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:
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.