More About the RiskMAP Update
The ProHeart 6 RiskMAP was developed by Zoetis and the FDA to ensure safe, appropriate use to achieve maximum benefits of heartworm disease prevention while minimizing risk to dogs.
- The FDA agreed to revisions of this RiskMAP in 2013, based on a review of safety history over a 4.5-year period.
- ProHeart 6 demonstrated predictable safety and efficacy that remained consistent while its usage levels increased dramatically.
- These data show that ProHeart 6 is a safe and effective product for the prevention of canine heartworm disease.
- The specifics of the RiskMAP are reviewed in a 20-minute training program readily accessible at www.proheart6training.com.
History of ProHeart® 6 (moxidectin)
|2001||ProHeart 6 is introduced in the United States.|
|2002||Decision is made to only use batches of technical material with undetectable residual solvents for manufacturing of product.|
|2003||1 of every 5 dogs on heartworm disease preventatives is receiving ProHeart 6 injections.5|
|2004||The FDA expresses concerns regarding consumer reports of adverse events. ProHeart 6 is voluntarily withdrawn from the U.S. market to further evaluate its safety profile.|
|2005‑2007||The ProHeart 6 safety profile is found to be similar to that of current oral heartworm preventatives.|
|2008||ProHeart 6 is reintroduced in the United States using a RiskMAP (Risk Minimization Action Plan).|
|2008‑2013||ProHeart 6 maintains a predictable, expected adverse event profile that remains consistent as product use steadily increases.|
|2013||The RiskMAP is revised, allowing use in healthy dogs older than 7 years, permitting administration by certified veterinary staff and removing a client consent signature requirement.|
|Today||Zoetis continues education on the proper use of ProHeart 6. More than 30,000 veterinarians and clinical staff have been certified to administer it.|