Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for idiopathic intracranial hypertension are being added to the product information for all mesalazine products.
If idiopathic intracranial hypertension occurs in patients, discontinuation of mesalazine should be considered.
- idiopathic intracranial hypertension (IIH) has been very rarely reported in patients receiving mesalazine
- the number of reports in the UK is very low
- patients using any form of mesalazine should be warned to look for signs and symptoms of IIH including severe or recurrent headache, visual disturbances or tinnitus
- remain vigilant of signs and symptoms of IIH in patients taking mesalazine and act promptly with a multidisciplinary approach, involving clinicians managing the patient’s mesalazine as well as neurology, neurosurgery and ophthalmology teams as appropriate
- if symptoms of IIH occurs, discontinuation of mesalazine should be considered and management of the symptoms should begin immediately
- caution is advised when prescribing for patients who have previously diagnosed or suspected IIH
- there have been very rare reports of increased pressure within your skull known as idiopathic intracranial hypertension (IIH) in some patients receiving mesalazine
- IIH is not normally life threatening; however, in rare cases can cause serious vision problems which must be monitored and treated where possible
- tell your doctor immediately if you experience progressively more severe and recurrent headache, disturbed vision, ringing or buzzing in the ears, back pain, dizziness, or neck pain, as these could be symptoms of IIH
Mesalazine
Mesalazine is an aminosalicylate and is licensed for the treatment of inflammatory bowel disease such as ulcerative colitis and Crohn’s disease.
Mesalazine is currently available in the UK in the following formulations:
- Mesalazine 1g & 2g enema
- Mesalazine 1g actuation rectal foam
- Mesalazine 500 mg & 1, 2 g suppositories
- Mesalazine 1, 1.5, 2, 3, 4 g granules
- Mesalazine 400, 500, 800, 1000, 1200, 1600 mg tablets
Idiopathic intracranial hypertension (IIH)
The majority of patients presenting with IIH have symptoms that include the following. It should be noted that none of these symptoms alone are unique to IIH.
- a headache that is progressively more severe and frequent; the type of headache can be highly variable
- transient visual obscurations (unilateral or bilateral darkening of the vision typically lasting seconds)
- pulsatile tinnitus
- back pain
- dizziness
- neck pain
- visual blurring
- cognitive disturbances
- radicular pain
- typically horizontal diplopia
Diagnosis may be achieved through blood pressure monitoring and ophthalmology examination. However, where diagnostic uncertainty remains, experienced clinicians should be consulted, who may consider brain imaging and/or lumbar puncture.
Following diagnosis, recommendations for the management of IIH include:
Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗