Elmiron: The Controversy

James Parker
August 4, 2021

The drug Elmiron is manufactured by Janssen Pharmaceuticals and employed as the primary treatment for interstitial cystitis (IC). Despite its status as the only FDA-approved oral medication for IC, Elmiron has courted controversy as increasing evidence mounts that long-term use of the drug can lead to pigmentary maculopathy, a visual condition that can permanently damage the victim’s sight. 

Elmiron was initially approved on the backs of two clinical trials. The first trial involved 151 patients who took Elmiron for three months. The second study was not blinded and although it was initially designed for 2499 patients, only 24% of patients (598) made it to the one year mark of use. 

In addition to the flaws in the initial approval studies, later research has shown that the signs of pigmentary maculopathy don’t begin to show until up to a decade of Elmiron buildup in the body. While it may make sense to have a shorter-term trial for a treatment drug that cures the condition, Elmiron is not a treatment drug. 

Elmiron does not cure IC, it only treats the pain caused by the disease. Jannsen could be expected to conduct long-term studies with the understanding that their product would be taken for potentially an entire lifetime to manage the symptoms of IC. Instead, Janssen updated its labeling in 2020 to include warnings of maculopathy. This change to their labeling came two years after research began to surface about Elmiron’s connection to pigmentary maculopathy and 24 years after Elmiron’s approval in 1996.

If you or a loved one have developed pigmentary maculopathy after taking Elmiron, you are not alone. Thousands of victims are raising their voices to demand justice for the damage that was done to them by hidden side effects that Janssen failed to warn about. If you want to join these voices, you will need a Mass Torts attorney.

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