Could Your Elmiron Medication Have Caused Your Maculopathy?

Many of the four-to-twelve million people who suffer from interstitial cystitis (IC) (a painful, chronic bladder condition) have sought relief from their symptoms by taking the prescription medication Elmiron—only to learn the drug carries some concerning side effects.

For example, one study reported that 97 percent of patients who took Elmiron for IC experienced alopecia (hair loss). The loss affected a single spot, and once affected patients stopped taking the drug, the loss was typically reversed. Other side effects of Elmiron include nausea, diarrhea, upset stomach, headache, and rash. One could describe these side effects as uncomfortable, but generally minor.

Of greater concern are the research results, including a 2018 study presented in Opthalmology, indicating that use of Elmiron for IC could damage users’ eyes and lead to vision loss. Specifically, the drug has been associated with pigmentary maculopathy, or macular degeneration. Dr. Nieraj Jain, of Emory Eye Center in Atlanta, noted that six patients who had been consuming Elmiron over the course of 15 years had experienced changes in their macula. His report raised a red flag about the possible risks of using the drug.

These findings prompted a 2019 study wherein three ophthalmologists conducted a review of Kaiser Permanente patients in North California. The doctors discovered that around 25 percent of the patients who had experienced significant exposure to Elmiron showed “definite signs of eye damage.” Furthermore, the study revealed that the rate of toxicity increased in step with the amount of Elmiron the patients had consumed (11 percent for patients who were taking 500 to 1,000 grams and 42 percent for patients who were taking 1,500 grams or more). The research further indicated that other known retinal conditions could, in fact, be artifacts of Elmiron’s toxicity. Examples of such conditions include age-related macular degeneration or pattern dystrophy.

Macular damage causes serious vision problems, as the macula is the center part of the retina, whose whole function is to sense light. The macula enables clarity and crispness in one’s vision. A damaged macula results in patients struggling to read and adjust to changes in light levels. In some cases, such damage leads to partial or complete loss of vision, blind spots, blurry vision, or trouble detecting colors or fine details.

Elmiron is a prescription oral medication (pentosan polysulfate sodium) manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals. Teva Pharmaceuticals originally developed Elmiron, but it is now made and distributed by Janssen.

Elmiron continues to be the only drug the U.S. Food and Drug Administration (FDA) has approved to treat IC, despite early clinical trials raising doubts about the drug’s efficacy.

Patients who have suffered macular degeneration after using Elmiron have filed lawsuits to recover damages for their injuries. In December 2020, a multidistrict litigation (MDL-2973) was established under Judge Brian R. Martinotti to consolidate the lawsuits in the District of New Jersey for the purpose of conducting discovery and pretrial proceedings. As of August 15, 2022, 1,740 lawsuits were pending in the MDL, according to the U.S. Judicial Panel on Multidistrict Litigation.

Our law firm has been appointed to the Plaintiffs' Executive Committee for this MDL. This means that we are directly involved in the national investigation and discovery that will hopefully result in a positive outcome for the individuals injured by this drug.