Patients Taking Elmiron Should be Monitored for Maculopathy Side Effects, Optometrist Warns

During a presentation on the ocular effects of systemic medications, delivered at the Southeastern Educational Congress of Optometry (SECO) 2021 meeting, optometrist and faculty member at Northeastern State University Oklahoma College of Optometry, Nate Lighthizer, OD, FAAO, warned that patients taking the bladder drug Elmiron should be monitored for symptoms of maculopathy, a disease of the eye affecting the central part of the retina, or the macula. If you have been prescribed Elmiron for interstitial cystitis and you have experienced symptoms of maculopathy, such as blurred vision, vision distortion, or difficulty adapting to dim lighting, do not hesitate to seek legal help from a knowledgeable Elmiron injury attorney. With a qualified legal advocate on your side, you may be able to hold the makers of Elmiron accountable for the vision problems you have suffered.

Unique Pigmentary Maculopathy Linked to Bladder Drug

Elmiron (pentosan polysulfate sodium, or PPS) is the only oral treatment available for interstitial cystitis (IC), a bladder condition characterized by painful urination and urinary urgency. More than one million people in the United States suffer from IC, and Elmiron has been widely prescribed for decades to treat the bladder condition, with no warnings about the potential for the drug to cause ocular toxicity. That is, until recently. Over the past few years, evidence has emerged regarding the potential for Elmiron use to trigger a unique pigmentary maculopathy in patients taking the drug long-term, a risk that prompted the FDA to approve a new warning label highlighting the risk of “retinal pigmentary changes” in Elmiron users. “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron,” the new Elmiron warning label states. “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.”

Elmiron Toxicity Observed in Study

During his presentation at the 2021 SECO conference, which was held in Atlanta from April 28 to May 2, 2021, Dr. Nate Lighthizer discussed the potential for chronic exposure to Elmiron to cause pigmentary maculopathy in users, citing a study in which researchers from Emory University looked at 219 patients diagnosed with interstitial cystitis. “Everyone who had pigmentary maculopathy was taking pentosan polysulfate (PPS),” Dr. Lighthizer stated in his presentation. The mean age of ocular toxicity reported in the study was 60 years and the median duration of Elmiron use was 15 to 18 years. “The study also suggested that chronicity of exposure plays a role,” Dr. Lighthizer added. “At the 5-year time point of continuous treatment, there was a trend for increased risk, although it wasn’t statistically significant.”

The most common maculopathy symptoms affecting the Elmiron users in the Emory University study were blurred vision (48%), prolonged dark adaptation (48%), and metamorphopsia (11%), which is a visual defect that makes linear objects appear curved or rounded. The researchers involved in the study noted that “No patient exhibited this maculopathy in the absence of PPS exposure,” stating that, “among all potential risk factors examined, PPS exposure emerged as the sole statistically significant predictor of this maculopathy.” In reviewing the results of this study, Dr. Lighthizer remarked that many cases of Elmiron-related toxicity may have previously been misdiagnosed as other similar eye conditions, such as age-related macular degeneration or pattern dystrophy, which likely delayed the discontinuation of treatment and allowed the maculopathy to progress.

Long-Term Elmiron Users at Risk for Maculopathy

It is estimated that hundreds of thousands of individuals have been exposed to Elmiron in the U.S. and could now be at risk for pigmentary maculopathy side effects. In an effort to reduce the risk of irreversible vision problems in this population, vision screening guidelines have been developed for long-term Elmiron users. According to the guidelines, a baseline exam for these patients should be taken before beginning treatment and annual exams should be conducted after five years of Elmiron use, to check for any macular abnormalities. Optometrists are advised to perform a dilated fundus exam, optical coherence tomography (OCT), fundus photography and fundus autofluorescence (FAF), “the most important test,” Dr. Lighthizer says. Dr. Lighthizer also recommends watching patients more closely if there is concurrent macular disease, kidney or liver issues, or unusually high dosages of the drug. If Elmiron toxicity is observed, optometrists are urged to discuss discontinuing treatment with the prescriber and the patient.