Other safety alerts
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| Australia: Pentosan polysulfate sodium and pigmentary maculopathy |
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The Therapeutic Goods Administration (TGA) announces that the Product Information (PI) for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use.
Pentosan polysulfate sodium is indicated for the treatment of bladder pain syndrome (interstitial cystitis). Relief of symptoms in patients with interstitial cystitis may not be experienced until after 6-8 weeks of therapy. It may be taken for many years for ongoing management of pain, urgency and frequency of micturition associated with the syndrome.
Pentosan polysulfate sodium is marketed in Australia under the brand name Elmiron Capsules.
Rare cases of pigmentary maculopathy have been reported in overseas medical literature with use of pentosan polysulfate sodium, especially after long-term use. Visual symptoms might include complaints of reading difficulty and slow adjustment to low or reduced light environments. In Australia, the TGA has not yet received any adverse event reports of maculopathy or visual disturbances associated with pentosane polysulfate.
Information about this rare but potentially severe adverse event has been added to the PI for pentosan polysulfate sodium in 'Section 4.4 Special Warnings and Precautions for Use' and 'Section 4.8 Adverse Effects', including advice regarding regular monitoring.
Health professionals are advised that, if they are treating someone with pentosan polysulfate sodium, be aware of this potential adverse event and advise them of the risks. All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with long-term use of pentosan polysulfate sodium. In such situations, treatment cessation should be considered.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/pentosan-polysulfate-sodium-and-pigmentary-maculopathy
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 Health Canada, and was posted on the Drug Office website on 20 Sep 2019 and 16 Dec 2020.
Ends/Monday, Oct 11, 2021
Issued at HKT 14:00
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