OTC Dermatologic Topical Corticosteroids

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OTC Dermatologic Topical Corticosteroids

• Charles J. Ganley, M.D.
• Food and Drug Administration
• Director, Division of OTC Drug Products
• March 24, 2005

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Why are we meeting?

• To discuss the safety data necessary to consider
  a switch of dermatologic topical corticosteroids
  from prescription to OTC?

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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

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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

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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?

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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

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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 (Cushings Syndrome)
• Osteoporosis, truncal obesity, growth
  suppression,.
• Severity related to daily dose and duration of
  therapy
• Local Skin Effects

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