A study published last fall indicates a link between the long term use of Elmiron and an increased risk of pigmentary maculopathy.

Dr. Nieraj Jain’s findings were published in the November 2018 issue of Ophthalmology. He and his team of researchers at Atlanta’s Emory Eye Center, Emory School of Medicine sent a letter to the editor of the Journal of Urology to alert patients that long-term use of Elmiron may cause eye problems that could be mistaken for other types of macular disease.

Elmiron (pentosan polysulfate sodium) is a prescription medication used to control pain from interstitial cystitis, also known as painful bladder syndrome. Interstitial cystitis primarily affects women and can cause severe bladder and pelvic pain in addition to an increased frequency to urinate. The U.S. Food and Drug Administration (FDA) approved Elmiron in 1996 as a treatment for the painful bladder condition.

Dr. Jain said he found six patients who had taken Elmiron for an average of 16 years, and who developed pentosan pigmentary maculopathy. He evaluated the patients between May 1, 2015, and Oct. 1, 2017. He said the medicine’s link to the potentially blinding condition has been kept under the radar because specific, advanced retinal imagery is needed to diagnose the problem. A regular eye exam could miss the issue.

According to the article published in the American Academy of Opthalmology, patients in the study ranged from age 37 to age 62, with a median age of 60. Most of them said difficulty reading was the most troublesome symptom, followed by problems adapting to dim lighting.

Since the study ended, four more patients have been diagnosed, for a total of 10.

Pentosan Pigmentary Maculopathy Found by Fundus Examination

Pentosan pigmentary maculopathy occurs when abnormal blood vessels enter the area under the retina, where blood may leak and scar the macula.

According to the study, an examination of the fundus found “hyperpigmentation at the level of the retinal pigment epithelium (RPE) with a surrounding array of vitelliform-like deposits.” The fundus of the eye is the interior surface of the eye opposite the lens. The fundus includes the retina, optic disc, macula, fovea and posterior pole. The retinal pigment epithelium is the pigmented cell layer. Vitelliform deposits are tiny lesions that look like yellow or orange spheres under the macula.

Even though Dr. Jain found no evidence of any other cause, he concluded that more investigations are needed to determine why Elmiron would cause such visual deterioration. Patients were tested for any hereditary link to maculopathy, but none was found.

Elmiron also has mild blood-thinning effects. Signs that a patient is experiencing anticoagulant side effects include a nosebleed, coughing up blood, feeling faint, bloody urine or bleeding gums.

Elmiron is a product of Janssen Pharmaceuticals, which lists the drug’s most common side effects as hair loss, diarrhea, nausea, blood in the stool, headache, rash, abnormal liver function tests, dizziness and bruising. Fluid retention also might be a problem, indicated by weight gain and swollen areas of the body.