Jun 23, 2008 9:47 pm US/Central
Recalled Heartworm Drug Back On The Market
(CBS)
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Recalled heartworm drug ProHeart 6 has been approved for sale again by the FDA, under strict new guidelines.
CBS
If you have a dog, there's something you should know for your pet's sake. Four years ago, a heartworm medication called "ProHeart 6" was taken off the market, following a report by the CBS 2 Investigators about its apparent dangers.
Now, as CBS 2's Pam Zekman reports, the FDA has approved it for sale again, but under strict new guidelines.
More than 5,000 pet owners reported their dogs suffered adverse effects, including severe allergic reactions, vomiting, diarrhea, convulsions, weight loss and auto immune anemia.
Georgene Paulauski said about his dog, "I was horrified. I had no idea what was going on at the time."
Some of the reactions were life threatening.
Dog owner Jim Rentas said, "She wouldn't drink, she wouldn't eat. She started losing her physical strength."
As many as 600 dogs may have died or had to be put to sleep after receiving ProHeart 6.
Dog owner Kim Russ said, "He was foaming at the mouth, he had lost control of his bladder, and he was seizing so bad I thought he broke his back."
The injected drug promises protection against deadly heart worm disease for six months. That's very appealing to pet owners who often forget to give dogs monthly oral medications.
In response to Food and Drug Administration concerns, additional testing was done that showed that residues of solvents in the manufacturing process of ProHeart 6 could be causing allergic reactions. Now steps have been taken to reduce that risk.
This month, the FDA allowed Fort Dodge Animal Health, the makers of ProHeart 6, to distribute it again under a one year plan. The plan has been supported by the American Heartworm Society.
AHS President, Dr. Shelly Rubin said, "It's a major way of reassessing is this drug truly a safe drug."
Under the plan, veterinarians must take an online course. It instructs them that ProHeart 6 is not for dogs with liver disease, pre-existing allergies, or dogs who are sick, debilitated or underweight.
"You don't give it to a dog that's under six months of age, and you don't give it to a dog that's over 7 years of age," Rubin added.
You also don't give it within a month of other vaccinations. "That way if there is a reaction to this drug, it's just due to the drug and not some other compounding problem," Rubin said.
Under the plan, the company must file monthly reports to the FDA about any adverse reactions experienced over the next year.
The manufacturer said that even before the drug was taken off the market, the adverse reactions amounted to only one percent of the 150 million doses sold, and it's confident that this one year reassessment will prove the drug is safe.
Pet owners are urged to consult with their vet. You can also find more information from
Fort Dodge Animal Health and the
FDA.
(© MMIX, CBS Broadcasting Inc. All Rights Reserved.)
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