Elmiron Warnings About Difficulty Reading, Dark Adaptation and Other Vision Symptoms Added to Label in Canada, But Not in U.S.

Although makers of the interstitial cystitis drug Elmiron provided updated warnings in Canada about six months ago, recently filed lawsuits allege that users and doctors in the United States are still not being provided adequate information about the importance of monitoring for symptoms of vision loss associated with Elmiron, including difficulty reading, prolonged dark adaptation and other serious problems.

Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and has been promoted as a safe and effective treatment for interestitial cystitis or painful bladder syndrome. However, over the past year, a number of studies and case reports have established an association between side effects of Elmiron and a type of retinal disease known as pigmentary maculopathy, which may lead to irreversible vision loss.

While many urologists, ophthalmologists and other doctors in the U.S. remain unaware of the potential vision toxicity users may face, manufacturers of Elmiron issued an update to the Canadian drug monograph months ago, urging users of Elmiron to have regular ophthalmic exams for early detection of the eye problems.

According to a Health Product InfoWatch issued by the Government of Canada in October 2019, information about the risk of pigmentary maculopathy was added to the “Warnings and Precautions”, “Post-Market Adverse Drug Reactions”, and “Consumer Information” sections of the label for Canadian versions of the drug.

In addition to warning about the importance of monitoring for Elmiron vision loss symptoms, the warnings also indicate that if pigmentary maculopathy is confirmed, healthcare professionals should consider stopping the treatment. Similar recommendations have been issued by multiple eye experts in the U.S., to avoid additional damage to the retina that may be caused by Elmiron.

Macular retinopathy from Elmiron results in deterioration in the retina where vision is keenest, causing a loss of detailed vision over time. Since the retina is especially susceptible to the effects of systemic drugs like Elmiron, and has minimal ability to regenerate, lawsuits filed in the U.S. point out that updated Elmiron warnings were critical to ensure that users are carefully monitored for changes in vision. However, due to a lack of label warnings in the United States, many doctors are only now beginning to learn about the risks, and in most cases consumers remain unaware of the potential vision loss side effects.

Over the coming weeks and months, hundreds, if not thousands, of Elmiron vision loss lawsuits may be filed by former users, alleging that they may have avoided permanent retinal damage if earlier warnings had been provided about the risks associated with use of the drug and the importance of monitoring for symptoms.