The drug is manufactured by Janssen (a Johnson & Johnson subsidiary) and other manufacturers. PPS was sanctioned in 1996 as the only FDA-approved oral medication for treating IC. Because it was considered completely safe upon entering the market, it was packaged without any warnings.
In 2019, however, at the 123rd Annual Meeting of the American Academy of Ophthalmology, a handful of distinguished ophthalmologists from separate major U.S. research institutions, reported strong evidence of a link between the use of Elmiron in cystitis patients and resulting maculopathy (macular degeneration), according to a University of TX Southwestern Medical Center report released October 17, 2022.
At first, few doctors believed that a drug to treat bladder irritation could cause serious vision problems or even subtle blindness over time, but the medical link was firmly established. In June 2020, Janssen revised its Elmiron label, specifically warning that a type of retinal damage called pigmentary maculopathy (macular degeneration) had been identified with use of the drug.
But even with the added warning for “retinal pigmentary change,” Janssen has not acknowledged claims of eye damage linked to Elmiron, nor indicated that it will issue a recall in response to increased cases of alarming eye conditions.