Elmiron may cause permanent vision loss, updated label warns

Updates to the label for Elmiron®, a medication used to treat bladder pain and inflammation, now warn of potential, permanent damage to the retina that could cause irreversible vision loss.

Manufacturer Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, updated Elmiron’s warning label in June 2020, nearly 25 years after the drug, also known as pentosan polysulfate sodium (PPS) was first approved by the FDA to treat the chronic bladder condition interstitial cystitis (IC), which affects roughly a million American women. The label update comes amid lawsuits and multiple studies, including from the Emory Eye Center and the American Academy of Ophthalmology, that suggest a link between Elmiron and a newly discovered eye disease in patients that is often diagnosed as retinal pigmentary maculopathy, pattern dystrophy, or age-related macular degeneration.

Retinal Pigmentary Changes

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.

Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

Common signs of Elmiron®-associated eye damage may include:

  • Difficulty reading
  • Difficulty adapting to dim lighting
  • Blurred vision (often centrally in the patient's field of vision)
  • Dark spots in center of vision
  • Straight lines appearing curved or squiggly
  • Muted, less vivid colors

According to Elmiron’s updated label, most cases of eye damage occurred after the patient had been taking the drug for at least three years, but cases involving shorter use have also been reported. “The visual consequences of these pigmentary changes are not fully characterized,” the label now states. “Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment.”

Motley Rice attorneys have extensive experience representing patients who have suffered life-altering complications caused by allegedly dangerous medical drugs and devices, including holding litigation leadership positions in suits involving products manufactured by Janssen Pharmaceuticals and Johnson & Johnson.

If you took Elmiron to treat interstitial cystitis and suffered vision loss, consider speaking with a medical attorney as soon as possible so that if you have a claim it can be filed before it is too late and is permanently barred under the applicable statute of limitations, which sets the date by which claims must be filed.

For more information or to discuss a potential case, you may contact medical attorney Carmen Scott by email or call 1.800.768.4026.