Maculopathy Lawsuit Filed Over Elmiron Side Effects

A Florida woman has filed a product liability lawsuit after experiencing maculopathy from Elmiron, indicating that the makers of the interstitial cystitis drug failed to warn users about risk that users may suffer retinal damage and be left with permanent vision side effects.

The complaint (PDF) was filed by Robin Hamblett in the U.S. District Court for the Southern District of Florida on July 29, naming Teva Pharmaceuticals, Ivax, LLC, Bayer Healthcare Pharmaceuticals , Janssen Pharmaceuticals, and its parent company, Johnson & Johnson, as defendants.

Elmiron (pentosan polysulfate sodium or PPS) is the only approved drug treatment for interstitial cystitis or “painful bladder syndrome”, and has been marketed as safe and effective since 1996. Although concerns existed for years among vision specialists about the risk of retina damage, Elmiron vision warnings were not added to the drug label in the U.S. until June 2020.

The label update came after a series of independent studies and case reports published in recent years highlighted cases involving visual injury and pigmentary changes in the retina among long-term users of Elmiron. The drug has been linked to reports in which users to experienced difficulty adjusting in dark light, problems reading, centralized dark spots and other complications, yet information about the risk of pigmentary maculpathy was withheld from the drug warning label for years.

According to this latest lawsuit, Hamblett was diagnosed with interstitial cystitis and prescribed Elmiron in 2010. She took the drug until 2020.

“During the relevant time periods, Plaintiff and her physicians were given no warning and had no knowledge of the serious risk of retinal damage and vision loss posed by Elmiron,” Hamblett’s lawsuit states. “As a result of her exposure to Elmiron, Plaintiff now suffers from maculopathy, and blurry and distorted vision.”

The lawsuit notes that Elmiron has poor oral bioavailability and absorption, which requires users to take long-term high doses, which causes it to accumulate in the body, increasing toxicity over time.

“Users must ingest Elmiron for at least 3 to 6 months – and often longer – to achieve any benefit,” the lawsuit states. “Populations of patients receiving extended treatment (>2 years) showed no further improvement or worsening of symptoms, yet users often continue the drug for years.”

Since most ophthalmologists were previously unaware of the Elmiron maculopathy risks associated with the bladder drug, a growing number of long-term Elmiron users are just now learning that they may have been previously misdiagnosed with other retinal diseases, such as macular degeneration, pattern dystrophy and other problems, which were actually caused by the toxic effects of the drug on the eyes.

As Elmiron lawyers continue to review and file claims in the coming months and years, it is expected that hundreds of similar complaints may be brought in state and federal courts nationwide.