The Corticosteroid Stewardship Alliance has submitted a Citizen Petition to the U.S. Food and Drug Administration calling for updated safety information and clearer guidance for prescription topical corticosteroids.
Topical corticosteroids are important and effective treatments for inflammatory skin conditions. However, many patients use these medications repeatedly or over long periods of time, and current FDA labeling does not fully reflect what is known about cumulative exposure and long-term use.
CSA is asking the FDA to update labeling so patients and health care providers have clearer information to support safe and effective use.
What is a Citizen Petition?
A Citizen Petition is a formal way to ask the FDA to take action on a specific issue. Through this petition, CSA is asking the FDA to modernize prescribing and patient information for prescription topical corticosteroids based on current evidence and real-world use.
CSA is not asking FDA to remove or restrict access to topical corticosteroids. The goal is clearer safety information, more actionable guidance and better communication about the potential risks associated with repeated and long-term use.
What has CSA submitted?
On October 6, 2026, CSA submitted a Citizen Petition requesting updates to prescription topical corticosteroid labeling and guidance communicating updated safety considerations.
The petition addresses issues including cumulative exposure, duration and quantity of use, withdrawal reactions, adrenal suppression, local and ophthalmic effects and other potential long-term risks.
CSA’s petition includes eight requests:
- Update dosage and administration information.
- Add information on topical corticosteroid withdrawal reactions.
- Strengthen warnings and precautions addressing endocrine, local, ophthalmic, infectious and sensitization risks.
- Update postmarketing information to include identified adverse reactions.
- Strengthen information for specific populations, including pediatric and geriatric patients.
- Expand patient counseling information on safe use and potential adverse effects.
- Require a Medication Guide with patient-focused safety information.
- Issue a Dear Health Care Provider letter communicating updated safety information.
CSA Needs Your Voice
The FDA is accepting public comments on the petition, and we encourage patients, caregivers, health care providers and other stakeholders to share their perspectives.
When submitting a comment, you can:
- Share your experience with repeated or long-term topical corticosteroid use.
- Explain why clearer guidance and patient information are important.
- Encourage the FDA to ensure labeling reflects current evidence and real-world use.
Your comment does not need to be long. Your perspective can help the FDA understand why these issues matter.
Example Comment:
“My name is [NAME], and I live with [CONDITION], Over the years, I have used topical corticosteroids as prescribed to manage my condition. While the medication helped control some of my symptoms, I later experienced [COMPLICATION/SIDE EFFECT], which had a significant impact on my health and quality of life.
At the time I began treatment, I was not fully aware of the potential risks associated with repeated or long-term use. If clearer information had been included in the product labeling and patient materials, I would have been better prepared to discuss those risks with my health care provider, monitor for warning signs and make more informed decisions about my treatment.
I support efforts to ensure that FDA labeling reflects current evidence and real-world patient experiences. Clear, transparent information can help patients and caregivers better understand both the benefits and potential risks of treatment and support meaningful conversations with their providers.”
How to Submit Your Comment:
- Click “Submit a comment” to go to the FDA’s public comment portal.
- Select the “Comment” option on the Regulations.gov page.
- Share why you support stronger safety labeling and clearer prescribing guidance. You can write in your own words or use the suggested talking points.
- Share any pictures to go along with your story or any additional information by uploading files under “Attach Files.”
- In the dropdown section on “Comment Category,” choose: Drug Industry
- Under “Tell us about Yourself,” choose the box that best represents you.
- Submit your comment and save your confirmation.
Submit your comment to the FDA. Make your voice heard. Every voice can help inform the FDA’s consideration of the petition.