Petition for Safer, More Accurate Labeling of Topical Steroids

Petition for Safer, More Accurate Labeling of Topical Steroids

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B. Banos started this petition

Topical steroids are used as a mainstay, firstline treatment for many skin ailments including eczema, psoriasis, contact dermatitis and other allergic responses of the skin. They come in many different preparations including creams, ointments, oils, gels, and lotions. Some are sold over-the-counter; others require a doctor’s prescription.

We ask on behalf of the millions of topical steroid users worldwide that the Food and Drug Administration (FDA) provide safe, clear, complete prescribing and usage guidelines. Patients are experiencing adverse effects due to unclear usage guidelines on labels.

Patients have the right to informed consent and they need to understand the risks as well as the benefits of the drug that they are prescribed and use.

Gaps in labeling include:

  • No clear dose, or maximum dose
  • No unit of measure (fingertip units are not mentioned on the label)
  • No definition of  a “large area” after warning not to use on large areas
  • No definition of a “long period of time” after warning not to use for long periods of time
  • No details on how often to take breaks, or how long breaks should be before resuming treatment
  • No mention of potency or class (Class I Super Potent topical steroids are approximately 600 to 1,000 times stronger than Class VII low potency topical steroids)
  • The phrase ‘Or as directed by your doctor’ allows physicians to override age recommendations and other usage guidelines
  • No warning of the risk of Topical Steroid Withdrawal (TSW) Syndrome as an adverse effect

The vague language of usage guidelines leaves both patient and doctor guessing about parameters of safe use. Patients have the right to access:

  • Packaging and leaflets that prominently label products as corticosteroid medications
  • Clear usage instructions and dosage (max dose, time limits, and parameters around breaks)
  • Guidelines for linking dose with monitoring (body area, length of time, number of fingertip units, applications per day, use without breaks) 
  • Warnings about TSW Syndrome as an adverse effect
  • A Drug Safety Update to inform prescribing physicians of the potential risk of TSW Syndrome.

We urge the FDA to make these changes. Without these basic patient rights, there will continue to be misuse of topical steroids by prescription, and patients will continue to be harmed. We must come together to bring about this much needed change. Sign the petition today to protect another person’s tomorrow.

 Learn more about topical steroids and Topical Steroid Withdrawal Syndrome at ITSAN.org 

 

 

 

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