Elmiron Warnings Added to U.S. Label About Retina Pigmentary Changes, Maculopathy

Federal regulators have finally added a label warning alerting doctors and patients about the risk of serious vision side effects from Elmiron, an interstitial cystitis drug that has been linked to reports of a rare retinal disease known as pigmentary maculopathy.

On June 16, the FDA posted a new Elmiron warning label (PDF), which now includes information about retinal pigmentary changes and cases of maculopathy reported in literature among long-term users of the medication.

Similar vision loss warnings were added to Canadian version of the drug back in October 2019, but this is the first time the information has been added to labels in the United States, or provided by the U.S. drug maker for consumers and the medical community.

Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and has been promoted as a safe and effective treatment for interstitial cystitis or “painful bladder syndrome”, which is a chronic condition with no known cure, resulting in most users staying on the treatment for years, or even decades.

Over the past year, a series of studies and case reports have been published by independent researchers linking Elmiron side effects to pigmentary maculopathy, which may cause permanent vision loss, blurry vision, dark spots and prolonged adaption to dim light.

The new warnings on the U.S. labels refer to the problem as “Retinal Pigmentary Changes”, noting that scientific literature links long-term use to pigmentary maculopathy.

“Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use,” the warning indicates. “While the etiology is unclear, cumulative dose appears to be a risk factor.”

The warning gives a list of visual symptoms, including difficulty reading, slow adjustment to low light environments and blurred vision. It also warns that healthcare professionals should use caution in diagnosing patients who may have retinal pigmentary changes due to other causes, and recommends they obtain a detailed ophthalmologic history for all patients before beginning them on Elmiron treatment.

Macular retinopathy from Elmiron results in deterioration in the retina where vision is keenest, causing a loss of detailed vision over time. Since the retina is especially susceptible to the effects of systemic drugs like Elmiron, and has minimal ability to regenerate, critics point out that updated Elmiron warnings were critical to ensure that users are carefully monitored for changes in vision. However, due to a lack of label warnings in the United States until now, many doctors are only now beginning to learn about the risks, and in most cases consumers remain unaware of the potential vision loss side effects.

Over the coming weeks and months, hundreds, if not thousands, of Elmiron vision loss lawsuits may be filed by former users, alleging that they may have avoided permanent retinal damage if earlier warnings had been provided about the risks associated with use of the drug and the importance of monitoring for symptoms.