As a health publishing company dedicated to interstitial cystitis, it is our duty to share news which can impact you, the IC patient. Researchers at the Emory Eye Institute discovered a new eye disease, pigmentary maculopathy, is patient who have used Elmiron®. Learn more!

What is pigmentary maculopathy?

Various eye scans showing suspected macular damage from pentosan/Elmiron. Source: Emory Eye Institute

Pigmentary maculopathy is a new eye disease first described by researchers at the Emory Eye Institute in 2018. It’s called “pigment” because the color of retinal cells change and the cells stop functioning normally. Multiple research studies have since been conducted by doctors around the world who have confirmed the presence of this disease in patients taking Elmiron®. They’ve also determined that the damage can progress for years even after you stop the medication.

What examinations are necessary?

The new FDA warning label for Elmiron encourages all patients starting the medication to have a baseline retinal exam with additional annual exams to monitor the health of the retina. This is not a typical eye examination. It requires specific retinal testing, including: color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging.

Why are some urologists saying that this isn’t a “big deal.” Our Fact Sheet Can Help You Educate Them

Unfortunately, some urologists are continuing to tell patients that the eye damage is not serious because they haven’t had any of their patients report eye disease. This is a tragic misrepresentation. Hundreds of patients are now having difficulty reading and some are now legally blind. Multiple studies now confirm the presence of the disease. The FDA has required a new warning label warning clinicians and patients of the potential risk for eye damage. The FDA would not have taken this extreme step were the research not credible and supported by additional studies. Click here to download our Elmiron Eye Disease Fact Sheet that you can give to your clinicians.

Is this supported by research?

Yes, as of August 2020, 13 studies have been published that show that multiple eye researchers throughout the USA are seeing eye changes and also establish some prevalence data. Read the research studies here! 

When was the warning label released?

June 2020

What does the warning label say?

WARNINGS- 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.

Is litigation happening?

Yes, more than dozen federal lawsuits have been filed against the manufacturers of Elmiron®. Please know that each state has its own statute of limitations. If you wait to long, you may lose your right to sue. Learn more at: http://www.elmironlawsuits.com

What can I use instead of Elmiron?

Obviously, your case is unique and you should have a frank discussion with your doctor. For patients who have used the medication for years, this is a good opportunity to revisit your diagnosis, especially if you have not improved with Elmiron use or you aren’t as functional as you would like to be. Are you better? Are you worse?

While Elmiron® was the treatment of choice for 20+ years, we’ve learned a lot about IC since then including the now critical role of tight, dysfunctional muscles and previous pelvic injuries in triggering and perpetuating long-term IC symptoms. Fibroid tumors, endometriosis, tarlov cysts, pelvic congestion syndrome, chronic fungal infection, viral infection (and others) can also trigger the frequency, urgency, pressure and/or pain that we associate with IC. In many patients, the bladder is a victim of another dysfunction in the pelvis. Thus, these patients benefit from other therapies (such as pelvic floor physical therapy) rather than a bladder coating therapy. Learn about IC subtypes here.

Elmiron® works primarily for patients who have a damaged bladder wall (i.e. from chemical injury, estrogen atrophy etc.). If you have found Elmiron® helpful in reducing your symptoms, your first option is bladder instillations that would provide a similar coating effect (i.e. heparin, Elmiron®, lidocaine, IaAluRil®). This allows 100% of the medication to reach the bladder with less systemic absorption that could affect the eyes. But, this will require multiple visits to your urologist or you may have to be taught to do them at home.

Because there is no other FDA approved oral medication for IC that provides a similar effect, patients usually turn to chondroitin based supplements which are believed to have a similar coating effect. Because Elmiron has become so expensive, many patients over the years have made this transition successfully. OTC supplements have been used for 20 years now and are suggested in the American Urology Association IC/BPS guides (Step One Treatment Option – Guideline Statement 11) as well as by many of the top IC clinicians in the USA.

Read our Elmiron® transition guide here