Elmiron Dangers

By Rheingold Giuffra Ruffo & Plotkin LLP

Elmiron, manufactured and marketed by Janssen Pharmaceuticals, is a drug intended to treat interstitial cystitis (IC), a condition that affects more women than men and causes pain and pressure in the bladder. In June 2020, Janssen Pharmaceuticals added a warning for retinal pigmentary maculopathy, a condition that causes vision problems.

However, research has found that Elmiron has been associated with a serious eye disease known as retinal maculopathy.  It was discovered by researchers associated with the Emory Eye Center at Emory University Medical School in Atlanta, Georgia.

Researchers at Emory observed those who were treated for interstitial cystitis associated with Elmiron long-term use between 2015 and 2017 were at an increased risk for developing retinal maculopathy. These people reported significant difficulty reading as well as adapting in low-light situations. The researchers concluded that a connection exists between this form of maculopathy and chronic exposure to PPS and it merits further investigation.

A warning label for the prescription drug Elmiron was approved by the U.S. Food and Drug Administration (FDA). The FDA warning follows multiple reports of patients who developed pigmentary changes including retinal maculopathy after taking Elmiron. Until now, the manufacturer’s label did not include any warnings for retinal damage. Now the label indicates that “retinal pigmentary changes” can occur. The new warning may be the first time that many consumers and doctors become aware of the potential for retinal damage caused by Elmiron.

Retinal maculopathy can lead to blindness so if you are taking Elmiron, check with an opthamologist to determine if you are experiencing symptoms of maculopathy. 

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