You are here

Pentosan polysulfate sodium (Elmiron)

Safety advisory - Risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term use

11 October 2021

The sponsor, in consultation with the Therapeutic Goods Administration (TGA), has added a warning about pigmentary maculopathy, or changes in the retina of the eye, to the Product Information (PI) and Consumer Medicine Information (CMI) for pentosan polysulfate sodium. This is considered a rare side effect for pentosan polysulfate sodium.

Pentosan polysulfate sodium is used to treat bladder pain syndrome (interstitial cystitis) and is marketed in Australia under the brand name Elmiron. People may take the medicine for many years for ongoing relief of symptoms associated with the syndrome.

There are reports in overseas medical literature of rare cases of pigmentary maculopathy, which can lead to visual changes, associated with use of pentosan polysulfate sodium, especially after long-term therapy. In Australia, the Therapeutic Goods Administration has not received any adverse event reports for maculopathy or visual disorders in patients using pentosan polysulfate.

Information for consumers

If you or someone you provide care for takes pentosan polysulfate sodium (Elmiron), be aware of this new safety information.

You may require regular eye examinations to help monitor for changes to your retina. The retina is the membrane that lines the back of your eye. You should tell your doctor if you experience any changes in your vision, such as:

  • difficulty reading
  • changes in the way you see colours
  • blurred vision, and
  • your eyes adjusting more slowly to dim lighting. Further information for consumers is provided in the CMI for pentosan polysulfate sodium.

If you have any questions or concerns about this issue, talk to your doctor or other health professional.

Information for health professionals

If you are treating someone with pentosan polysulfate sodium, be aware of the risk of pigmentary maculopathy and advise them accordingly. Educate them about potential signs and symptoms.

All patients should have regular ophthalmic examinations for early detection of pigmentary maculopathy, particularly those with long-term use of pentosan polysulfate sodium.

If signs of pigmentary maculopathy are detected, treatment cessation should be considered.

Further information for health professionals is provided in the PI for pentosan polysulfate sodium.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.