Safety Advisory for Pentosan Polysulfate Sodium

The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding pentosan polysulfate sodium (PPS). The product information has been updated to include a warning that rare cases of pigmentary maculopathy have been reported with this medication, particularly during long-term use. As PPS is used in the treatment of interstitial cystitis, a chronic condition, therapy is typically lengthy.

Pigmentary maculopathy affects the macula, the area of the retina responsible for central vision and much of our fine detail and colour vision. Signs and symptoms of this condition may include:

• Reading difficulty;
• Slow adjustment to dim light;
• Visual disturbances; and
• Eye pain.

While the TGA has not received any reports of maculopathy or visual disorders associated with PPS, cases have been reported in the medical literature. One study demonstrated that the onset of pigmentary maculopathy had a median duration of 15 years exposure to PPS (range of 3-22 years).

The TGA advises that patients taking PPS should be educated about potential signs and symptoms of pigmentary maculopathy. Regular ophthalmic examinations are recommended for all patients taking PPS, and especially those with long-term exposure. Treatment cessation should be considered if signs of pigmentary maculopathy are detected.