U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. . Components of Modified Kramer System.
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Notice: Archived Document
The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.
SGPT/ALT Elevations ProHeart 6 Administration
Deaths: 47Health Status at Time of ProHeart 6 Injection for Dogs with Subsequent SGPT/ALT Elevations or Liver Lesions
SGPT/ALT Elevation ProHeart 6 Administration
No concomitant 50
No concomitant 13
Unknown 8Concomitant Status of Dogs with Elevated SGPT/ALT or Liver Lesions Following ProHeart 6 Administration
PRE-MARKETING Clinical Manifestations,
More diverse populationReasons for Post-Marketing Surveillance
“Approximately 18 million doses of Clinical Manifestations, ProHeart 6 have been sold with more than 12 million doses administered” -Fort Dodge Animal Health (page 31)
Allergy event reporting rate for ProHeart 6 is 2.5 to 3.1 times higher than for Fort Dodge vaccines
Non-allergy event reporting rate for ProHeart 6 is 3.4 to 4.0 times higher than for Fort Dodge vaccines
“ 37-38)The adverse event case fatality rate associated with ProHeart 6 reports is lower than many FDAH pharmaceuticals and similar to case fatality rates for the FDAH canine vaccine product lines including Duramune Max 5/4L. Thus the incidence of death does not appear to be causally related to ProHeart 6 usage.”
Fort Dodge Animal Health, Page 36
Events classified as allergic excluded
Neoplasia cases reviewed by expert
Neurologic, hematologic, and hepatic cases reviewed by experts
Table 4.4.2-1. Rate per 10,000 of Any Adverse Event by Treatment Category