At the 2019 meeting of the American Academy of Ophthalmology, research was presented showing that Elmiron (pentosan polysulfate sodium), used for long-term treatment of a rare urinary disorder, interstitial cystitis, may cause a degenerative eye disorder. A unique type of ocular damage, pigmentary maculopathy, may develop in as many as 25% of long-term users of Elmiron.
Some of the patients who were identified in the study of the ocular disorder, had originally been diagnosed with another eye condition such as macular degeneration or pattern dystrophy but additional testing showed a link to their medication use. Some of these people may be filing Elmiron vision loss lawsuits against Janssen Pharmaceuticals, a division of Johnson & Johnson.
Elmiron and Interstitial Cystitis
Elmiron is the brand name for pentosan polysulfate sodium and is manufactured by Janssen Pharmaceuticals, a division of the healthcare giant, Johnson & Johnson. Elmiron was approved in 1985 as a medication listed under the “orphan drug” status which is a classification given to medications that are one of a few or the only treatments available for rare disorders.
It is approved for the relief of bladder pain or discomfort associated with interstitial cystitis (IC). Since Elmiron was approved, the understanding of interstitial cystitis has grown, and the drug is no longer classified as an “orphan drug” due to an expanding number of people with the disorder.
Elmiron is classified as a low molecular weight heparin-like compound which has anticoagulant and fibrinolytic properties but the exact way that it works to treat interstitial cystitis is not known. Elmiron is taken as a three times daily regimen of 100mg on an empty stomach. Patients who begin the medication are reassessed at 3 months and treatment may be continued for another 3 months if no improvement is seen.
Patients whose interstitial cystitis treatment is successful with Elmiron will often be on the medication for a long period of time, potentially indefinitely. People who have developed ocular disorders or vision loss due to Elmiron have been on the medication for longer than 6 months.
What is Interstitial Cystitis?
Originally a rare disorder, interstitial cystitis (IC) is a chronic bladder condition which is one of a spectrum of diseases that has been growing in understanding. It is part of the group of diseases receiving more attention, known as “painful bladder syndrome” or “bladder pain syndrome” (PBS or BPS).
Interstitial cystitis may affect 1 million or more people in the U.S., primarily women. It causes recurring episodes of discomfort, pressure or pain in the bladder and pelvic region and may be accompanied by a need to urinate frequently, sometimes as many as 40-60 times per day. Symptoms of IC may emerge slowly and worsen over a period of months. They may also change from day to day and may be triggered by other conditions such as episodes of irritable bowel syndrome or endometriosis.
Interstitial cystitis has symptoms which may be similar to another urinary condition, overactive bladder syndrome (OAB) which also causes urinary urgency. Unlike OAB however, interstitial cystitis, may result in cellular changes in the tissue layer surrounding the bladder, the urothelium.
The specific cause is unknown but other disorders are often associated with interstitial cystitis including allergies, migraine headaches, irritable bowel syndrome, fibromyalgia and chronic fatigue syndrome, Unfortunately, the condition is excruciatingly painful and only about half of all people with IC are able to maintain full-time employment.
Elmiron Vision Disorder
In 2018, ophthalmologists noted a trend of patients who were on Elmiron for the treatment of interstitial cystitis who developed vision problems or macular disorders. These ophthalmologists conducted a review of patients at Kaiser Permanente in Northern California and determined that up to 25% of patients using Elmiron for long-term treatment of urinary pain associated with interstitial cystitis had developed eye damage of some type.
Some of these patients had initially been diagnosed with other conditions including age-related macular degeneration, pattern dystrophy or other disorders but further examination showed that the disorders were likely related to long-term Elmiron toxicity affecting the macula of the eye, a layer of tissue in front of the retina. Degeneration or destruction of the macula may lead to vision loss or blindness.
Data presented at the 2019 meeting of the American Academy of Ophthalmology showed that researchers had identified 140 patients who had taken an average of 5,000 Elmiron doses over about 15 years. Of these patients, researchers were able to obtain further exams from 91 and found 22 or about one-quarter of these patients showed significant signs of drug toxicity as the development of pigmentary retinal maculopathy, a degenerative eye disorder which appears to be unique. The greater the exposure or longer the medication had been taken, the higher the risk for damage. In addition, damage did not appear to stop progression once the medication was discontinued.
Symptoms of vision disorder in Elmiron patients include:
- Blurry Vison
- Night blindness
- Difficulty reading
- Dark spots
- Loss of close vision
- Visual dimming
Inadequate Warnings for Elmiron Eye Damage
Though the vision problems have been identified since at least 2018, Elmiron prescribing information does not include any warnings for visual disturbance, vision changes, macular damage, or any other eye conditions.
Ophthalmology experts recommend that patients taking Elmiron should be screened for retinal damage at least once per year. Retinal screening for pigmentary maculopathy may require imaging studies and/or a consultation with a retina specialist. If a disorder is identified early and the medication is discontinued, damage may be mitigated but in more severe cases, damage may continue to progress.
Filing an Elmiron Vision Loss Lawsuit
Past drug injury lawsuits have provided compensation for medical costs, lost wages, pain and suffering, disability and other damages. People who took Elmiron for more than 6 months for pain associated with interstitial cystitis and developed vision loss, eye problems or were diagnosed with a macular disorder like pigmentary maculopathy may be eligible for compensation and should seek legal assistance.