Elmiron’s U.S. label updated to warn of retinal pigmentary changes

The United States label for the interstitial cystitis medication Elmiron has been changed to warn consumers about retinal pigmentary changes.

The warning warns that retinal pigmentary changes known as pigmentary maculopathy have been identified in patients who have undergone long-term use of Elmiron. The warning states that most of the cases were in people who took the drug for three years or longer, but that some cases involved a shorter usage duration.

The warning states that the etiology is unclear but that cumulative dose seems to be a risk factor.

The warning states that visual symptoms which have been reported in users of Elmiron include difficulty reading, blurred vision and slow adjustment to low or reduced light environments. It says that “the visual consequences of these pigmentary changes are not fully characterized.”

The warning advises doctors that “detailed ophthalmologic history should be obtained in all patients prior to starting treatment,” and that genetic testing should be considered for patients with a family history of hereditary pattern dystrophy.

The warning advises doctors to give patients with pre-existing ophthalmologic conditions “a comprehensive baseline retinal examination” before starting therapy, and suggests a baseline retinal examination should be performed on all patients within six months of starting treatment and then periodically while continuing treatment.

A new progressive eye disease was discovered by the Emory Eye Center in Atlanta, GA. When they looked through the histories of the six patients with the new disease, Emory discovered that all six patients had used Elmiron. Emory’s findings were later published in the Journal of Ophthalmology.

The disease and its connection with Elmiron have since been confirmed by other researchers, including researchers at Harvard Medical School, Kaiser Oakland and the IC Network. One of the most alarming findings by researchers is that Harvard researchers treated a patient whose eye disease was still getting worse six years after cessation of Elmiron treatment.

This progressive eye disease can lead to problems with reading, problems with eyesight in dim lighting, blurred vision in the center of the field of vision, dark spots in the center of the field of vision, dull colors and straight lines appearing curved.

Elmiron’s manufacturer, Janssen Pharmaceuticals, has seen multiple lawsuits filed over the drug in recent times, accusing Janssen of failing to warn consumers of the risk of eye disease associated with the drug as well as accusing Janssen of manufacturing a drug which is defective by design.


About the author

Nadrich & Cohen, LLP

Nadrich & Cohen, LLP is a California personal injury law firm with offices in Los Angeles, San Francisco, Modesto, Fresno, Tracy and Palm Desert. The firm has been representing victims of dangerous drugs since 1990 and has recovered over $350,000,000 on behalf of clients in that time.

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