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

Harvey Kirk

By Harvey Kirk
Posted July 6, 2020


In recent years, there have been a growing number of independent studies and case reports that highlight the link between Elmiron and eye problems, leading to lawsuits brought on behalf of former users of the bladder drug who have been left with maculopathy, macular degeneration and other vision loss.

Although it appears that the makers of the institial cystitis drug knew or should have known about the toxic side effects of Elmiron on the vision, no warnings or information about the potential risk was included on the drug label until last month, causing many long-term users to experience eye problems that could have been avoided.

According to the latest version of the Elmiron warning label (PDF), which was updated without any apparent press release or statement by the drug makers on June 16, information about the risk of “retinal pigmentary changes” was included for the first time.

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As a result of the failure to warn about these eye problems earlier, financial compensation may be available for long-term users of the drug who have been diagnosed with maculopathy, macular degeneration or experienced any of the following symptoms:

  • 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;

The product liability lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations for individuals throughout the United States, to help determine what legal options may be available. To review a potential claim for yourself or a loved one, request a free consultation and claim evaluation.

Elmiron Vision Loss Warnings

Elmiron (pentosan polysulfate sodion; PPS) was first approved for sale in the U.S. nearly twenty five years ago, and the manufacturers knew or should have known that the medication was toxic for the eyes and retina, yet Johnson & Johnson and its Janssen subsidiary placed the desire for profits before consumer safety by withholding adequate warnings for decades.

Although the U.S. Elmiron warning label contained no information about the risk of eye damage until last month, Canadian drug regulators announced that similar warnings would be added in that country in October 2019, but users and doctors in the United States were still not told about the risk.

According to the recent warning label update, the drug makers now disclose that “pigmentary changes in the retina” have been identified with long-term user of Elmiron, acknowledging that cumulative dose appears to be a risk factor.

“Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON,” the label warning states. “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.”

The drug label now urges doctors to obtain a detailed ophthalmologic history from all patients before starting Elmiron, and indicates that a comprehensive eye exam should be conducted for some patients before starting treatment, and within six months of initiating treatment with Elmiron for all patients.

Doctors are also advised to continue with periodic baseline retinal examinations while continuing treatment, yet thousands of current and former users have been on Elmiron for years without any eye exam by an ophthalmologist or retina specialist.

Unfortunately, for long-term users of the Elmiron the eye damage may already be irreversible, as the new warning label also acknowledges that the pigmentary changes in the retina may be permanent and that vision changes may continue to progress and worsen even after stopping treatment with Elmiron.

Elmiron Maculopathy and Macular Degeneration Lawyers

If you, a loved on or family member has been diagnosed with maculopathy after long-term Elmiron use, request a free consultation and claim evaluation. All claims are handled on a contingency fee basis, meaning there are never any out-of-pocket expenses and no fees unless an Elmiron settlement or judgment is obtained.


2 Comments • Add Your Comments

  • Dwain says:

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    Posted on July 9, 2020 at 7:24 pm

  • Albert says:

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    Posted on January 11, 2021 at 5:20 am

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