Pigmentary Maculopathy and Severe Visual Injury Caused By Elmiron, Lawsuit Alleges

The makers of Elmiron face a product liability lawsuit filed by a woman whose visual injury and pigmentary maculopathy diagnosis was one of the first cases of eye damage linked to the interstitial cystitis drug identified by independent researchers.

Valerie Hull filed a complaint in New Jersey Superior Court on June 9, according to a press release issued by her lawyers.

The case joins a growing number of similar Elmiron lawsuits being pursued against Johnson & Johnson, it’s Janssen subsidiary, and Teva Pharmaceuticals, over failure to warn about side effects linked to the drug in a series of case reports and studies published over the past year.

Elmiron (pentosan polysulfate sodium or PPS) has been widely used as a treatment for interstitial cystitis or painful bladder syndrome since 1996, but concerns have only recently emerged about potentially toxic side effects on the vision, with independent researchers linking long-term use of the drug to reports of visual injury and pigment changes in the eye. This has resulted in complaints that users experience difficulty adjusting in dark light, problems reading, centralized dark spots and other complications associated with a unique type of retinal disease known as pigmentary maculopathy.

According to the press release, Hull, from South Carolina, took the interstitial cystitis drug from 2001 until 2018, and participated in a study published in 2018 by the Emory Eye Center. After suffering serious vision problems, including vision loss, night vision loss and changes in eye color pigment, Hull became known as “patient zero” for researchers linking Elmiron side effects to pigmentary maculopathy.

She was a patient of Dr. Nieraj Jain at the Emory Eye Center, and she and five other patients became the basis for Dr. Jain’s study, which was the first to establish a link between Elmiron and eye injuries.

According to the lawsuit, the manufacturers knew about the potential eye problems for decades, but failed to provide adequate warning to patients or the medical community about the risk of Elmiron vision loss.

Although users and doctors in the United States have not been warned about these problems, the manufacturers did update the warning label in Canada last year, indicating that users should seek immediate medical attention if they experience symptoms of vision loss, and urologists were urged to make sure users of Elmiron received regular eye exams with an ophthalmologist.

Since most ophthalmologists were previously unaware of the effects of Elmiron on the eyes, many individuals have been misdiagnosed with other retinal diseases, such as age-related macular degeneration, pattern dystrophy and other problems.