"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.