Elmiron Drug Label Updated to Include Risk of Serious Eye Disease

Amid mounting litigation over vision loss side effects from the interstitial cystitis drug Elmiron, manufacturer Janssen Pharmaceuticals has finally added new warnings to the Elmiron drug label that include the risk of retinal maculopathy or pigmentary maculopathy, a serious eye condition that affects the retina and can cause permanent blindness. If you or someone you know is currently taking or previously took Elmiron and has since been diagnosed with maculopathy or macular degeneration, do not hesitate to contact an Elmiron maculopathy attorney for legal help. You may be entitled to financial compensation for your medical expenses, pain and suffering, and other damages, which you can pursue by filing an Elmiron injury lawsuit against Janssen Pharmaceuticals.

Elmiron and Vision Loss Side Effects

Elmiron (pentosan polysulfate) is a prescription interstitial cystitis medication that has been linked to blindness and vision changes due to a condition called pigmentary maculopathy. Warnings about the potential risk of pigmentary maculopathy side effects were added to the Elmiron drug label in Canada in October 2019, and the European Medicines Agency demanded a revised Elmiron warning label as early as June 2019, but the Elmiron label in the United States included no such warnings. Only after multiple research studies, peer reviewed publications, a Citizen’s Petition submitted to the FDA, and reports from patients adversely affected by Elmiron side effects, did Janssen finally revise the Elmiron drug label to include the risk of “retinal pigmentary changes.” The Elmiron label change was approved by the FDA on June 16, 2020.

Janssen Failed to Warn About Pigmentary Maculopathy Risk

No pharmaceutical drug is 100% safe, but when people are prescribed medications like Elmiron, they have a right to know and understand the potential health risks they could face as a result of the treatment. Unfortunately, when drug makers don’t provide adequate warnings or fail to disclose information about the possible side effects of their medications, consumers are the ones who pay the price. Elmiron has been on the market in the United States for more than 20 years and being that it is the only oral medication approved to treat interstitial cystitis, most people suffering from the painful bladder condition take the medicine for years, unaware that Elmiron use can cause vision loss and other serious, possibly permanent side effects.

What is Pigmentary Maculopathy?

Pigmentary maculopathy is a severe eye condition that affects the macula, the functional center of the retina, which is responsible for focusing central vision in the eye, controlling our ability to read, recognize faces or colors, drive a car and see objects in fine detail. Damage to the retina characteristic of pigmentary maculopathy can cause, among other side effects, blindness, blurred vision, vision distortion, loss of vision detail, difficulty reading, difficulty seeing close objects, and full or partial vision loss. A loss of vision associated with Elmiron treatment is irreversible and can progress even after the drug has been discontinued. Sadly, prior to this drug label change, the only warnings Janssen provided Elmiron users were regarding a possible risk of diarrhea, nausea, headache and hair loss.

According to the new Elmiron warning label, the retinal changes that have been linked to the interstitial cystitis drug are typically seen with long-term use (three years or more), though some patients taking Elmiron have reported suffering eye changes after a shorter period of time, even during the first year of Elmiron use. As the revised label states, “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.”

Recommendations for Patients Taking Elmiron

In order to reduce the risk of permanent vision loss due to pigmentary maculopathy, the new Elmiron label encourages healthcare professionals prescribing Elmiron to patients with interstitial cystitis to obtain a detailed ophthalmologic history prior to starting treatment. It also recommends that patients taking Elmiron undergo a retinal examination within six months of initiating treatment and then periodically throughout the course of treatment to identify any potential pigmentary changes in the retina. If you have been diagnosed with pigmentary maculopathy or macular degeneration and you believe Elmiron to be the cause, contact an experienced drug injury attorney to discuss the possibility of filing an Elmiron vision loss lawsuit against Janssen Pharmaceuticals.