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Elmiron Warnings Changed to Include Risk of Eye Damage

By Burg Simpson

retinal scan

June 19, 2020   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

On June 16, 2020, significant new warnings were added to the label for Elmiron – a drug used to treat bladder pain and discomfort from a condition known as interstitial cystitis. For the first time, drug manufacturer Janssen Pharmaceuticals, Inc. warned that “[p]igmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON[.]” The warnings further provide that the reported cases of eye damage include visual symptoms such as:

  • Difficulty reading
  • Slow adjustment to low or reduced light environments
  • Blurred vision

In addition to these changes, a new Patient Leaflet will be provided to all patients filling prescriptions of Elmiron. According to this Patient Leaflet, one of the most important things to know about Elmiron is that pigment changes in the retina of the eye have been reported with long-term use of Elmiron.

These substantial changes to Elmiron’s warnings follow recent scientific articles that reported that Elmiron may be toxic to the retina. As Burg Simpson previously reported here, according to one of the recent studies, 20 percent of the participating patients with long-term use of Elmiron had signs of eye damage. In fact, Elmiron users that had previously been thought to be suffering from age-related eye conditions, such as macular degeneration, pattern dystrophy, and other retinal conditions, may be suffering from Elmiron-related vision damage.

If you used Elmiron and are experiencing worsening vision or suffer from macular degeneration, pattern dystrophy, or other vision-impairing retinal conditions, contact Burg Simpson’s Cincinnati dangerous drug attorneys today. Burg Simpson’s products liability lawyers in Cincinnati have the knowledge and resources to hold dangerous drug manufacturers accountable for the harm they have caused. They are here to help you. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation with one of our Cincinnati defective product lawyers today!

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