Severe cutaneous adverse reactions (SCAR) - SJS, TEN and DRESS - are rare but serious risks of deferasirox therapy. Early recognition and immediate discontinuation are life-saving.
1. Early Warning Signs #
- Fever (often 38-40 degrees C)
- Malaise / flu-like symptoms
- New rash, especially with blisters
- Mucosal involvement (eyes, mouth, genitals)
- Lymphadenopathy
- Eosinophilia (in DRESS)
- Hepatitis or nephritis (in DRESS)
2. Defining the Syndromes #
| Syndrome | Hallmark |
|---|---|
| SJS | Epidermal detachment < 10% BSA + mucosal involvement |
| SJS/TEN overlap | Detachment 10-30% BSA |
| TEN | Detachment > 30% BSA - life-threatening |
| DRESS | Rash + fever + lymphadenopathy + eosinophilia + multi-organ involvement |
3. Time Course #
SCAR typically occurs within the first weeks to 2-3 months of therapy. DRESS can present later (up to 8 weeks).
4. Immediate Action #
- Stop deferasirox immediately
- Refer urgently to hospital / dermatology / specialist care
- Do not re-introduce deferasirox - cross-reactivity risk in SCAR
- Supportive care: fluids, pain management, wound care, ophthalmic care, secondary-infection surveillance
- Report as a serious adverse event to the pharmacovigilance authority and manufacturer
5. Patient Counselling at Initiation #
- Describe warning signs in plain language
- Provide a written patient card to carry
- Instruct patient to seek urgent care for rash + fever
- Reinforce: do not self-continue deferasirox if warning signs appear
6. Pharmacovigilance Reporting #
Report suspected SCAR to the local pharmacovigilance authority and to manufacturer safety team. Contribution to signal detection improves patient safety globally.
See Safety Profile.