In 2004, Fort Dodge Animal Health voluntarily recalled it’s ProHeart 6 heartworm medication because of adverse affects in dogs who were given the medication. The FDA is now allowing that medication to be sold again, with some limitations.

The U.S. Food and Drug Administration (FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death.

ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, manufactured by Fort Dodge Animal Health, Overland Park, Kan., is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.

“This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs,” said Bernadette Dunham, D.V.M., Ph.D., director, FDA’s Center for Veterinary Medicine. “While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions.”

Here’s the rest.

For more information about heartworms see the American Heartworm Society or the Veterinary Information Network.

Technorati Tags: Proheart 6, pets, heartworms, cats, dogs