Johnson & Johnson and its Janssen subsidiary face a class action lawsuit over the Elmiron side effects, which indicates that the makers of the controversial interstitial cystitis drug should be required to pay medical monitoring and vision exams for users, who now face an increased risk of retinal damage and vision loss.

The complaint (PDF) was filed by Mary Lee Allen in the U.S. District Court for the Eastern District of Pennsylvania on May 6, seeking class action status to pursue damages for herself and other former users who now require vision monitoring and diagnostic services that could have been avoided.

Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and has been promoted as a safe and effective treatment for interstitial cystitis. However, a growing number of studies and case reports now suggested users may develop a type of retinal disease known as pigmentary maculopathy, which can leave them with severe difficulty adjusting in dark light, difficulty reading, dark spots and other problems.

“Throughout the time Defendants marketed Elmiron, Defendants withheld material adverse events from the public, medical community, and the FDA,” Allen states in her complaint. “Defendants failed to disclose the serious link between Elmiron use and significant visual damage, including pigmentary maculopathy. Ultimately, tens of thousands of patients, including Plaintiff, were placed at risk and harmed as a result of this misleading conduct.”

Allen indicates she has taken Elmiron for the treatment of interstitial cystitis since 2009, and her long-term use of the drug now places her at an increased risk of severe visual injuries, including vision loss, retinal macular dystrophy, pigmentary maculopathy and atypical macular degeneration.

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 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.

Allen’s class action joins a growing number of other Elmiron lawsuits now being pursued in courts nationwide, each raising similar allegations that users could have avoided irreversible eye damage if warnings had been provided by the drug makers. However, while most claims filed previously have involved plaintiffs who suffered actual vision loss, this lawsuit seeks compensation and medical monitoring fees for all those who have not suffered retinal damage but now are at an increased risk of such injuries.

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.

Tags: Class Action Lawsuit, Elmiron, Interstitial Cystitis, Johnson & Johnson, Pigmentary Maculopathy, Retinal Injury, Vision Loss