A prescription drug to treat bladder pain syndrome had the unintended effect of causing vision loss, resulting in blindness for one woman in Texas, according to MedNews. The drug, sold under the brand name Elmiron, had no warning label; studies connecting the drug with eye damage had not yet been published.
The patient started the medication in 1997, with vision changes occurring in less than two years. Her vision became blurred and her eyes had trouble adjusting to dim light. By 2002, the patient was diagnosed with maculopathy, a progressive loss of central vision. She was declared legally blind in 2010. In addition, in 2013, she was further diagnosed with pigmentary retina dystrophy.
Elmiron is prescribed for urinary tract infections, osteoarthritis and other conditions. It was approved by the FDA to treat interstitial cystitis, a chronic condition that causes pressure and pain in the bladder.
The first major study on Elmiron, published in the Journal of Urology in 2018, revealed the link between Elmiron and permanent eye damage. Additional studies by the Emory Eye Center and Kaiser Permanente corroborated the effect. Damage to the eyes included vision loss, distorted vision and difficulty reading.
In 2019, the European Medicines Agency and Health Canada each required the drug maker, Janssen, to add a warning on the label. The U.S. label was not updated until 2020. By that time, the Texas patient was diagnosed with chorioretinal degeneration. She and her husband filed a claim for damages in the U.S. District Court for the Eastern District of Pennsylvania, where Janssen is located.