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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 It was current when produced, but is no longer maintained and may be outdated.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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U s food and drug administration
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 It was current when produced, but is no longer maintained and may be outdated.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
Components of Modified Kramer System

  • Previous Experience (-1, 0,+1)

  • Alternative Etiologic Candidate (-1, 0, +2)

  • Timing (-2, 0, +1)

  • Overdose (0, +1)

  • Dechallenge (-1, 0, +1)

  • Rechallenge (-1, 0, +1)


Interpretation of range
Interpretation of Range

  • -6 to -1 Remotely drug related

  • 0 to +2 Possibly drug related

  • +3 to +5 Probably drug related

  • +6 to +7 Definitely drug related



Anaphylaxis anaphylactoid reactions
Anaphylaxis/Anaphylactoid Reactions


Onset times of anaphylaxis anaphylactoid reactions proheart 6
Onset Times of Anaphylaxis/ Anaphylactoid Reactions (ProHeart 6)


Health status of dogs with anaphylaxis anaphylactoid reactions at time of proheart 6 administration
Health Status of Dogs with Anaphylaxis/Anaphylactoid Reactions at Time of ProHeart 6 Administration

  • GOOD 1,741

  • Fair 69

  • Poor 3

  • Unknown 7

    Deaths: 54


Concomitant Status of Dogs with Anaphylaxis/Anaphylactoid Reactions at Time of ProHeart 6 Administration

  • No concomitant 816

  • Concomitant 731

  • Unknown 273




Mean serum moxidectin levels following a single injection
Mean Serum Moxidectin Levels Following a Single Injection


Health status of dogs with convulsions following proheart 6 administration
Health Status of Dogs with Convulsions Following ProHeart 6 Administration

  • GOOD 302

  • Fair 64

  • Poor 7

  • Unknown 5

    Deaths: 61


Concomitant status of dogs with convulsions following proheart 6 administration
Concomitant Status of Dogs with Convulsions Following ProHeart 6 Administration

  • No concomitant 87

  • Concomitant 215

  • Unknown 76



SGPT/ALT Elevations ProHeart 6 Administration

GOOD 149

Fair 36

Poor 6

Unknown 1

Deaths: 38

Liver Lesions

GOOD 50

Fair 13

Unknown 2

Deaths: 47

Health 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

Concomitant 112

Unknown 30

Liver Lesions

No concomitant 13

Concomitant 44

Unknown 8

Concomitant Status of Dogs with Elevated SGPT/ALT or Liver Lesions Following ProHeart 6 Administration


Onset times of elevated sgpt alt and liver lesions proheart 6
Onset Times of Elevated SGPT/ALT and Liver Lesions ( ProHeart 6 AdministrationProHeart 6)



Onset times for low platelets and imha proheart 6
Onset Times for Low Platelets and IMHA ( ProHeart 6 AdministrationProHeart 6)


Health status at time of proheart 6 injection for dogs with low platelets or imha
Health Status at Time of ProHeart 6 AdministrationProHeart 6 Injection for Dogs with Low Platelets or IMHA

LOW PLATELETS

  • GOOD 91

  • Fair 28

  • Poor 4

  • Unknown 1

    Deaths: 45

IMHA

  • GOOD 56

  • Fair 10

  • Poor 1

    Deaths: 34


Concomitant status of dogs with low platelets or imha following proheart 6 administration
Concomitant Status of Dogs with Low Platelets or IMHA Following ProHeart 6 Administration

LOW PLATELETS

  • No concomitant 26

  • Concomitant 76

  • Unknown 22

IMHA

  • No concomitant 19

  • Concomitant 34

  • Unknown 14


Number of proheart 6 ade reports received by cvm by year july 1 2001 to june 30 2004
Number of Following ProHeart 6 AdministrationProHeart 6 ADE Reports Received by CVM, by Year (July 1, 2001 to June 30, 2004)


Number of Dogs with Reported ADEs and Number of Reported Dog Deaths ProHeart 6, by Year (July 1, 2001 to June 30, 2004)


Number of Causality Assessments for Certain Reported Clinical Manifestations, ProHeart 6, by Year (July 1, 2001 to June 30, 2004)


Reasons for post marketing surveillance

PRE-MARKETING Clinical Manifestations,

Limited size

Controlled population

POST-MARKETING

Larger size

More diverse population

Reasons for Post-Marketing Surveillance


Post approval concerns for drug safety
Post-Approval Concerns Clinical Manifestations, for Drug Safety

  • Frequency of events

  • Severity of events

  • Temporal association with administration

  • Correlation with rising or peak serum levels

  • Ongoing serious events despite regulatory measures


Additional considerations
Additional Considerations Clinical Manifestations,

  • ProHeart 6 is used with the intent of preventing disease

  • Other alternatives exist

    • fewer reported serious adverse effects


Analysis of proheart 6 adverse events by fort dodge animal health

Analysis of Clinical Manifestations, ProHeart 6 Adverse Events by Fort Dodge Animal Health


“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)


Fdah allergy event reports per 10 000 doses sold pages 37 38
FDAH Allergy Event Reports per 10,000 doses sold (pages 37-38)

  • ProHeart 6: 1.26

  • Duramune Max 5/4L vaccine: 0.4

  • Rabvac 3 vaccine: 0.5

    Allergy event reporting rate for ProHeart 6 is 2.5 to 3.1 times higher than for Fort Dodge vaccines


Fdah non allergy event reports per 10 000 doses sold pages 38 39
FDAH Non-Allergy Event Reports 37-38)per 10,000 doses sold (pages 38-39)

  • ProHeart 6: 1.19

  • Duramune Max 5/4L vaccine: 0.3

  • Rabvac 3 vaccine: 0.35

    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


Fort dodge s causality analysis of medical events by selected body systems page 39
Fort Dodge’s Causality Analysis of Medical Events by Selected Body Systems (page 39)

Possible

Unlikely

Events classified as allergic excluded

Potential

Probable

Neoplasia cases reviewed by expert

Neurologic, hematologic, and hepatic cases reviewed by experts


Analysis of banfield data
Analysis of Selected Body Systems (page 39)Banfield Data

Limitations

  • Selection bias

  • Information bias

Table 4.4.2-1. Rate per 10,000 of Any Adverse Event by Treatment Category


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