Federal Regulators Add Elmiron Warnings To U.S. Label

Federal Regulators Add Elmiron Warnings To U.S. Label

Introduction

On June 16, the FDA finally changed the label for Elmiron in the U.S., indicating the risk of eye disease associated with the drug. The new warning label was the result of multiple research studies and peer-reviewed publications, an FDA citizen petition, and a growing number of lawsuits.

The new warning label will alert doctors and patients about retinal pigmentary changes and the cause of maculopathy among long-term users of the interstitial cystitis drug.

Elmiron, also known by its generic name pentosan polysulfate sodium, or PPS, is an oral prescription drug that is used to treat pain/discomfort caused by bladder disorder interstitial cystitis, or IC.

The drug is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and was approved by the U.S. Food & Drug Administration (FDA) in 1996. The drug is approved under the Orphan Drug Act or ODA, which gives special status and incentives to sponsors, or manufacturers, of medications that treat rare diseases.

Several studies and a growing number of lawsuits filed in recent years claimed that long-term exposure to Elmiron has serious eye-related side effects and causes maculopathy, an eye disorder affecting the macula, central part of the retina, which is a major cause of blindness. Many experts have referred to the retinal disease to “Elmiron maculopathy” or “PPS maculopathy. It is also a weak blood thinner and, therefore, may increase the risk of bruising/bleeding.

The revised label also encourages urologists to ask patients if there is any family history with eye disease and also recommends baseline retinal examinations for every patient using the drug within six months and on an on-going basis to determine if their retinas are being effected.

Elmiron, also known as pentosan polysulfate sodium or PPS, is sold by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary in the U.S. and is used to treat interstitial cystitis or “painful bladder syndrome,” a chronic condition with no known cure. The users of the drug are required to stay on the treatment for years or even decades. The side effects of the drugs are usually seen after three years of use or longer, but there have been cases with a shorter duration of use.

The vision loss warning of Elmiron for its Canadian version of the drug was revealed back in October 2019. However, this is the first time, the warning will be added in labels for the interstitial cystitis drug produced in the U.S. 

The warning states about all visual symptoms that include reading difficulty, problems in adjustment to low light environments, and blurry vision. Even the healthcare professionals are warned to study the ophthalmologic history of all patients before prescribing them with Elmiron. 

Macular retinopathy, which can cause by Elmiron can lead to deterioration of the retina. Since there is the risk of damage associated with the use of Elmiron, drug makers have mentioned in the warning that any changes in vision after intaking this interstitial cystitis drug should be reported to the doctor. Until now no label warnings were mentioned on Elmiron drug, therefore many consumers are still unaware of the vision loss side effects, also many doctors have now started to learn about the risks. 

The number of lawsuits being filed by former users throughout the U.S. is on the rise. The lawsuits allege that permanent retinal damage could have been avoided if the warnings about the side effects were provided earlier.