A class action lawsuit was recently filed accusing Janssen Pharmaceuticals of failing to warn consumers about the eye disease risks associated with Elmiron.
The interstitial cystitis medication Elmiron has been linked to a new eye disease which researchers named “pigmentary maculopathy.” The link between the drug and the disease has been known since at least 2018, when findings were published demonstrating the link. However, Janssen, to this date, has not added any warning regarding this disease risk to Elmiron’s United States label. The plaintiff in the lawsuit claims the defendants are negligent because they haven’t updated the drug’s label despite the link between the drug and the disease being known by the medical community since 2018.
The findings were discovered by the Emory Eye Center in Atlanta, GA. They discovered a new eye disease in six of their patients from 2015 to 2018. A review of the patients’ histories revealed that all six had taken Elmiron. This disease can cause difficulty reading, difficulty seeing in low levels of lighting, blurred vision in the center of the field of vision, dark spots in the center of the field of vision, straight lines appearing curved and duller colors.
A follow-up Emory study involved examining the data of 219 interstitial cystitis patients. 80 of the patients had been exposed to Elmiron in the past. 14 cases of pigmentary maculopathy were discovered and all 14 cases had been exposed to Elmiron, representing 17.5 percent of the patients who had been exposed to the drug. Scientists discovered that patients given Elmiron had a significantly increased risk of receiving a macular disease diagnosis at seven years in a retrospective, matched cohort study.
The disease involves excess capillaries developing or pigmented spots developing over the retina which affect vision in the center of the field of vision.
The link between the disease and Elmiron has been confirmed by other researchers, including researchers at Harvard Medical School, Kaiser Oakland and the IC Network. Alarmingly, Harvard researchers found that the disease can continue to progress in patients years after the patients stop taking the drug. Harvard treated a patient whose pigmentary maculopathy was still getting worse six years after cessation of Elmiron treatment.
Janssen added a warning about the disease risk to their Canadian Elmiron label in September 2019, and the drug’s U.S. label was updated with a similar warning on June 16.
Interstitial cystitis is a condition of the bladder which can cause chronic pain.