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In June 2020, Janssen Pharmaceuticals, which manufactures the interstitial cystitis (IC) drug Elmiron, updated the warning label on the medication, alerting patients and doctors of the potential risk of vision damage. Unfortunately, there is evidence that suggests that the drug manufacturer knew or should have known that the risk had existed for years before that.

The warning, together with the publication of studies linking the drug to eye damage, led many patients diagnosed with vision problems to seek compensation from the manufacturer.

Up until recently, it was thought that stopping the medication would stop the corresponding damage to the eyes, but according to a newly released case study, that may not be the case.

Case Study Suggests Maculopathy Can Develop Years After Stopping Elmiron

According to doctors from the Emory University School of Medicine in Atlanta, Georgia, a 44-year-old female was evaluated three years after she had stopped taking Elmiron complaining of vision problems. Upon examination, the doctors found that she had characteristics of “pentosan polysulfate maculopathy,” or Elmiron-induced macular damage.

The woman showed no signs of this condition 25 months before this, indicating that it had developed well after she stopped taking Elmiron. “This case suggests that new-onset clinically detectable pentosan polysulfate maculopathy may develop years after drug cessation,” the researchers wrote.

In 2018, researchers first alerted the public to the fact that Elmiron may cause vision damage back. Dr. Neiraj Jain and colleagues wrote a letter to the editor of the Journal of Urology alerting readers to a new condition they were seeing among their patients taking Elmiron. Symptoms included difficulty reading and adapting to areas of dim light, along with subtle hyperpigmentations (spots) on their retinas.

In a later study evaluating patients at the Emory Eye Center with IC or painful bladder, which is the condition that Elmiron is approved to treat.  Over a four year period, there were 219 patients with IC, 80 of whom had taken Elmiron. Fourteen of them were found to have the same type of maculopathy.

Elmiron Manufacturer Kept Users in the Dark

Elmiron was first FDA-approved for the U.S. market in 1996. It is the only drug specifically approved for the treatment of IC. Patients must stay on the medication to receive the benefits. That means thousands of patients have taken the drug for years, often decades, without realizing its potential effects on their vision.

Long-term use appears to be dangerous, as according to a 2019 study, patients taking pentosan for seven years or longer were at an increased risk of having maculopathy. Scientists at Kaiser Permanente also reported that of the 140 of their patients who had taken Elmiron for a minimum of 5 years, 22 (24 percent) showed eye damage. The greater the quantity of Elmiron taken, the greater the damage.

Despite these and other studies showing the dangers of Elmiron, manufacturer Janssen Pharmaceuticals refused to alert the public until they came under pressure from regulatory agencies. The European Medicines Agency (EMA) demanded changes to the Elmiron label in the summer of 2019, and Health Canada required similar changes in October 2019. Yet the company continued to leave U.S. users in the dark until, under additional pressure from the International Cystitis Network (ICN), they finally changed the label in June 2020.

Now the company faces about 100 claims filed by plaintiffs who used the drug and then suffered from vision damage. It is expected that the number of Elmiron lawsuits will continue to increase in the coming months.

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