Elmiron (pentosan polysulfate sodium) is used for the long-term treatment of interstitial cystitis, a rare urinary disorder which causes severe bladder pain. Researchers have identified a potential link between Elmiron and a degenerative eye disorder. Up to 25% of people who took Elmiron for longer than 6 months may experience a drug toxicity that damages the macula of the eye and can result in vision loss.
Elmiron’s manufacturer, Janssen Pharmaceuticals and its parent company Johnson & Johnson may be facing a number of Elmiron vision loss lawsuits filed by people who have developed pigmentary maculopathy, macular damage, vision loss or blindness.
Symptoms of Pigmentary Maculopathy related to Elmiron use may include:
- Blurry vison
- Difficulty reading
- Loss of close vision
- Night blindness
- Dark spots
- Visual dimming
Elmiron and Maculopathy Research
Research presented at the 2019 meeting of the American Academy of Ophthalmology, showed that Elmiron (pentosan polysulfate sodium), used for long-term treatment interstitial cystitis, may result in drug toxicity which may cause a degenerative eye disorder. Pigmentary retinal maculopathy, a specific type of eye damage may develop in up to 25% or one in four people who take Elmiron for longer than 6 months.
The study was conducted after ophthalmologists in 2018 noted a number of patients with macular damage who were taking Elmiron. These ophthalmologists identified 140 long-term Elmiron users through the Kaiser Permanente – Northern California health system and were able to further examine 91 patients who had taken an average of 5,000 doses of Elmiron over 15 years. Retinal imaging and other testing showed that 22 out of the 91 patients, showed significant ocular damage, specifically maculopathy. Many of these patients had initially been diagnosed with another condition but further exam showed their disorders were drug toxicity related.
Most people who take Elmiron for interstitial cystitis will be on the medication for longer than 6 months, in some cases for years as it remains the only available treatment for a disorder which has no cure. For one-quarter of these Elmiron users, it may have resulted in eye damage and vision loss which they were not warned about.
Since the 2019 AAO meeting, a follow up study involving an additional 117 patients was published which appears to confirm the link between maculopathy and long-term Elmiron use. Hundreds of thousands of patients may have been exposed to toxic effects which may result in permanent vision loss, blindness, and disability.
Elmiron for Interstitial Cystitis
Interstitial cystitis (IC) is a chronic bladder condition which may be a part of a group of diseases involving urinary pain such as bladder pain syndrome (BPS) and overactive bladder (OAB). Unlike these disorders however, interstitial cystitis causes cellular changes to the tissue layer surrounding the bladder which result in severe bladder pain or pressure and pelvic pain. It may also result in urinary urgency and the need for frequent urination up to 40 times daily or more and may be triggered by other pelvic or abdominal conditions such as irritable bowel syndrome or endometriosis episodes.
IC has also been found to be more prevalent in patients who have other health disorders such as migraine headaches, severe allergies, fibromyalgia, and other immune disorders. The condition is so debilitating that many people with IC are unable to maintain full-time employment, even with treatment.
Elmiron is a low molecular weight heparin-like molecule which has similar anticoagulant and fibrinolytic properties which may increase the risk for bleeding, however the way that it works to treat IC is not well understood. Elmiron was first approved in 1985 as an “orphan drug” for the treatment of urinary pain associated with interstitial cystitis which was considered to be a “rare” disorder. Since Elmiron’s approval, the understanding of urinary conditions has grown, and the drug no longer is listed as an orphan drug, but it remains the only approved treatment for IC.
Interstitial cystitis treatment requires long-term use of Elmiron which is taken 3 times daily. If Elmiron treatment is successful at relieving pain episodes, the medication will be continued indefinitely.
Inadequate Warnings for Elmiron Eye Damage
Though the Elmiron-associated vision problems were identified at least as early as 2018, and further study has confirmed a link to drug toxicity, Elmiron’s FDA approved prescribing information still does not include warnings for vision changes, visual disturbance, macular damage, or any other eye conditions including pigmentary retinal maculopathy.
Ophthalmologists are recommending that patients who take Elmiron for interstitial cystitis and who do not show signs of vision loss should be screened for macular or retinal damage at least yearly. This may require retinal imaging studies above the normal eye exam unless conducted by a retinal specialist. If a macular disorder is identified, consultation with the eye doctor, treating physician and patient may be required to determine whether the medication should be discontinued.
In some cases, if vision disorder is identified early enough and Elmiron is discontinued, the damage may be limited. In more severe cases however, experts have suggested that progression may continue to occur even when the drug is stopped.
Elmiron Vision Loss Lawsuits
People who have taken Elmiron (pentosan polysulfate) for more than 6 months and developed vision loss, macular damage or other eye disorder may be eligible for compensation through a Elmiron lawsuit and should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.