Elmiron Maculopathy Problems May Occur Years After Drug is Discontinued, Case Report Warns

In a new case report published last month in Retinal Cases & Brief Reports, doctors from the Emory School of Medicine in Atlanta, Georgia indicate that vision loss problems stemming from the use of Elmiron may surface years after treatment has been discontinued. The case report describes a female patient who began to exhibit symptoms of “pentosan polysulfate maculopathy” nearly three years after she stopped taking the bladder medication. If you or someone in your family has been diagnosed with maculopathy or another serious eye condition during or after treatment with the interstitial cystitis drug Elmiron, do not hesitate to seek legal help. You may be eligible for compensation for damages like medical bills, lost wages, loss of future earning capacity and more, and a knowledgeable Elmiron vision loss attorney can guide you through the process of filing a legal claim.

Elmiron Prescribed for Interstitial Cystitis

Elmiron (pentosan polysulfate sodium, or PPS) is the only oral prescription medication FDA approved for the treatment of interstitial cystitis, a chronic condition characterized by persistent bladder pain and pressure. Elmiron is prescribed to prevent irritation of the bladder wall in patients with this condition, for which there is no cure, and the drug is often taken for years. Most of the potential side effects linked to Elmiron treatment are relatively mild, but recent reports suggest that the bladder medication may be toxic to the retina, the thin layer of tissue at the back of the eye responsible for sensing light and sending signals to the brain to enable sight.

Permanent Vision Problems Linked to Elmiron Treatment

Elmiron has been on the market in the United States for nearly 25 years and doctors have prescribed the medication to hundreds of thousands of patients during that time. Concerns about the potential for Elmiron to cause severe, potentially permanent vision problems in users first emerged in 2018, when researchers from the Emory Eye Center in Atlanta identified a “novel and possibly avoidable maculopathy associated with chronic exposure to PPS.” According to the researchers, the six adult study participants, all of whom used the drug, reported symptoms of difficulty reading and prolonged dark adaptation.

At first glance, Elmiron-related maculopathy may resemble age-related macular degeneration, a pattern dystrophy or another similar eye disease. Upon closer examination, however, doctors have found unique characteristics of what has been termed pentosan polysulfate maculopathy that distinguish it from other conditions. “[P]atients tend to suffer from significant subjective visual problems, such as trouble reading or adjusting to dim lighting, glare, and blind spots,” said Nieraj Jain, MD, of the Emory Eye Center, during an interview earlier this year. “In advanced stages, the condition can lead to profound disability, with some patients meeting the criteria for legal blindness.”

This new Elmiron case report highlights a case involving a 44-year-old patient with a 425g cumulative exposure to pentosan polysulfate sodium. According to the author, the patient presented 38 months after discontinuing Elmiron treatment, with six months of “worsening metamorphopsia and prolonged dark adaptation.” Testing and imaging showed what the author calls “characteristic features” of pentosan polysulfate maculopathy. “This case suggests that new onset clinically detectable pentosan polysulfate maculopathy may develop years after drug cessation,” the author concludes. “If corroborated, this finding has important ramifications for PPS dosing and surveillance guidelines.”

Seeking Compensation for Elmiron-Related Vision Problems

Because the potential link between Elmiron use and maculopathy was not disclosed to patients or healthcare providers before this year, many patients experiencing vision loss allegedly caused by the bladder drug have been misdiagnosed with age-related macular degeneration or a pattern dystrophy and have continued taking Elmiron. In June 2020, Elmiron maker Janssen Pharmaceuticals added new information about the possible risk of retinal pigmentary changes to the Elmiron drug label, stating that “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron.” And this new case study, as well as previous studies, suggest that these Elmiron-related vision problems may develop years after drug cessation. Based on growing evidence of side effects from Elmiron, former Elmiron users have begun filing complaints against Janssen, alleging that the drug maker failed to provide patients and healthcare providers with adequate warnings about the risk of vision loss problems.

If you or someone you love was prescribed Elmiron for interstitial cystitis and subsequently experienced vision problems like blurred vision, dark spots or difficulty adjusting to dim lighting, even if the problems manifested years after Elmiron treatment was discontinued, contact Consumer Safety Watch today. You may have grounds to file an Elmiron injury lawsuit against Janssen Pharmaceuticals and we can help put you in touch with an experienced product liability lawyer.