Janssen Pharmaceuticals adds a new vision loss warning to Elmiron

After heavy criticism from the scientific community, Janssen Pharmaceuticals updated its label for its interstitial cystitis drug, Elmiron, to include the risk of vision loss. The company had already made this change in Canada and Europe but failed to warn U.S. consumers until now.

In 2018, several studies showed a correlation between long-term use of Elmiron and pigmentary maculopathy. This began when Dr. Neiraj Jain wrote a letter to the editor of the Journal of Urology alerting readers to the new condition they were noticing among their patients.

Several of the doctor’s patients had difficulty reading and adapting to areas of dim light. Furthermore, the medical professionals found that these patients had subtle spots on the retina of their eyes.

Dr. Jain published a second case series with 10 patients with a median age of 59 years who were currently using Elmiron or had used it in the past. All the patients showed similar symptoms of retinal damage.

Despite these studies, Janssen Pharmaceuticals refused to change the product’s warning label to address these concerns. In 2019 the European Medicines Agency demanded that Elmiron warning label be updated to warn consumers of the risk. Janssen adhered to the request but still did not change the label in the U.S.

Finally, in June 2020, the company added the new warning about eye disease to its Elmiron label. The new label says that pigmentary changes in the retina “have been identified with long-term use of Elmiron.”

Elmiron users may be eligible for financial compensation through an Elmiron lawsuit. More claims are being filed every month.