MHRA Alert – Mesalazine and Idiopathic Intracranial Hypertension Risk

Safety Update: Mesalazine and Idiopathic Intracranial Hypertension

The MHRA has identified a very rare but important safety signal: idiopathic intracranial hypertension (IIH) has been reported in patients treated with mesalazine. Following review, warnings for IIH are now being added to the product information for all mesalazine products.

What You Need to Know

• IIH is a rare neurological condition characterised by raised intracranial pressure without an identifiable cause
• Cases have been very rarely reported in mesalazine users
• The MHRA has strengthened product warnings to alert healthcare professionals and patients to this potential risk
• This is a precautionary measure to ensure informed prescribing and patient monitoring

Affected Medications

All mesalazine-containing products are affected by this safety update, including oral formulations and topical preparations used in inflammatory bowel disease management.

Recommended Actions

• Review patients currently taking mesalazine, particularly those with headache, visual disturbances, or other neurological symptoms
• Be alert to symptoms suggestive of IIH: persistent headache, visual changes, tinnitus, or neck stiffness
• Counsel patients to report new or worsening headaches and visual symptoms promptly
• Refer to updated product information for contraindications and monitoring guidance

Further Information

For the full MHRA safety alert and detailed product information updates, visit the MHRA Drug Safety Update.