Elmiron Eye Problems May Have Been Avoided If Earlier Warnings About Maculopathy and Macular Degeneration Had Been Provided

By Harvey Kirk
Posted July 6, 2020

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April 2026 Update: Saiontz & Kirk is no longer filing new Elmiron lawsuits. This page is maintained for informational and historical purposes only.

In prior years, a number of independent studies and case reports highlighted a potential link between Elmiron and eye problems, leading to lawsuits filed on behalf of former users of the bladder drug who alleged they developed maculopathy, macular degeneration and other vision injuries.

Elmiron lawsuits alleged that the makers of the interstitial cystitis drug knew or should have known about the potential vision risks before warnings were added to the U.S. drug label. Plaintiffs claimed that earlier warnings may have allowed long-term users and doctors to monitor for retinal changes sooner or reconsider continued use of the drug.

According to an updated version of the Elmiron warning label, information about the risk of “retinal pigmentary changes” was added in June 2020.

As a result of allegations that earlier warnings should have been provided, Elmiron lawsuits were previously filed by long-term users who were diagnosed with maculopathy, macular degeneration or experienced symptoms such as:

• Progressive vision loss or deterioration of the eyes;
• Blurry vision or distorted vision;
• Difficulty reading;
• Prolonged dark adaption or problems seeing at night;
• Loss of detailed vision;
• Darkening vision;

Saiontz & Kirk previously reviewed Elmiron lawsuits for individuals throughout the United States. The firm is no longer filing new Elmiron lawsuits, and this information is provided for historical purposes only.

Elmiron Vision Loss Warnings

Elmiron, also known as pentosan polysulfate sodium or PPS, was first approved for sale in the United States nearly 25 years before the June 2020 label update. Elmiron lawsuits alleged that Johnson & Johnson and its Janssen subsidiary knew or should have known about the potential risk of retinal injuries, but failed to provide adequate warnings for long-term users and doctors.

Although the U.S. Elmiron warning label did not include information about the risk of retinal pigmentary changes until June 2020, Canadian drug regulators had announced in October 2019 that similar warnings would be added in Canada.

According to the U.S. label update, the drug makers disclosed that “pigmentary changes in the retina” had been identified with long-term use of Elmiron, and that cumulative dose appeared to be a risk factor.

The updated drug label indicated that pigmentary changes in the retina, reported in medical literature as pigmentary maculopathy, had been identified with long-term use of Elmiron. The label also stated that most cases occurred after three years of use or longer, although some cases had been seen with a shorter duration of use.

The label update advised doctors to obtain a detailed ophthalmologic history from patients before starting Elmiron. It also indicated that a comprehensive eye exam should be conducted for some patients before starting treatment, and within six months of starting treatment for all patients.

Doctors were also advised to continue periodic retinal examinations while patients remained on Elmiron. Lawsuits alleged that many current and former users had taken the drug for years before these warnings were added.

The updated warning label also acknowledged that pigmentary changes in the retina may be permanent and that vision changes may continue to progress even after stopping treatment with Elmiron.

Elmiron Maculopathy and Macular Degeneration Lawyers

Elmiron maculopathy and macular degeneration lawsuits were previously filed by individuals who alleged they developed retinal injuries or vision problems after long-term use of the drug.

These lawsuits claimed that earlier warnings may have allowed patients and doctors to detect retinal changes sooner, obtain monitoring by an ophthalmologist or retina specialist, or avoid continued exposure to Elmiron.

Saiontz & Kirk is no longer filing new Elmiron lawsuits. This page is maintained for informational and historical purposes only.