ProHeart 6 available with fewer restrictions

ProHeart 6, an injectable drug that provides six months of heartworm prevention in dogs, has become available with fewer restrictions on its administration.

Manufacturer Zoetis made the announcement Aug. 28. According to Zoetis, the revisions to the Risk Minimization Action Plan for the drug are the result of safety history between June 1, 2008, and Dec. 31, 2012. Zoetis develops the RiskMAP, and the Food and Drug Administration approves the plan. The new RiskMAP allows use of the drug in healthy dogs older than 7 years, permits administration by veterinary technicians and assistants who complete online training and certification, and removes the requirement to obtain written client consent.

In September 2004, the FDA expressed concerns regarding reports of adverse events in dogs following use of ProHeart 6. The drug was voluntarily re-called from the U.S. market.

Additional studies of the drug to further evaluate safety included an epidemiologic study that found ProHeart’s safety profile to be similar to two oral heartworm preventives. Further evaluation suggested a potential allergenic nature of residual solvents in the drug. After modifications in the manufacturing process, there was a decline in reports of adverse events in the international market.

In June 2008, ProHeart 6 was reintroduced to the U.S. market under the original RiskMAP. Prescribing veterinarians still must complete online training and certify they have read and understand the current label, conditions of use, and requirement to report adverse events.

Additional information is here.