MHRA Alert – Topical Steroids: New Labelling and Withdrawal Risk Reminder

MHRA Safety Update: Topical Steroids

The MHRA has issued an important reminder about topical steroid safety, with new labelling coming to products in the coming months. While these medications are safe and effective for managing inflammatory skin conditions, prolonged use—especially at high potency—carries significant risks that all clinicians and responders should be aware of.

Key Safety Points

• Topical steroids are highly effective but require careful risk assessment, particularly for prolonged use
• Topical Steroid Withdrawal Reactions (TSWR) are a recognised and potentially severe complication of long-term use
• New labelling will be introduced to help healthcare professionals and patients understand these risks more clearly
• High-potency formulations carry greater risk and require stricter monitoring
• Patient education on correct application and duration is essential to prevent misuse

Clinical Implications

Responders and clinicians should be alert to presentations consistent with TSWR, particularly in patients with a history of prolonged topical steroid use. Symptoms can include severe erythema, burning, and paradoxical worsening of the original condition upon cessation or dose reduction.

Recommended Actions

• Review your local protocols for topical steroid prescribing and counselling
• Ensure patients understand the importance of using the lowest effective potency for the shortest duration
• Document baseline skin condition and monitor for adverse effects at follow-up
• Be prepared to recognise and manage TSWR in clinical settings
• Stay alert for the new labelling rollout and update patient information materials accordingly

Further Information

For the full MHRA safety update, visit the MHRA Drug Safety Update page.