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FDA Approves New Warning Label for Elmiron

A new 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. Click here to read updates on Elmiron safety warnings.

FDA Label Warns of “Pigmentary Maculopathy”

We have previously alerted readers about the risks of retinal disease associated with the use of Elmiron to treat interstitial cystitis, which causes pain in the bladder and pelvic regions. Elmiron is the only approved drug to treat this condition. Although Elmiron was marketed as a safe and effective medication for interstitial cystitis, the FDA has determined that a warning is necessary to caution the public that pigmentary maculopathy has been found in patients taking Elmiron. Those diagnosed with retinal disease or pigmentary maculopathy may experience blurred vision, difficulty seeing in low light, trouble reading, the appearance of dark spots, and permanent loss of vision. Pigmentary maculopathy is a progressive and irreversible disease. Evidence suggests that the condition advances despite discontinuation of the medication. Long term users are especially susceptible to this eye disease. In addition, the warning indicates that “a cumulative dose of Elmiron” presents a risk factor.

Elmiron-Associated Disease Can Lead to Serious Retinal Damage

Maculopathy is a disease of the central part of the retina which can cause blindness. Several retinal diseases that present as pigmentary maculopathy include age related macular degeneration, retinal deterioration, and pattern dystrophy. Patients who experience any of these conditions may be unaware that the disease is linked to their medication. It is important that patients be aware of the risks of Elmiron in order to receive a proper and accurate diagnosis and evaluate whether they should continue to use Elmiron for interstitial cystitis. For this reason, the new FDA label advises patients with pre-existing ophthalmological conditions and those who have been taking Elmiron for six months or more to receive comprehensive retinal exams (which include, among other tests, optical coherence tomography, fundus, and auto-fluorescence imaging).

Federal Warnings Based on Reports and Studies

The FDA warning is based on several reports of patients taking Elmiron who reported eye damage and were diagnosed with some form of retinal disease, and a new condition known as retinal maculopathy. One of the first Elmiron patients with this condition was observed by ophthalmologists at the Emory Eye Center. LK is currently representing this plaintiff, Valerie Hull, in a products liability lawsuit against the manufacturers of Elmiron.

For the complete text of the FDA warning please see:

Contact our pharmaceutical lawyers to review whether you or a family member may be entitled to financial compensation as a result of vision loss or eye complications caused by Elmiron. Levy Konigsberg LLP is currently accepting cases related to Elmiron in all 50 states. For a free confidential consultation, please call (800) 315-3806 or submit an email inquiry.


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