has required changes to the label for ProHeart6 warning about the possibility of severe allergic reactions and in rare cases death.
FDA officials say there is no pattern to the reported problems when it comes to the size, breed or age of the dogs.
Experts say none of this should deter pet owners from giving their dogs heartworm medication. You should consult with your veterinarian on all the available choices.
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