ProHeart 6 returns to market after recall

Tag : Veterinary Pharmaceuticals
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In 2004, ProHeart 6, an injectable preventative for heartwormdisease in dogs, was the first-ever veterinary drug under pressureto be voluntarily recalled by the manufacturer (Fort Dodge AnimalHealth). In fact, in retrospect, politics likely contributed to therecall of ProHeart 6 to begin with, and good science has supportedits return, which the FDA announced in early June.

Dr. Bernadette Dunham, director for the Center for VeterinaryMedicine at the U.S. Food and Drug Administration, wasn't in chargeat the FDA when ProHeart 6 was first pulled.

She says, "Fort Dodge Animal Health has conducted studies tofurther evaluate the safety of profile of ProHeart 6 and to providean explanation for reported adverse events. These studies includedadditional toxicological and pharmacologic evaluations, whichsuggested (problems were caused by) the allergenic nature of someof the residual solvents that were utilized in the manufacture ofProHeart 6. As a result, Fort Dodge has changed manufacturingspecification, and there's been a decline of adverse eventreporting in international markets."

What's more, ProHeart 6 is only coming back for veterinarians whoare certified to use the drug. And the drug is not being suggestedfor all dogs.

"The bottom line is seeing less potentially deadly heartwormdisease without dogs suffering adverse responses to the drug," saysDr. Sheldon Rubin, Chicago-based president of the AmericanHeartworm Society. "We have nothing to do with regulation of drugs.I do think the FDA has done an excellent job of carefully putting adrug back into the marketplace which can save lives. Now,veterinarians have another available tool in their arsenal. It's atool that they are properly being trained to use appropriately."

Each prescription for ProHeart 6 will come with a clientinformation sheet with general information about the drug,including potential side affects. I have long called for mandatingthat client information accompany all FDA-approved drugs for pets,just as it's now law that this information accompany humanpharmaceuticals.
Steve Dale welcomes questions/comments from readers. Although hecan't answer all of them individually, he'll answer those ofgeneral interest in his column. Write to Steve at Tribune MediaServices, 2225 Kenmore Ave., Suite 114, Buffalo, NY 14207. Sende-mail to PETWORLD@AOL.com . Include your name, city and state.