Elmiron (pronounced el-muh-ron) is a drug used to treat a rare condition called Interstitial Cystitis. Few drugs treat this condition. However, long-term use of Elmiron has been linked to vision loss and retinal maculopathy.
What is Interstitial Cystitis?
Interstitial cystitis (IC) is a chronic condition typically (but not always) found in women. It causes bladder pressure, bladder pain, and sometimes pelvic pain. There is currently no known cure for the condition, and the pain may negatively affect a person’s day-to-day life. Elmiron is one of the only drugs developed to treat IC.
What’s the Problem With Elmiron?
In 1985, Elmiron was granted an FDA orphan drug designation, which is defined as “those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.” However, in 1993, the FDA issued its first non-approval letter for Elmiron, citing issues with both clinical trial investigators and clinical trial results. In 1994, the FDA issued its second non-approval letter citing insufficient clinical trial evidence to establish efficiency. Upon reviewing the clinical trial results, the FDA issued a response that the new drug application Elmiron (NDA) awas NOT approvable.
Elmiron Linked to Maculopathy
In 2018, the Emory Eye Center announced the discovery of a new disease called Retinal Maculopathy, which causes significant vision problems. In this study of 6 patients diagnosed with this new disease, all patients were women and each had taken Elmiron for IC. A second study conducted by the Emory Eye Center also linked Elmiron to maculopathy and recommended patience undergo comprehensive ophthalmic examinations. Further, an October 2019 Kaiser Permanente study identified 24% of its 91 subjects who took Elmiron for at least 5 years had retinal pigmentary maculopathy and vision symptoms. Additional subsequent studies from various health organizations also show a link between Elmiron and maculopathy.
Common side effects initially linked to Elmiron and disclosed on the label include hair loss, upset stomach, nausea, dizziness, abnormal liver function, and bruising, among others. However, vision loss, vision impairment, and changes in retinal pigment are NOT included on this list.
The Ruth Law Team is currently accepting new clients who have taken Elmiron and experienced issues with vision. There have not yet been any verdicts or settlements related to Elmiron cases, however, we are working hard on behalf of our clients impacted by defective drugs and products.
If you took Elmiron and were diagnosed with maculopathy or other vision condition, contact The Ruth Law Team at 888-783-8378. We offer a free consultation for all callers. You could be eligible for compensation for medical expenses, income loss, pain and suffering, future medical care, and more.