Elmiron Pigmentary Maculopathy Warning on Canadian Label. Why Not United States?

Published on April 21, 2020 by Sandy Liebhard

The manufacturers of Elmiron (pentosan polysulfate sodium)  recently updated the drug’s Canadian label to warn of the potential for pigmentary maculopathy, a retinal disorder that can result in permanent vision loss.

Yet the labeling for Elmiron sold in the United States continues to lack any such warning.

Elmiron and Pigmentary Maculopathy

Elmiron is the only drug approved by the U.S. Food & Drug Administration (FDA) to relieve bladder pain and discomfort associated with interstitial cystitis. Since coming to market in 1996, however, the FDA’s Adverse Event Reporting System has received at least 100 reports of eye disorders related to the use of Elmiron, including 8 cases considered serious and 22 that mentioned various forms of maculopathy.

In recent months, a growing body of research has also pointed to a link between Elmiron and pigmentary maculopathy. In October, Health Canada (the country’s equivalent to the FDA) announced information regarding this eye disorder would be added to the “Warnings and Precautions,” “Post-Market Adverse Drug Reactions,” and “Consumer Information” sections of the Canadian label.

“In the post-market setting, pigmentary maculopathy has been reported with chronic use of Elmiron,” Health Canada said. “Visual symptoms included difficulty reading and prolonged dark adaptation.”

According to the notice, Elmiron patients should undergo regular ophthalmic exams to facilitate early diagnosis of pigmentary maculopathy.  Treatment should stop if the disorder is confirmed.

Elmiron Vision Problems on FDA Watch List

The FDA did add Elmiron to its so-called Watch List earlier this year.  But the agency has yet to confirm a link between Elmiron and vision problems, only that a potential risk has been identified. As a result,  the label continues to omit any mention of  Elmiron pigmentary maculopathy.

Because the Elmiron label lacks such a warning, many doctors and patients in the United States remain unaware of this possible side effect. As a result, pigmentary maculopathy caused by Elmiron may be misdiagnosed and allowed to progress.

Johnson & Johnson and its Janssen Pharmaceuticals subsidiary are facing several Elmiron lawsuits in the United States that accuse the companies of concealing the potential for pigmentary maculopathy. Among other things, plaintiffs question why the defendants have yet to update the Elmiron label in the United States, despite warning Canadian doctors and patients last October.