Breaking News! After multiple research studies and peer reviewed publications, an FDA citizens petition and patients sharing their stories, the label for ELMIRON® has now been changed in the USA to include a new warning about eye disease. Here is what the revised label says:
Retinal Pigmentary Changes
Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.
Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment.
Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON . If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment.
If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.
This is a tremendous success. We believe that it is vital that patients know the full risks vs. benefits of any medication that they are considering. For some patients, long-term Elmiron use has led to significant, potentially permanent, vision changes and/or blindness. It encourages urologists to ask patients if there is any family history with eye disease and recommends baseline retinal examinations for every patient within six months of beginning ELMIRON® treatment and on an on-going basis to determine if their retinas are being effected.
While the research suggests that patients who have used ELMIRON® 3 years or longer are more at risk of developing eye issues, the warning notes that some patients have developed symptoms after a shorter period of use. In our ICN patient survey, some patients reported eye changes during their first year of ELMIRON® use. It’s also important to note that the damage may progress after treatment has been stopped.
We would like to express our sincere gratitude to all of the opthalmologists who not only stood up, against criticism, to say that they believed ELMIRON® was linked to retinal disease but who persisted and conducted additional studies to further the case. Special thanks to:
Dr. Nieraj Jain, William Pearce and Adam Hanif – Emory Eye Institute
For publishing the first case series that established the finding of pigmentary maculopathy in patients using ELMIRON® , for writing that first Letter to the Editor to the Journal of Urology that captured our attention and for working with patients and providers across the country to develop additional research. Their groundbreaking work may help to save the eyesight of thousands of IC patients.
Dr. Robin Vora and colleagues – Kaiser Permanente Northern California
For publishing a key study demonstrating that 20% of patients actively using ELMIRON® in their study showed eye damage.
Dr. Rachel Huckfledt – Harvard Medical School
For not giving up on an IC patient who showed progressive eye damage over many years and for publishing her case study that showed that eye damage may progress long after the medication is stopped.
The IC patient community is grateful for your time, your work and advocacy on our behalf. Our work MUST continue to educate patients who are using or have used Elmiron so that they, too, can protect their eyesight.
The ICN is proud of our role in developing this research. We were the first to share the data with the IC patient community. We conducted our own research study which not only validated the Emory Eye Institutes study but showed that it may have affected significantly more patients. At the request of Dr. Phil Hanno (Stanford University), we submitted our data to the FDA in January 2019 in a request for a label revision to place this warning. What role that may have played in the final decision is unknown but we’re very proud to have contributed to this effort. If you think our work is meaningful, please consider supporting us by becoming an ICN Member or by making a donation! Your memberships directly financed this, and other, vital work on behalf of IC patients throughout the world.
- Read The Revised ELMIRON® Label Here!
- If you have used ELMIRON® and developed vision changes, we strongly suggest that you have your eyes examined immediately. Download our printable fact sheet that you can give your urologist and eye doctors.
- Four lawsuits have been filed in US District Courts in the USA on behalf of patients struggling with eye disease after using ELMIRON®. Read a Q&A from Stacy Hauer, the Attorney of Record, who filed those cases here!