I did much research on this subject for my article posted on FindRetrievers in Feb 2010. Click to here to READ it.Since the drug was recalled in September, 2004, the manufacturers (Fort Dodge Animal Health)conducted studies to further evaluate the safety profile of ProHeart® 6 and to investigate thereported adverse events. These studies included additional toxicologic and pharmacologicevaluations which suggested the potential allergenic nature of some of the residual solvents thatare utilized in the manufacture of ProHeart® 6. As a result, Fort Dodge changed themanufacturing specifications for ProHeart® 6 and marketed the modified product in internationalmarkets. In the years following this change, there was a decline in the adverse event reporting ininternational markets. The results of the toxicologic studies coupled with the lower adverse eventfrequency in international markets were factors in FDA’s decision to concur with Fort Dodge’srestricted return of ProHeart® 6 to the U.S. market under a risk minimization and restricteddistribution program (RiskMAP) plan in June, 2008. In addition to the plan, based on post-approval experience, the ProHeart® 6 label and Client Information Sheet were revised to includeupdated safety information.
- ProHeart 6 was released in June 2001 by Fort Dodge Animal Health
- In 2004, at the request of the U.S. Food and Drug Administration Center for Veterinary Medicine(CVM), Fort Dodge Animal Health (FDAH) instituted a voluntary recall of ProHeart 6. CVMexpressed concerns regarding reports of serious adverse events in dogs following use of ProHeart 6.
- Fort Dodge’s restricted return of ProHeart® 6 to the U.S. market under a risk minimization and restricted distribution program (RiskMAP) plan in June, 2008
- Veterinary Medical Advisory Committee meeting March 2010 to review the results of RiskMAP. "The ProHeart 6 RiskMAP was modeled on RiskMAPs in place for some human pharmaceuticalproducts in the US and provided for the collection and evaluation of pharmacovigilanceinformation, including the use of ProHeart 6 without the confounding effect of concurrentvaccinations. Since implementation of the RiskMAP, the adverse reaction rate for ProHeart® 6was ~3 adverse reactions per 10,000 doses distributed. This included all of the reports receivedfor ProHeart 6 regardless of causality or association with the product."
- ProHeart 6 continues to be provided inaccordance with the RiskMAP. "By setting forth a proactive plan of risk minimization activities, the potential for harm associatedwith use of ProHeart 6 was reduced and the benefits of 6-month continuous protection areextended to individual dogs. In addition, the RiskMAP allows for clearer characterization of thesafety profile of ProHeart 6 by eliminating confounding factors such as adverse reactions associated with concurrent vaccination. Regular evaluation of the RiskMAP ensures thatcaptured adverse events are reviewed and analyzed in a timely manner and, if appropriate,mitigated by revising the guidelines for veterinarians to follow when using ProHeart 6."
Proheart 6 is probably one the best studied canine medications on the market.
FDA RiskMAP June 2008 http://www.fda.gov/downloads/Advisor.../UCM202168.pdf
VMAC Meeting March 2010