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OTC Dermatologic Topical Corticosteroids

OTC Dermatologic Topical Corticosteroids . Charles J. Ganley, M.D. Food and Drug Administration Director, Division of OTC Drug Products March 24, 2005. Why are we meeting?.

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OTC Dermatologic Topical Corticosteroids

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  1. OTC Dermatologic Topical Corticosteroids Charles J. Ganley, M.D. Food and Drug Administration Director, Division of OTC Drug Products March 24, 2005

  2. Why are we meeting? • To discuss the safety data necessary to consider a switch of dermatologic topical corticosteroids from prescription to OTC?

  3. FDA Presentations • Regulatory history of OTC hydrocortisone • Assessment of safety for current Rx dermatologic topical corticosteroid products • Assessment of systemic effects for other categories of steroid products • Testing for HPA axis suppression

  4. Relevant History • Low potency dermatologic topical corticosteroids are currently available OTC • Symptomatic treatment of skin conditions • Use limited to 1 week • Several manufacturers have expressed an interest in switching some dermatologic topical corticosteroids from prescription to OTC • Symptomatic claims similar to current OTC products • Label limits duration of use

  5. Potency of Products • Difference in the potency of prescription dermatologic topical steroids • Potency impacts on efficacy and safety of products • Where do we draw the line between safe versus unsafe products for OTC?

  6. Can all dermatologic topical steroids be used safely OTC? • Some highly potent products used for extended periods or in large amounts may pose a significant risk for developing a serious adverse event(s) • Limiting the duration of use through labeling may be effective for the majority of users • A minority of consumers will use large amounts and/or for durations that exceed label recommendations

  7. What are the safety concerns? • Systemic Effects • HPA axis suppression • Acute adrenal crisis in stress situation • Can occur within weeks of use; use of OTC product may be unknown • Other Systemic Effects (Cushing’s Syndrome) • Osteoporosis, truncal obesity, growth suppression,…. • Severity related to daily dose and duration of therapy • Local Skin Effects

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