An independent review panel on Proheart 6 was split (8-7) when asked to make a decision on questions of safety for the profession's only injectable heartworm medication.
The 15-member panel, organized through FDA's Veterinary Medical Advisory Committee (VMAC), was charged with making a recommendation to FDA on the safety of Proheart 6. The medication was recalled voluntarily late last year due to an increase in adverse reaction reporting. Fort Dodge stands behind the safety of its product.
Glickman's data showed a safety profile similar to two other heartworm preventives on the market.
More than half of VMAC members called for further research to more clearly define the reasons behind serious adverse events leading up to the voluntary recall. Other panel members said the compliance benefits outweighed reported adverse event risks.
Some key findings from Glickman's study include:
VMAC members were asked to answer two key scientific questions:
Dr. Rami Cobb, vice president of pharmaceutical research and development for Fort Dodge Animal Health reports "Fort Dodge Animal Health will continue to work closely with the CVM to resolve any remaining concerns with the product. We feel strongly the thorough testing, comprehensive analysis of the related data and findings of independent scientific experts have demonstrated ProHeart 6 is safe and effective."
Dr. Will Novak, chief medical officer with Banfield, says, "Based on Dr. Glickman's analysis of scientific data from more than 7 million canine visits at approximately 400 Banfield full-service hospitals, we believe ProHeart 6 is an extremely safe and effective product in preventing heartworm."
"We are very confident in the safety and efficacy of ProHeart 6, and will continue to provide our relevant data in the event the FDA continues reviewing the product," Novak adds.
Adverse events reported to FDA totaled 5,669, which was reported widely by the national news media. Adverse events resulting in death were reported at 485 before the recall. FDA applies an algorithm to assign probability scores to determine the probability that the drug was the probable reason for the adverse event.
Fort Dodge believes that its data of approximately three unfiltered reports for each 10,000 doses sold and independent data of four reports per 10,000 doses administered is an accurate reflection on what was happening in the field.
The VMAC panel included: Drs. Arthur Craigmill, Susanne Aref, Corrie Brown, Mr. Gregory Jaffe, Jack Sherman, Katrina L. Mealey, John J. McGlone, Lisa Nolan, Mark Papich, Richard A. Sams, Charles L. Bennett, Michael I. Luster, John R. Glisson, Sam Groseclose, Tom Nelson, Michael R. Peterson, M. Gatz Riddell and Lauren A. Trepanier.