Elmiron Eye Damage Comes As Surprise To Long Term Users, Due to Lack of Warnings in U.S.

Many long term users of Elmiron with eye damage are just now learning that the interstitial cystitis drug may be the cause of vision loss and other symptoms they have been experiencing for years.

Elmiron (pentosan polysulfate sodium or PPS) has been sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the United States since 1996, and is promoted as a safe and effective treatment for interestitial cystitis or painful bladder syndrome, leading most users to remain on the medication for years.

While the U.S. warning label contains no information about the link between Elmiron and eye damage, the manufacturer of the Canadian version of the medication added new information last year, urging users to seek immediate medical attention if they experience symptoms of vision loss. In addition, health regulators in Canada urge urologists prescribing Elmiron to make sure patients receive regular eye exams in Canada.

These warnings outside the U.S. were added after a series of independent studies and case reports were published over the past few years, which indicate that users may face a rare form of eye damage from Elmiron, known as pigmentary maculopathy. This may lead to irreversible vision loss, dark spots, difficulty adjusting to dark light and other problems.

Doctors in the United States are slowly learning about this link through medical literature, but the Elmiron warning label (PDF) provided for users and medical providers still contains no mention of maculopathy or vision problems.

As a result of the failure to disclose this critical safety information, a growing number of Elmiron eye damage lawsuits are now being filed in courts throughout the U.S., and a number of lawyers are advertising for potential clients, leading to a surprised reaction from long-term users who have been dealing with vision loss or other symptoms for years.

According to allegations raised in the litigation, many users suffering from pigmentary maculopathy from Elmiron have been misdiagnosed with other retinal disease, such as age-related macular degeneration, pattern dystrophy and other problems. If information and warnings had been provided about the importance of monitoring for symptoms of vision changes, users indicated that they may have avoided permanent eye damage from Elmiron.