Dose-Response Relationship Between Elmiron Use and Vision Problems: New Study

In the midst of growing concerns about the possibility of Elmiron use leading to permanent retinal damage and vision loss among patients, the findings of a new study suggest a “dose-response relationship” between Elmiron and severe vision problems. In other words, the greater a patient’s exposure to Elmiron (i.e. the higher the dose or the longer the treatment), the more likely the patient is to suffer vision loss side effects and the more severe the side effects are expected to be. If you or someone you love was prescribed Elmiron for interstitial cystitis and subsequently experienced difficulty reading fine print, vision distortion, difficulty adjusting to dim lighting or any other vision-related issues, contact us today to discuss your legal options. You may have grounds to file an Elmiron injury lawsuit against the drug maker in order to pursue financial compensation for your medical expenses, emotional trauma, loss of quality of life and other damages.

Elmiron May Cause Permanent Damage to Macula

Elmiron (pentosan polysulfate sodium or PPS) is an oral prescription medication approved to treat interstitial cystitis (IC), a painful bladder condition affecting between four and 12 million men and women in the United States. Elmiron has been on the market in the U.S. since 1996 and is commonly used long-term by patients experiencing chronic bladder and pelvic pain or pressure associated with interstitial cystitis, as there is no cure for the condition. Many people with IC experience an urgent and frequent need to urinate – sometimes as often as 40 to 60 times in a day in severe cases – and Elmiron is thought to help relieve these symptoms by restoring a damaged or leaky bladder surface. Unfortunately, it was recently discovered that taking Elmiron may cause patients with IC to suffer irreversible damage to the macula, which is the functional center of the retina. As a result, Elmiron users may face a greater risk of vision problems ranging from dark spots in the vision, difficulty reading or loss of vision detail to total vision loss or blindness.

Janssen Issues Elmiron Pigmentary Maculopathy Warning

The potential risk of vision loss side effects stemming from Elmiron use was not disclosed to the public until earlier this year, and Elmiron manufacturer Janssen Pharmaceuticals has been accused in a growing number of Elmiron lawsuits of withholding this information from patients and the medical community. According to a new warning added to the Elmiron label earlier this year, “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 3 years of use or longer, cases have been seen with a shorter duration of use.” The warning also states that, “While the etiology is unclear, cumulative dose appears to be a risk factor.”

Patients with Higher Elimron Exposure More Likely to Report Problems

This new study, published in the journal Retina on December 14, supports the finding that “cumulative dose appears to be a risk factor” in the development of pigmentary changes affecting the retina due to Elmiron use. In the study, researchers from Emory University in Atlanta, Georgia outline the findings of a 27-item online survey completed by 912 individuals taking Elmiron for interstitial cystitis. According to the survey results, “In this large sample of individuals with interstitial cystitis, those in the highest PPS exposure category were more likely to have difficulties reading small print and to report a prior diagnosis of macular disease.”

Possible Cause-and-Effect Relationship Between Elmiron and Vision Problems

These new study findings are indicative of what researchers refer to as a “dose-response relationship” between the use of Elmiron and the development of vision problems, which means increasing levels of exposure to the drug is associated with an increasing risk of side effects. As a general rule, demonstration of a dose-response relationship is considered strong evidence of a cause-and-effect relationship between the drug exposure and the adverse outcome in question. These findings may prove to be of great use to plaintiffs in the ongoing Elmiron litigation, in which plaintiffs claim that long-term use of the interstitial cystitis medication caused them to suffer retinal maculopathy. Unfortunately, because it took so long for Janssen to issue warnings about the Elmiron maculopathy risk, many Elmiron users diagnosed with maculopathy and other progressive eye diseases continued taking the drug for years, unaware that it may have been responsible for their vision problems.