Elmiron Manufacturer Updates U.S. Drug Label to Warn of Potential Eye Damage

As litigation against Janssen Pharmaceuticals, manufacturer of bladder pain drug Elmiron, mounts, the FDA has approved a change in the drug’s labeling in the U.S. The label of the drug’s “Warnings” section previously did not list any risks concerning visual impairment; however, labeling must now contain “Retinal Pigmentary Changes.” These changes may manifest as pigmentary maculopathy, a condition affects the central portion of the retina, which senses light. Pigmentary maculopathy, as well as other vision impairment symptoms, have been linked to long-term use of Elmiron. Lawsuits have been filed by Elmiron patients concerning vision damage, and claiming Janssen failed to warn patients of these risks.

You may be legally entitled to compensation if you took Elmiron and were diagnosed with a vision disorder or experienced vision loss symptoms. Contact us by submitting the form or by calling us at (866) 575-7435 for a confidential evaluation of your potential claim.