Pentosan polysulfate sodium and pigmentary maculopathy

Health professionals are advised 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.

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 Therapeutic Goods Administration 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.

Information for health professionals

If you 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.

Further reading

1. Hanif AM, Shah R, Yan J, Varghese JS, Patel SA, Cribbs BE, O'Keefe G, Hendrick AM, Shantha JG, Hubbard GB 3rd, Patel PS, Rao P, Yeh S, Jain N. Strength of Association between Pentosan Polysulfate and a Novel Maculopathy. Ophthalmology. 2019 Oct;126(10):1464-1466.
2. Kalbag, Neil S et al. Maculopathy Secondary to Pentosan Polysulfate Use: A Single-Center Experience. Clinical ophthalmology (Auckland, N.Z.) vol. 15 513-519. 11 Feb. 2021.

What to report? You don't need to be certain, just suspicious!

The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.

We particularly request reports of:

• all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
• all suspected medicines interactions
• suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.

Reports may be submitted:

• online at www.tga.gov.au
• by fax to 02 6232 8392
• by email to ADR.Reports@tga.gov.au

For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.

Editor: Dr Catherine Brogan

Deputy Editor: Mr Michael Pittman

Contributor: Dr Victoria Mansell and Mr Gilbert Yeap