Elmiron is a prescription drug that is used to treat bladder pain/discomfort. Elmiron is made of pentosan polysultafe sodium (PPS) and has been on the market since 1996. It was originally created by Teva Pharmaceuticals and is now sold by Janssen Pharmaceuticals (a division of Johnson & Johnson). Janssen owns the license to Elmiron and has since the inception of the drug.
PPS is used to treat bladder pain and discomfort from a bladder disorder called interstitial cystitis (IC). Scientists don’t exactly know how PPS works in the body, but it may create a layer in the bladder wall that protects the bladder wall from irritating substances in urine. People with IC can go to the bathroom 40-60 times a day.
Estimates show that between 3-8 million women and 1-4 million men have IC. Elmiron is the only FDA approved medication to treat IC. There is no generic on the market.
Scientific Research (2 key studies):
- Emory University: From 2015-2018, Emery Eye Center identified through advanced retinal imaging an entirely new eye disease in 6 of their patients. This new disease was classified as retinal pigmentary maculopathy and occurred in 6 patients taking Elmiron. On retinal scans, the disease looks almost identical to age-related macular degeneration, and is often mis-diagnosed as such. Emory’s case studies were published in a paper in the Journal of Ophthalmology in May 2018 showing the connection between the new eye disease and Elmiron.
- Kaiser Permanente. Three ophthalmologists conducted a review of patients at Kaiser Permanente in Northern California. They found that about one-quarter of patients with significant exposure to Elmiron showed definite signs of eye damage, and that this medication toxicity could masquerade as other known retinal conditions, such as age-related macular degeneration or pattern dystrophy. Their results were presented to and published in the American Academy of Ophthalmology.
Numerous studies have now shown a correlation between Elmiron and the eye disease. At least one documented case shows a patient that developed retinal pigmentary maculopathy years after she stopped taking Elmiron.
Symptoms of Retinal Pigmentary Maculopathy include:
- Difficulty reading
- Difficulty adapting to dim light
- Blurred vision
- Dark spots in center of vision
- Straight lines appearing curved
- Muted or less vivid colors
- Loss of vision
Vision does not improve when a patient stops taking the drug, and the damage is irreversible. If caught early, treatment can slow the progression of vision loss.
Recent label change:
The original clinical trials of Elmiron in the 1990s show that the drug impacted the eye, causing optic neuritis (inflamed optic nerve) and retinal hemorrhaging (bleeding). However, no warning regarding eye health was ever listed and no additional testing was conducted.
On June 16, 2020, the FDA approved a label change that includes a warning for retinal pigmentary changes. The full text of the new label can be found here.
The drug is still on the market and there has been no move to issue a recall.
Key allegations and status of litigation:
- By approximately 2001, Defendant had reasonable evidence of a causal association between serious vision-related injuries and Elmiron use.
- By approximately 2001, Defendant learned Elmiron use could cause serious vision-related injuries.
- Despite reasonable evidence of causal association, Defendant knowingly withheld and/or misrepresented information required to be submitted under FDA NDA regulations, concerning the safety and efficacy of Elmiron, including, but not limited to, raw data sets, documents, data analyses, and/or other information related to the risk of Elmiron users suffering vision-related injuries as a result of their Elmiron use. Such information was material and relevant to the risk of patients, like Plaintiff, developing serious vision-related injuries as a result of taking Elmiron.
- From approximately 1997 to the present, Defendant received multiple Adverse Event Reports (“AER”) from medical professionals concerning Elmiron. These AERs included serious visual complication believed to be associated with Elmiron use, ranging from retinal hemorrhage to macular degeneration to even unilateral blindness.
- Despite post-approval adverse event reports and other clinical evidence, Defendant failed to continue to test and study the safety and efficacy of Elmiron, particularly in patients who used the drug for long periods of time.