The U.S. Food and Drug Administration approved a warning label change for Janssen Pharmaceuticals’ bladder pain and interstitial cystitis drug Elmiron on June 16, 2020. The new label cautions that “pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON. Although most of these cases occurred after three years of use or longer, cases have been seen with a shorter duration of use.”
The FDA advises doctors to:
- “Use caution” with patients that display retinal pigment changes.
- Watch out for a family history of hereditary pattern dystrophy.
- Take a detailed ophthalmologic history.
- Take a baseline retinal exam within six months of initiating treatment as well as periodically while taking the drug.
While these changes are significant, many American patients are wondering why the warnings were lacking when they have been on Elmiron packaging in Canada since October 2019 and European countries since June 2019. Lawsuits alleging Elmiron eye damage have already been filed, and many more are expected to follow in the coming months and years. If you or a loved one have experienced eye damage or vision loss while taking Elmiron or shortly thereafter, you may be eligible for substantial compensation to cover medical bills, loss of quality of life, and more. Showard Law Firm is currently reviewing these cases, and during a free consultation, we can advise you of your legal rights.
Signs You May Have Eye Damage from Elmiron
Reported visual symptoms of Elmiron eye damage include:
- Difficulty reading
- Slow adjustment to low or reduced light environments
- Loss of night vision
- Blurred vision
- Image distortion
- A blind spot in the center of the vision field
- Inability to focus
- Retinal color changes
Patients experiencing vision problems while taking Elmiron should receive follow-up retinal examinations and weigh the risks/benefits of discontinuing treatment. Even after cessation of treatment, the vision changes may persist irreversibly.
Testing Elmiron Users for Pigmentary Changes in the Retina
An eye doctor may perform the following tests to determine whether a patient has retinal maculopathy:
- The Amsler grid test – Central vision clarity is determined by showing patients a grid. A patient with normal vision would see straight lines, while someone with retinal maculopathy would see lines that appear faded, broken, or distorted. The location of the distortion can help doctors pinpoint the extent of retinal damage.
- Optical coherence tomography (OCT) – Precise images of the retina are captured to assess epiretinal membranes, macular holes, macular swelling (edema), and age-related macular degeneration.
- Fundus autofluorescence (FAF) – Advancement of retinal diseases, particularly in retinal pigment, is assessed using a non-invasive camera that can take photos of the back of the eye without contrast dye.
Sometimes fluorescein angiography, indocyanine green angiography, ultrasound, CT, and MRI are ordered.
Studies Linking Elmiron and Vision Loss
Elmiron has been linked with vision loss in a number of studies:
- November 2018: Emory Eye Center published a case study of six patients with pigmentary maculopathy of unknown cause from May 2015 to October 2017. No genetic or pathological abnormalities were identified, but the common thread was that all patients had taken Elmiron long-term to treat interstitial cystitis.
- April 2019: Emory Eye Center published a study in the Journal of Urology of 10 patients who developed pigmentary maculopathy after taking Elmiron for interstitial cystitis. Another 156 patients in their clinic suffered from interstitial cystitis, but did not have pigmentary maculopathy.
- October 2019: Kaiser Permanente found that 24% of 140 patients who had taken Elmiron for at least five years suffered eye damage. Furthermore, the rate of toxicity increased from 11% among those taking 500 to 1,000 grams to 42% among those taking 1,500 grams or more.
- October 2019: Harvard Medical School researchers published a case study about a patient whose Elmiron-related pigmentary maculopathy worsened six years after cessation of treatment.
- November 2019: Emory Eye Center researchers released the results of a matched, cohort studyof thousands of Elmiron users compared to controls, which determined that Elmiron users had a significantly higher risk of pigmentary maculopathy after seven years.
Scientists aren’t exactly sure how Elmiron is causing eye damage, but Alam Hallan, the director of the pharmacy at Guelph General Hospital in Canada, posits that the retinal cells contain chemicals that interact with the drug, resulting in cell death.
Drug Manufacturers Owe a Duty of Care
Drug manufacturers owe a standard duty of care to adequately test and safely develop their medications before releasing them to market. If any risk factors arise – either in their own research or the published research of others, they are required by law to indicate these risk factors on the warning label of the drug.
Prior to July 2020, Elmiron labels in the U.S. did not contain any indication of potential vision loss or damage. However, considering these warnings were already included on labels in Canada and Europe, it was clear the company knew of possible risks and simply chose not to inform American patients and doctors, presumably to avoid a drop in drug sales.
Patients who have filed lawsuits say they would have considered other treatments had they known there was a risk of permanent vision impairment. At the very least, doctors should have been warned so they could assess patients based on family history and perform tests to limit the risk of adverse events.
Learn More About Filing an Elmiron Lawsuit
Elmiron lawsuit plaintiffs seek to hold Janssen Pharmaceuticals liable for the failure to warn of known risks associated with their product. A personal injury lawsuit filed in civil court can result in compensation for medical expenses, lost wages from work, the cost of future disability, and an estimated amount of pain and suffering. If you believe that yourself or a loved one may have sustained eye damage from Elmiron, we invite you to contact Showard Law Firm for a free consultation to explore your legal options.