ProHeart 6 is Back, Be Warned

According to the FDA, ProHeart® 6 (moxidectin) Sustained Release Injectable for Dogs, a unique heartworm preventive product, is returning to the U.S. market.

The drug’s sponsor, Fort Dodge Animal Health, voluntarily removed the product from the U.S. market and ceased production of it in 2004 because of the Food and Drug Administration’s concerns about reports of adverse reactions to the drug. The reported reactions, which included numerous deaths, were unanticipated and unexplained. FDA requested that the drug be removed from the market until the company and FDA could further investigate the situation and resolve concerns.

Fort Dodge Animal Health has changed the manufacturing specifications for Proheart® 6 to minimize the inclusion of residual solvents in the final product.

Full Release

A few things I wanted to point out:

1. The recall in 2004 was voluntary, but the FDA requested the drug be removed.

2. They changed the manufacturing specifications for Proheart 6 to minimize the inclusion of residual solvents in the final product, not eliminate it. And the product has not changed, only the label has changed. From Proheart 6 FAQ’s: ‘Has the product changed since the voluntary recall? ProHeart 6 has not changed since the voluntary recall, other than a change in the supplier of one of the components of the diluent.' So nothing has changed in the product.

3. Only veterinarians who have undergone in-depth training from Fort Dodge will be allowed to obtain the drug. The in-depth training is a web based seminar.

4. They changed the label and client information sheet to include the adverse reactions. The client information sheet does not mention possible liver and blood disorders or death. It is buried in the small print of the label.

5. Owners must sign a consent form. The consent form only lists the following as possible side effects; severe allergic reactions, change in activity level, seizures, vomiting, diarrhea, weight loss, bleeding, and bruising. Again, it does not mention possible liver and blood disorders or death.

Why would you give this to your dog?

P.S. Fort Dodge also had a recall on one of its rabies vaccinations in July 2006.

More about heartworm preventatives in future posts.