For some patients, yes, Elmiron does seem to cause blindness. According to research presented at the 123rd annual meeting of the American Academy of Ophthalmology in 2019, about 25% of patients with significant exposure to Elmiron show clear evidence of retinal damage.
Over time, the drug appears to cause unusual changes in the macula, or the central part of the retina. Because the macula is responsible for delivering clear central vision, victims of Elmiron may suffer difficulty reading, adjusting to dim lighting or the dark, and seeing objects up close, as well as vision dimming and areas of vision loss. In severe cases, Elmiron toxicity can lead to maculopathy, the most common cause of blindness.
What Is Elmiron?
Elmiron is the only FDA-approved medication to treat interstitial cystitis (IC), which causes severe pain in the bladder and pelvic regions. The drug works by forming a protective coating on the inner liner of the bladder, and hundreds of thousands of people, mostly women, have been exposed to Elmiron toxicity.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and the manufacturer of Elmiron, has known about the drug’s link to macular damage since at least 2018. Still, they did not include a warning about the condition until June 2020.
The Risk of Macular Damage
In a study by Kaiser Permanente, the rate of Elmiron toxicity rose with the amount of drug consumed. If detected early enough, stopping the medication may mitigate damage to the macula. Unfortunately, many patients with Elmiron toxicity are misdiagnosed with more common retinal conditions, including age-related macular degeneration and retinal dystrophy.
Patients who take Elmiron should be screened for retinal damage annually and talk to their health care provider about stopping Elmiron if they show any signs of toxicity. In later stages, toxicity can result in permanent vision loss.
Researchers do not yet know the levels at which Elmiron becomes toxic, but they have expressed growing concern to the U.S. Food and Drug Administration (FDA). Although the agency has not taken action or released any warnings, Janssen was quick to amend its label, quietly limiting its legal liability.
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