Other safety alerts
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| Canada: ELMIRON (pentosan polysulfate sodium) and the risk of pigmentary maculopathy |
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Health Canada announces that cases of pigmentary maculopathy have been reported with long-term use of ELMIRON (pentosan polysulfate sodium). These changes may be irreversible, and retinal and vision changes may progress even after cessation of therapy.
ELMIRON 100mg Capsules is a glycosaminoglycan substitute indicated for the initial and maintenance treatment of interstitial cystitis. Cases of pigmentary maculopathy have been reported with long-term use of ELMIRON. Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision.
ELMIRON is now contraindicated in patients with a personal history of any macular pathology. The Canadian Product Monograph for ELMIRON has been updated to include the new contraindication and further strengthen the information about the risk of pigmentary maculopathy in the Warnings and Precautions (including the new Serious Warnings and Precautions Box) and Consumer Information sections.
Healthcare professionals are advised to:
- Assess the benefits and risks with their patients before initiating treatment with ELMIRON and periodically thereafter.
- Obtain a detailed ophthalmologic history in all patients prior to starting treatment with ELMIRON.
- Consider genetic testing for patients with a family history of hereditary macular pathology.
- Recommend a comprehensive baseline retinal exam including colour fundoscopic photography, ocular coherence tomography, and auto-fluorescence imaging before initiating treatment in patients with pre-existing ophthalmologic conditions.
- Recommend baseline and periodic comprehensive retinal examinations in patients continuing with ELMIRON treatment.
- Counsel patients to report changes in vision such as difficulty reading, slow adjustment to low or reduced light, blurred vision including blurry or wavy vision near or in the centre of the field of vision.
- Consider treatment discontinuation in the event pigmentary maculopathy is confirmed. Perform follow-up retinal examinations as retinal and vision changes may progress even after stopping treatment with ELMIRON.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74549a-eng.php
In Hong Kong, there is no registered pharmaceutical product containing pentosan polysulfate sodium taken orally. Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 20 Sep 2019.
Ends/Wednesday, Dec 16, 2020
Issued at HKT 16:00
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