Most Americans will use a topical corticosteroid treatment at least once in their lives: hydrocortisone cream for poison ivy or a mild rash is basic first aid. For patients with chronic inflammatory skin conditions like eczema and psoriasis, intermittent use over several years contributes to cumulative exposure that can result in harm. The Corticosteroid Stewardship Alliance, or CSA, has asked the FDA to update prescribing information and safety data to reflect the risk associated with long-term use.
Updating Labels for Real-World Care
Emerging evidence suggests large amounts or long-term exposure to topical corticosteroids can increase risk for serious health consequences including osteoporosis, bone fracture, skin damage, type 2 diabetes, adrenal suppression and eye damage, including cataracts, glaucoma, and blindness. Clinicians and patients should be made aware that topical corticosteroid treatments prescribed safely for acute conditions may result in harm and new health concerns if used over longer periods.
The Citizen Petition does not ask FDA to restrict access to steroids or remove them from the market. Instead, the coalition seeks to ensure labeling and prescribing information accurately reflects evolving knowledge about these medications, their use, and interactions in real-world care settings.
From General Warnings to Actionable Guidance
Without a comprehensive framework for long-term use, prescribers may be operating on incorrect or outdated assumptions. Even those aware of the risks often lack actionable guidance about treatment duration, quantity, potency and withdrawal reactions. Safer long-term use relies on accurate information about each of these factors.
The Citizen Petition requests the FDA take specific actions towards promoting continued patient safety. Each measure seeks to empower patients and professionals to make more informed decisions about long-term care. Among these requests are::
- Expand and modernize prescribing information to provide clearer guidance.
- Add patient counseling and medication guides.
- Include new warnings and precautions about adverse reactions.
- Update instructions for pediatric and geriatric patient populations.
The petition also asks the FDA to amend warnings — if needed — to address risks to bone density, eye health and immune response.
How to Make Your Voice Heard
Anyone can participate in the FDA’s rulemaking process by submitting written comments. Vulnerable patients deserve clear safety guidance. Add your voice to the FDA’s public comment process.
