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Topical Corticosteroid Adverse Events in Pediatric Patients Analysis of Postmarketing Reports

This analysis examines postmarketing reports of adverse events in pediatric patients caused by topical corticosteroids. The study highlights the limitations and strengths of the Adverse Event Reporting System (AERS) and provides insights into the potency and classification of topical corticosteroids. The results of the cases demonstrate the importance of vigilant reporting and monitoring of adverse events in pediatric patients using topical corticosteroids.

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Topical Corticosteroid Adverse Events in Pediatric Patients Analysis of Postmarketing Reports

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  1. Topical Corticosteroid Adverse Events in Pediatric PatientsAnalysis of Postmarketing Reports Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee Claudia B. Karwoski, Pharm.D., Safety Evaluator, Office of Drug Safety October 29, 2003 Center for Drug Evaluation and Research

  2. Outline • Background • Overview of AERS • Limitations • Strengths • Potency of topical corticosteroids • Methods • Results of Cases • Summary

  3. Adverse Event Reporting System • Spontaneous, voluntary surveillance system • Voluntary reporting by health care professionals and consumers • Mandatory reporting by manufacturers • Approximately 3 million reports in database • Database origin 1969 (SRS) • AERS implementation Nov 1997 • Contains human drug and “therapeutic” biologic reports • exception = vaccines (VAERS)

  4. Adverse Event Reporting SystemLimitations • Quality of report is variable and often incomplete • Subject to under-reporting (true numerator not known) • Reporting biases exist • Exact denominator (# of exposed patients) is not known • spontaneous report numbers cannot be used to determine incidence of adverse event • Duplicate reporting occurs

  5. Adverse Event Reporting SystemStrengths • Early detection of events not seen in clinical trials (“signal generation”) • One or more reports can trigger further evaluation of a safety signal • Especially useful for detecting serious, rare events • Case series evaluation: identification of AE trends, drug indication, population, and other clinically significant emerging safety concerns • Relatively inexpensive compared to alternative surveillance strategies

  6. Seven Classes Class I – Superpotent Class II – High Potency Classes III, IV, V, VI – Midpotency Class VII – Low Potency Vasoconstrictor Assay Topical Corticosteroid Classification

  7. Methods • AERS Search • All reports in children 0 to 16 years • Reports of adrenal suppression, Cushing’s syndrome, and growth retardation in children • Literature Search • Published case reports of adrenal suppression, Cushing’s syndrome, and growth retardation in children

  8. Leading Adverse Events in Children Following Topical CS Use (n=244) Based on 2001 review of AERS

  9. Adrenal Suppression, Cushing’s Syndrome, and Growth Retardation • 24 total cases found in AERS and the published literature • 2 excluded • 22 cases evaluated • Adrenal suppression/hypofunction-8 • Cushing’s syndrome-13 • Growth retardation-10 • Six were published in literature

  10. Case Series Characteristics-1

  11. Case Series Characteristics-2 *More than one possible

  12. Case Series Characteristics-3 *More than one product use in 4 cases

  13. Clinical Findings • Presented with: • Weight gain or other Cushingoid features-12 • Growth retardation-10 • Acute adrenal insufficiency-1 • Skin striae and depigmentation-1 • Unknown-1

  14. Laboratory Evidence of Adrenal SuppressionSelected Cases-1

  15. Laboratory Evidence of Adrenal SuppressionSelected Cases-2

  16. Laboratory Evidence of Adrenal SuppressionSelected Cases-3

  17. Factors Affecting Absorption-1 • Size of area • Two reported use on entire body • Three reported use in more than one location • Duration of treatment • 3 months or longer in 11 • More than one year in 7 • Use of occlusive dressing • Probable occlusion by diaper in 7

  18. Factors Affecting Absorption-2 • Small children higher ratio of skin surface to weight • 5 cases involved infants • Thickness of stratum corneum and vascular supply of area • diaper area in 7 cases • 1 case of application to second degree burns

  19. Other Factors • 15 reported use of “superpotent” or “potent” topical corticosteroid products • Use of more than one topical corticosteroid product (4 cases) • Use without medical supervision (4 cases) • Concomitant or prior use of systemic corticosteroid products (2 cases)

  20. Summary • Small number of postmarketing cases • Due to underreporting associated with spontaneous reporting systems • Lack of clinical suspicion • Failure to recognize that topical corticosteroids may be systemically absorbed • Assumption that adrenal suppression is an unusual complication of topical corticosteroid therapy; therefore routine testing not done • Signs and symptoms may be subtle and non-specific; therefore, attribution made to other causes

  21. Acknowledgements Joyce Weaver, Pharm. D., Safety Evaluator, DDRE, Office of Drug Safety Marilyn R. Pitts, Pharm.D., Safety Evaluator, DDRE, Office of Drug Safety

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