Post-Marketing AE Reports of Post-Marketing AE Reports of Topical Calcineurin Topical Calcineurin Inhibitors Inhibitors Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee Marilyn R. Pitts, Pharm.D., Marilyn R. Pitts, Pharm.D., Safety Evaluator, Office of Drug Safety Safety Evaluator, Office of Drug Safety October 30, 2003 October 30, 2003 Center for Drug Evaluation and Research Center for Drug Evaluation and Research
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Post-Marketing AE Reports of Topical Calcineurin Inhibitors Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee Marilyn R. Pitts,
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Post-Marketing AE Reports of Post-Marketing AE Reports of Topical Calcineurin InhibitorsTopical Calcineurin InhibitorsPost-Marketing AE Reports of Post-Marketing AE Reports of Topical Calcineurin InhibitorsTopical Calcineurin Inhibitors
Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee
Marilyn R. Pitts, Pharm.D.,Marilyn R. Pitts, Pharm.D.,Safety Evaluator, Office of Drug SafetySafety Evaluator, Office of Drug Safety
October 30, 2003October 30, 2003
Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee
Marilyn R. Pitts, Pharm.D.,Marilyn R. Pitts, Pharm.D.,Safety Evaluator, Office of Drug SafetySafety Evaluator, Office of Drug Safety
October 30, 2003October 30, 2003
Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research
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OutlineOutline
• Background • Drug Use• Methods• AERS Adverse Event Profile
# Prescriptions & Appearances # Prescriptions & Appearances IMS Health National Prescription Audit IMS Health National Prescription Audit PlusPlusTMTM, ,
IMS National Disease & Therapeutic Index AuditIMS National Disease & Therapeutic Index AuditTMTM
# Prescriptions & Appearances # Prescriptions & Appearances IMS Health National Prescription Audit IMS Health National Prescription Audit PlusPlusTMTM, ,
IMS National Disease & Therapeutic Index AuditIMS National Disease & Therapeutic Index AuditTMTM
Since Approval Pimecrolimus
1%
Topical Tacrolimus
0.03%, 0.1%
Total Rx 3,230,000 2,004,000
Appearances0 to 2 yrs 17% 8%
Appearances3 to 16 yrs 36% 29%
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Some Common Elements in Some Common Elements in Product LabelingProduct Labeling
Some Common Elements in Some Common Elements in Product LabelingProduct Labeling
Pimecrolimus 1%
Topical Tacrolimus
0.03% + 0.1%
Varicella zoster Yes Yes
Herpes Simplex Yes Yes
Eczema herpeticum Yes Yes
Lymphadenopathy Yes Yes
Local Skin rxn Yes Yes
Systemic Absorption Yes Yes
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AERS Electronic DatabaseAERS Electronic Database
– Adverse Event Reporting System
• 1969 – SRS
• 1997 – replaced by AERS
• ~ 3 million AE reports for drugs–Medwatch forms
– Adverse Event Reporting System
• 1969 – SRS
• 1997 – replaced by AERS
• ~ 3 million AE reports for drugs–Medwatch forms
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MethodsMethods
Separate search of AERS database:
– All reports with pimecrolimus as suspect agent
– All reports with tacrolimus administered topically as suspect agent
Separate search of AERS database:
– All reports with pimecrolimus as suspect agent
– All reports with tacrolimus administered topically as suspect agent