Elmiron Maculopathy Lawsuit Alleges Manufacturer Failed to Properly Test Bladder Drug

A new Elmiron lawsuit filed by a Minnesota woman diagnosed with a unique eye disorder known as pigmentary maculopathy claims that the makers of Elmiron failed to properly evaluate the possible side effects of the bladder pain medication before making it available to consumers. The Elmiron injury case was filed in the U.S. District Court for the District of New Jersey on December 3, 2021, by Gloria Granberg and her husband, Mike Granberg, and it joins a growing number of lawsuits brought against Janssen Pharmaceuticals for eye injuries allegedly caused by Elmiron toxicity. If you or someone you know took Elmiron for interstitial cystitis and subsequently developed pigmentary maculopathy or another progressive eye disorder that may have been misdiagnosed as age-related macular degeneration, contact Consumer Safety Watch today.

Irreversible Retinal Toxicity from Elmiron Treatment

Elmiron (pentosan polysulfate sodium) is a medication commonly prescribed for the treatment of interstitial cystitis (IC), or bladder pain syndrome, a chronic bladder condition that can cause severe pain and urinary urgency and frequency. The FDA approved Elmiron in 1996, and it is currently the only oral medication approved by the FDA specifically for the purpose of treating IC. There is no cure for IC and many people prescribed Elmiron for IC end up taking it long-term at high doses, due the drug’s poor oral bioavailability and absorption. According to the Granbergs’ lawsuit, “Typical users take 100mg doses, 3 times per day, because only about 6% of the drug is absorbed to the epithelial cells of the bladder; the majority of the drug is excreted.” However, the lawsuit states, “the drug is also absorbed into retinal epithelial cells, which can result in retinal toxicity.”

Elmiron Use Linked to Pigmentary Maculopathy

The potential for Elmiron to cause retinal toxicity has emerged as a significant cause for concern considering recent scientific evidence linking long-term Elmiron use to a novel eye disorder known as pentosan polysulfate sodium (PPS) maculopathy. Patients who present with this unique type of maculopathy have experienced pigmentary changes to the retina that are irreversible and that can lead to vision loss, blurred vision, difficulty adjusting to dim lighting, or possibly even blindness. According to the Granbergs’ lawsuit, the makers of Elmiron have admitted that “the mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known” and have failed to conduct proper testing to determine exactly how Elmiron works and what adverse effects the treatment may cause for users.

The Granbergs state in their lawsuit that Gloria Granberg was prescribed Elmiron by her physician and took the medication for approximately 18 years, from 2001 to 2019. She was never warned about the potential for Elmiron treatment to cause pigmentary maculopathy and had no knowledge of the serious risk of permanent eye damage she could suffer while taking the medication. As a result of her exposure to Elmiron, the lawsuit claims, Gloria suffered injuries to both eyes. Had Gloria Granberg and other long-term Elmiron users been adequately informed about scientific studies and reports of serious eye and vision problems in patients taking Elmiron, they may have avoided suffering permanent damage to their vision.

Contact an Elmiron Injury Attorney for Legal Help

“Despite study after study providing clear evidence of the dangers of PPS, Defendants failed to adequately investigate the threat that PPS poses to patients’ eyes and vision or warn patients of the risk that they would suffer retinal injury and vision impairment,” the Granbergs’ lawsuit states. “[Elmiron’s] design defects render [the drug] more dangerous than other drugs and treatment options designed to treat IC and cause an unreasonable increased risk of injury, including but not limited to permanent vision and retinal injuries.” If you were prescribed Elmiron for interstitial cystitis and you have since been diagnosed with pigmentary maculopathy or another serious eye disorder, do not hesitate to contact an Elmiron injury attorney to discuss your legal options. You may have grounds to file a claim against the drug manufacturer in order to pursue financial compensation for your injuries.