Long-term use of the drug Elmiron (pentosan), used to treat bladder pain and discomfort caused by interstitial cystitis (IC), has been linked with an increased risk of pigmentary maculopathy, a vision disorder that affects the macula.
Patients currently using this medication, or who used it in the past, may want to talk to their doctors about the drug’s potential risks to their vision.
Elmiron the Only Drug Made Specifically to Treat IC
The U.S. Food and Drug Administration (FDA) first approved Elmiron in September 1996 as a prescription drug for the treatment of interstitial cystitis, a chronic bladder disease that can cause severe bladder pain, pelvic pain, and urinary frequency. Patients take one 100 mg capsule three times a day to obtain relief of these symptoms. Typically, a three-month-long introductory period is required before the effects begin to take place, and then patients must continue to take the drug indefinitely.
To date, Elmiron is the only FDA-approved drug specifically for the treatment of IC. It’s thought to help restore the health of the inner surface of the bladder, which then protects the bladder wall from urinary substances that irritate it.
What is Pigmentary Maculopathy?
In a 2018 study published in the scientific journal Opthalmology, scientists revealed that chronic exposure to Elmiron (pentosan polysulfate sodium or PPS) was associated with an increased risk of “pigmentary maculopathy”, an unusual form of maculopathy. Maculopathy refers to any disorder of the macula, which is the central portion of the retina—the light-sensitive part of the eye.
Though age-related macular degeneration is the most common disease affecting the macula, there are other types as well. Symptoms typically include a loss of central vision, while peripheral vision is usually not affected. Individuals may notice a dark spot in the middle of their vision that grows over time.
Pigmentary maculopathy is connected specifically to the use of Elmiron and involves the development of excess capillaries or pigmented spots over the retina that affect the central vision.
Studies Connect Elmiron with Vision Disorder
In the spring of 2018, the first report of Elmiron-related maculopathy came to light. Neiraj Jain, M.D., and his colleagues wrote a letter to the editor of the Journal of Urology alerting readers to their observations of “vision-threatening retinal changes associated with long-term exposure to PPS” in six of their patients Each patient received a standard dosage of the medication, from 200-400 mg per day, for about 15 years.
After extensive investigation, the doctors determined that these cases were unique, with the condition resembling no other retinal disease. Later that year, the journal Opthalmology published the case series of the six patients.
In 2019, Jain and colleagues published a second case series, identifying 10 patients with a median age of 59 years who had been diagnosed with IC and either were currently using Elmiron or had used it in the past. All of them showed symptoms of pigmentary maculopathy. The researchers encouraged the patients to stop taking the drug.
Scientists at Kaiser Permanente later found that of the 140 of their patients who had taken Elmiron for a minimum of five years, 22 (24 percent) showed eye damage. That study reported that the greater the quantity of Elmiron taken, the greater the damage.
More research is needed, but for now, patients need to be aware of the risks. Elmiron remains the only approved oral medication for IC and has been on the market for more than two decades.
Exclusively focused on representing plaintiffs—especially in mass tort litigation—Roopal Luhana prides herself on providing unsurpassed professional legal services in pursuit of the specific goals of her clients and their families. While she handles complex cases nationwide on behalf of consumers, Ms. Luhana resides with her family in Brooklyn, New York.