PostMarketing AE Reports of Topical Calcineurin Inhibitors

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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, Pharm.D.,
• Safety Evaluator, Office of Drug Safety
• October 30, 2003

Center for Drug Evaluation and Research
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Outline

• Background
• Drug Use
• Methods
• AERS Adverse Event Profile
• Pediatric subgroup
• Death/Hospitalized cases
• Malignant and non-malignant cases
• Infection cases
• Summary

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Topical Calcineurin Inhibitors
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Prescriptions Appearances IMS Health
National Prescription Audit PlusTM, IMS National
Disease Therapeutic Index AuditTM
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Some Common Elements in Product Labeling
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AERS Electronic Database

• Adverse Event Reporting System
• 1969 SRS
• 1997 replaced by AERS
• 3 million AE reports for drugs
• Medwatch forms

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Methods

• Separate search of AERS database
• All reports with pimecrolimus as suspect agent
• All reports with tacrolimus administered
  topically as suspect agent

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Pimecrolimus 1 Cream

• Approved 12/13/2001

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Pimecrolimus Overall Findings (Adult and
Pediatric, n 79)
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Demographics of Pimecrolimus Pediatric Cases
(32)
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Hospitalized Pimecrolimus Pediatric Cases (n 4)
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Pimecrolimus Associated Pediatric Infection Cases
(7)
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Non-Malignant Tumor Growth Pimecrolimus Pediatric
Cases (2)
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Topical Tacrolimus Ointment0.03, 0.1

• Approved 12/08/2000

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Topical Tacrolimus Overall Findings (Adult and
Pediatric, n 183)
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Topical Tacrolimus Death Cases (3)
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Demographics of Topical Tacrolimus Pediatric
Cases (36)
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Topical Tacrolimus Associated Pediatric
Infection Cases (10)
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Malignancies Associated with Topical Tacrolimus
(5)
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Overall Summary Pimecrolimus Topical Tacrolimus

• AERS Post-Marketing AE Reports
• Serious Outcomes
• Malignancies
• Infections
• Pediatric AE Reports
• off label use in children lt 2 years old
  (pimecrolimus, topical tacrolimus)
• adult topical tacrolimus product use in children

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Acknowledgements

• Mark Avigan, M.D., C.M., Acting Director, DDRE,
  Office of Drug Safety
• Renan Bonnel, Pharm.D., M.Ph., Safety Evaluator,
  DDRE, Office of Drug Safety
• Claudia B. Karwoski, Pharm.D., Team Leader, DDRE,
  Office of Drug Safety
• Division of Dermatological and Dental Drug
  Products
• Office of Counter-Terrorism and Pediatric Drug
  Development