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Animals In Print
The On-Line Newsletter

31 May 2004 Issue

Proheart 6 Allegedly Dangerous To Dogs

An NBC investigation in Dallas is reporting an alarming number of cases of sickness and deaths being attributed to the use of the new six month heartworm preventative Proheart 6.  Those who use Proheart 6 on their own dogs should take heed to these warnings until solid proof can be resented that these shots are safe for your canine friends.

Fort Dodge, who manufactures the Proheart 6 injection has a huge investment in it's market success and clings to the company's position that the drug is safe.  But the evidence of the number of deaths due to the use of Proheart 6 is alarming.  With proven heartworm medications, like Heartgard and sentinel, which have a much lower adverse reaction and death rate, one should question the logic in experimenting with this new medication on your own pets.

Proheart 6 is a sponsor to the upcoming Conference Homeless Animal Management and Policy seminar scheduled in Orlando, FL in mid-August.

Heartworm Medicine Linked To Sickness, Death FDA Receives More Than 5,000 Adverse Reaction Reports
POSTED: 3:21 pm CDT May 25, 2004
A new heartworm medication called ProHeart 6 has been linked to a number of dog deaths, an NBC 5 investigation finds.
Since it was approved in May 2001, the U.S. Food and Drug Administration has received more than 5,000 reports of adverse reactions -- 491 of them deaths.
Now, the FDA is investigating.

Debra McMullen has other dogs now, but says none can take the place of Sassy, the Chihuahua who moved across the country with her. "She was my baby. I don't have childrecMullen asked her veterinarian about the six-month injection called ProHeart 6. She wondered if her 11-year-old dog was too old. "And he said, 'No, that shouldn't matter. She's fine.' And he gave her the shot and the very next day she started having breathing problems," McMullen said.

Two weeks later, Sassy was dead.

Chief was dead just days after his only ProHeart 6 injection, according to his owner. Eric Williams raised the 9-year-old Rottweiler from a pup. "For a completely healthy dog, in the space of three or four days, to go through what I saw Chief go through is not right," Williams said.

Canine Heartworm Medication Adverse Reaction Comparisons

(Source, FDA, As of 5/03/2004)
DrugTotal Adverse ReactionsTotal DeathsYear ApprovedAvg. ReactionsAvg.
ProHeart 6
(Milbemycine oxime):19228419952149Oral
(Milbemycine oxide/luferon):8922519992336Oral

FDA figures show the number of ProHeart 6 adverse reaction reports of deaths to be much higher than monthly heartworm medications -- an average of 138 a year compared with as few as 6 for Heartgard and Sentinel.
Chief had tested positive for heartworms before receiving ProHeart 6 in May  2002.
Manufacturer Fort Dodge Animal Health has since strengthened label warnings against using the preventive on dogs already carrying the parasite. During the past two years, the FDA has ordered three label changes and two "Dear Doctor" warning letters about possible adverse reactions. Experts say the concern is that the medication is a highly concentrated, microencapsulated drug that must be mixed in suspension for time release inside the animal's body.

"[It] needs to be administered properly. It needs to be prepared properly," said Dr. Bert Childers, a veterinarian with the Society for the Prevention of Cruelty to Animals.  Childers has used ProHeart 6 in the past without trouble, and still considers it safe. But his SPCA clinic does not dispense it, in favor of monthly treatment. "You can stop, and you don't have another 4 months left in the body that you
have to contend with," he said.

The company says dogs would be in greater danger missing heartworm treatment. According to Fort Dodge, adverse reaction reports are less than one percent of more than 14 million doses given, and that most death reports are not actually proven to be from ProHeart 6.  In fact, Sassy and Chief were cremated. Their owners can prove nothing with only their ashes. And both their veterinarians told them ProHeart 6 was not the cause.
However, independent veterinarians told NBC 5 that the symptoms suggest otherwise.
"This is probably an adverse reaction from that," Childers said.  "Stop the sale until they find out what's going on," Williams said. Meanwhile, the FDA says it is "actively" investigating.

The FDA also recommends that pet owners should talk to their vet and read current warnings carefully before deciding which treatment to use. For more information, or to report adverse reactions, please refer to the
links below.

On The Net: FDA Veterinary Adverse Reaction Reporting
On The Net: Current ProHeart6 Product Label
On The Net: ProHeart6 FAQ
FDA-Required "Dear Doctor" Letters From Fort Dodge:
Letter 1 | Letter 2
On The Net: FDA ProHeart 6 Application Information
On The Net: FDA ProHeart6 Supplemental Information
On The Net: Heartworm Information


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