其 他 安 全 警 示
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| The United Kingdom: Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathy (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that cases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses.
Pentosan polysulfate is indicated in the UK for the treatment of bladder pain syndrome (interstitial cystitis) characterised by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency, and frequency of micturition. The recommended dose of pentosan polysulfate sodium is 300 mg per day, taken as one 100 mg capsule orally three-times daily.
A recent review of cumulative safety information identified rare cases of pigmentary maculopathy after use of pentosan polysulfate in patients with a diagnosis of interstitial cystitis (also known as bladder pain syndrome). The product information in the UK has been updated to include this risk.
In most cases, patients had used pentosan polysulfate long-term and at a dosage exceeding the recommended dose. In a recent retrospective study, patients with pigmentary maculopathy had a median length of exposure to pentosan polysulfate of 18.3 years with a range of 3.0–21.9 years.
Healthcare professionals are advised:
- Rare cases of pigmentary maculopathy have been reported in patients using pentosan polysulfate, particularly after long-term use at high doses.
- Given the potentially irreversible nature of visual loss in pigmentary maculopathy, ensure patients taking pentosan polysulfate have regular ophthalmic examinations during treatment (for example, at baseline and annually).
- Advise patients on pentosan polysulfate to promptly seek medical advice in case of visual changes such as reading difficulty or slow adjustment to low or reduced light environments.
- Consider stopping treatment in patients with pigmentary maculopathy.
Please refer to the following website in MHRA for details:http://www.gov.uk/drug-safety-update/elmiron-pentosan-polysulfate-sodium-rare-risk-of-pigmentary-maculopathy
In Hong Kong, there is no registered pharmaceutical product containing pentosan polysulfate sodium taken orally.
Ends/Friday, Sep 20, 2019
Issued at HKT 16:30
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