Elmiron, also known as pentosan polysulfate sodium, is a prescription only drug used to treat bladder pain. The drug is most commonly prescribed for interstitial cystitis, or IC. Interstitial cystitis is a chronic condition that causes bladder pain and pressure, a condition most commonly found in women. The most common side effects found associated with Elmiron were hair loss, diarrhea and nausea, but a recent study has found that the drug could be toxic to the retina within the eye.
In an effort to encourage research and development of medication for rare diseases, the FDA enacted the Orphan Drug Act, or ODA, in1983. The ODA was passed to help facilitate development of drugs used to treat rare diseases, such as Huntington’s, ALS, IC and more. The law provided financial incentives to manufacturers to attract interest through a seven-year period of market exclusivity for drugs approved to treat orphan diseases, or rare diseases. These financial incentives included tax credits of up to 50 percent for research and development expenses. Elmiron was manufactured by Janssen Pharmaceuticals (owned by Johnson & Johnson) under the ODA, and approved for sale in 1996 by the U.S. Food and Drug Administration or FDA.
Currently, Elmiron is the only oral prescription approved to treat bladder pain and discomfort caused by IC. It’s estimated that between 4 and 12 million people are affected by IC. Interstitial Cystitus can also be referred to as painful bladder syndrome (PBS), bladder pain syndrome (BPS), and chronic pelvic pain (CPP)
Pigmentary Maculopathy Side Effects
As stated previously, the most common side effects of chronic Elmiron use are hair loss, diarrhea and nausea, but recently new research by the American Academy of Ophthalmology uncovered that the drug could be toxic to the retina.
These studies found that chronic exposure to pentosan polysulfate sodium (Elmiron) can cause pigmentary maculopathy. Maculopathy is an eye disorder affecting the macula (central part of the retina) and a major cause of blindness. Pigmentary maculopathy is characterized by pigmented deposits that look like little specks floating in the retina.
Since the original study, a handful of other studies have provided similar evidence that this IC drug increases the risk of developing this type of maculopathy. Users complained of many symptoms including dim vision, difficulty reading, difficulty adjusting to different lighting, minor vision loss, and in some cases, full permanent blindness. Early on most people don’t suffer from any symptoms, but over time the damage becomes significantly more severe.
Soon after these studies were initially conducted lawsuits began to be filed from patients claiming they were never warned about this horrible side effect before being prescribed the medication.
If you or a loved one has used Elmiron for more than 6 months and have suffered from any of the following symptoms and/or have been diagnosed with Pigmentary Maculopathy or any Retinal Pigmentary Changes please contact us today.
- Prolonged light to dark adaptation
- Blurred vision
- Central vision loss (as opposed to peripheral vision loss)
- Dimming of vision, blind spots, floaters, spots, impaired color vision, difficulty with near vision