Langston & Lott, PLLC
Elmiron Lawsuit

What is Elmiron®?

Elmiron® is a drug commonly prescribed for bladder pain. According to recent research, Elmiron® can damage people’s eyes and even cause vision loss. Elmiron® has been sold since the mid-1990s to hundreds of thousands of people who suffer from a particular urinary disorder called interstitial cystitis, which affects more than 12 million Americans, more than 90% of whom are women. The earliest clinical trials for Elmiron® from the 1990s not only revealed that the drug didn’t work very well but also a host of adverse events including ophthalmologic problems. Now, more than two decades later, multiple studies have revealed a new eye disease, “retinal maculopathy”, in numerous patients taking Elmiron®. Several lawsuits have been filed against Janssen, the manufacturer of Elmiron®, alleging Janssen failed to warn users that Elmiron® could cause vision loss and other eye problems.

The Studies

The line of studies identifying Elmiron®’s toxicity began between 2015 and 2017 when doctors from the Emory Eye Center in Atlanta, noticed a trend among six patients with abnormal damage to the macula region of their eyes. They were all diagnosed with pigmentary maculopathy, a condition causing severe vision impairment, including blurred vision, extreme sensitivity to light and dark, and difficulty transitioning from natural light to indoors. Blindness may also occur as the disease progresses. All six patients were similarly found to be long-term users of Elmiron®. As a result, the Emory Eye Center published a preliminary report in 2018 suggesting that Elmiron® was toxic to the retinal tissue of the human eye, specifically, causing injury to the retinal pigment epithelium, a layer of cells that nourishes the retina.

Additional studies published in 2019 found similar results. Researchers found greater toxicity in patients who took the drug for longer periods of time. A cohort study in the British Journal of Ophthalmology found that users taking the drug for seven years significantly increased their odds for macular disease compared with those taking it for five years.

These warnings prompted a more detailed study into the risks of taking Elmiron® and its toxicity to the eyes by the American Academy of Ophthalmology (AAO). Its research revealed that patients taking Elmiron® showed clear signs of toxicity. About 25% of patients who used Elmiron long-term displayed signs of maculopathy or significant eye damage. The study revealed that the rate of toxicity was compounded by the amount of the drug consumed. The AAO study team suggested that the rate of toxicity rose with the amount of the drug consumed, from 11% of those taking 500 to 1,000 grams to 42% of those taking 1,500 grams or more.

The same doctors published a January 2020 follow-up study of 117 patients that solidified their conclusions that there is “strong support to the growing body of evidence that links long-term Elmiron® use to the potential development of a toxic maculopathy.” The AAO studies indicate that if caught in its early stages, the damage to the retina may cease after taking medication. In later stages, after prolonged use of the drug, the disease can lead to permanent vision loss. This research found that symptoms associated with Elmiron® damage to the eyes include:

• Areas of vision loss in the field of vision
• Difficulty adjusting to dim lighting or darkness
• Difficulty reading
• Difficulty seeing objects at close range
• Vision dimming

The Warnings

For more than a decade, Janssen marketed Elmiron® as a safe and effective treatment for interstitial cystitis. When first introduced, and in the ensuing years, the label and prescribing information accompanying the drug contained no warnings. Elmiron® was viewed as relatively safe with few significant side effects. Canada announced in October 2019 that pigmentary maculopathy would be added to the warnings and precautions on the Elmiron® label. Janssen updated the Elmiron® label in other countries, but it was not until June 2020, after litigation had begun, that the company changed the label for Elmiron® products sold in the U.S. to reflect the risk of vision loss. Under pressure from a now mounting number of Elmiron® lawsuits, the FDA approved Janssen’s request to change the Elmiron® warnings on the label to include the risk of retinal pigmentary “changes.” Janssen now admits these permanent vision injuries can occur with both long-term and short-term use of the drug. Unfortunately, the label changes came too late to save many patients who have already suffered permanent and irreversible eye damage.