Oakland, CA—Although pentosan polysulfate sodium has been prescribed for decades for interstitial cystitis, new research is raising alarms about related ophthalmological issues.

A presentation at the American Academy of Ophthalmology’s (AAO) annual meeting suggests the drug can be toxic to the retina. After an initial report last year that pentosan polysulfate sodium, marketed as Elmiron, might be associated with retinal damage, three ophthalmologists conducted a review of patients at Kaiser Permanente in Northern California, and presented their results at the AAO annual meeting in San Francisco.

More than 1 million people in the United States, mostly women, are estimated to have the condition. Elmiron is the only FDA-approved medication to treat interstitial cystitis, which affects more than a million patients in the U.S., most of them women.

Last year, Nieraj Jain, MD, of Emory Eye Center in Atlanta, reported that six patients who had been taking Elmiron for about 15 years had developed unusual changes in their macula, the central part of the retina responsible for delivering clear, crisp, central vison.

That led to the research by Robin A. Vora, MD, Amar P. Patel, MD, and Ronald Melles, MD, Kaiser Permanente ophthalmologists. They examined the health plan’s population of 4.3 million patients, finding 140 patients who had taken an average of 5,000 pills each over the course of 15 years.

With 91 of the patients coming in for an exam, the researchers divided imaging into three categories: normal, possible abnormality, and definite abnormality. Clear signs of drug toxicity were identified in 22 of the patients. The study team also suggested that the rate of toxicity rose with the amount of drug consumed, from 11% of those taking 500 to 1,000 grams to 42% of those taking 1,500 grams or more.

Researchers also note that medication toxicity might be hard to identify because it could masquerade as other known retinal conditions, such as age-related macular degeneration or pattern dystrophy.

“It‘s unfortunate,” Dr. Vora said. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”

Researchers recommend patients on the drug be screened for retinal damage yearly, even if they don’t show signs of retinal damage.

The study also advises that the damage mighty be mitigated by stopping the medication, but, in the late-stage, toxicity can be similar to late-stage dry atrophic age-related macular degeneration and result in permanent vision loss.

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