Mass Torts

03. Elmiron

Elmiron

Elmiron (pentosan polysulfate sodium) is a drug commonly prescribed to treat interstital cystitis, a bladder disorder. interstitial cystisis is part of a group of diseases referred to as “painful bladder syndrome” or bladder pain syndrome. Untreated, interstitial cystitis can cause bladder pressure and bladder and pelvic pain that can range from moderate to severe. The disorder most frequently affects women and can lead to the sensation of needing to go to the bathroom more often.

Doctor and Patient

Elmiron has come under scrutiny after studies linked it to vision problems, described as a type of pigmentary maculopathy, but which sometimes may be diagnosed as macular degeneration or macular or pattern dystrophy. The macula is responsible for central and detailed vision.

Elmiron has no warnings regarding eye problems in its labeling and there are now several dozen adverse events related to eye disorders and vision problems similar to those discussed in the medical literature that have been reported in the FDA.

Symptoms for patients experiencing Elmiron-associated eye damage include:

  • Change in eye color

  • Blurred vision

  • Difficulty reading

  • Difficulty adapting to dim lighting

  • Dark spots in center of vision

  • Straight lines appearing curved or squiggly

  • Muted, less vivid colors

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