Elmiron Vision Damage Lawsuits
Studies Link Elmiron with Vision Damage
Jain and colleagues continued their research, and in April 2019, published a second case series, identifying 10 patients with a median age of 59 years who had been diagnosed with IC and either were currently using Elmiron or had used it in the past. All of them showed symptoms of pigmentary maculopathy. The researchers encouraged the patients to stop taking the drug.
More studies followed. Scientists at Kaiser Permanente found that of the 140 of their patients who had taken Elmiron for a minimum of 5 years, 22 (24 percent) showed eye damage. The greater the quantity of Elmiron taken, the greater the damage.
Another study followed in November 2019. Using data from a large U.S. medical claims database between 2002 and 2006, researchers found that patients taking pentosan for seven years or longer were at an increased risk of having maculopathy.
Further studies are needed to firmly establish a causal link between Elmiron and pigmentary maculopathy. The drug has been on the market for decades and thousands of people have taken it, most for many years. These studies raise concerns that many more patients may already have some vision damage or may be at risk but don’t know it yet.
Types of Injuries Associated with Elmiron
Long-term intake of Elmiron (PPS) may result in:
- Blurred vision
- Difficulty reading
- Dark spots in the center of vision
- Muted, less vivid colors
- Difficulty adapting to dim lighting
- Straight lines appearing curved or squiggly
- Degenerative maculopathy
- Macular retinopathy
- Eye damage
- Vision impairment
- Vision loss
Doctors Notice Unhealthy Vision Changes in Patients Taking Elmiron
Elmiron is known to have few side effects, including minor gastrointestinal disturbances like nausea, diarrhea, and gastric distress, as well as headaches, dizziness, and itching or skin rash. A small percentage of patients have reported hair loss that is reversible once they stop taking the drug.
Recently, however, studies indicate that Elmiron may have the potential to cause serious vision damage. In the spring of 2018, Dr. Neiraj Jain and colleagues wrote a letter to the editor of the Journal of Urology alerting readers to a new condition they were seeing among their patients taking Elmiron. Specifically, they had observed unhealthy vision changes in six patients who had been using Elmiron for several years.
The researchers published their findings later that year in the journal Opthalmology. They pointed out that all patients suffering from this new type of eye damage reported difficulty with reading and adapting to areas of dim light and had subtle hyperpigmentations (spots) on their retinas. Concerned about potential drug toxicity, they decided to investigate further.
In a retrospective cross-sectional study evaluating all patients with IC seen at the Emory Eye Center over four years, the scientists identified 219 patients with IC, 80 of whom had taken PPS. Fourteen of them had characteristic maculopathy.
Maculopathy refers to a certain type of damage to the macula—the central part of the retina—that provides humans with central vision. All of the cases of maculopathy occurred in patients who had taken PPS. Not a single case was found in patients who had not taken the drug.
Upon further analysis, the researchers found that exposure to PPS was the only factor significantly associated with this unique type of maculopathy. It was considered “unique” because it was unlike any other type of maculopathy seen before. The researchers named it “pigmentary maculopathy” because it involved the development of excess capillaries or pigmented spots over the macula that damaged vision.
International Cystitis Network Encourages FDA to Change Elmiron Label
In April 2019, the ICN submitted a Citizen Petition to the FDA requesting that they require Elmiron manufacturer Janssen Pharmaceuticals to update its product label to include a warning about eye damage. “Patients should be notified that there is a strong association between retinal disease and pentosan use,” the petition read. “Annual eye examinations are suggested.”
The group also conducted an informal survey of IC patients. With close to 1,000 respondents, results showed that 53 percent of Elmiron users reported eye and/or macular disease.
In the summer of 2019, the European Medicines Agency (EMA) demanded changes to the Elmiron label, and Health Canada followed in October 2019, requiring similar changes. Manufacturer Janssen Pharmaceuticals followed those recommendations and made those changes, but at that time left United States users in the dark.
Finally, as a result of mounting evidence linking Elmiron to vision damage and pressure from the ICN, Janssen Pharmaceuticals recently changed the label for Elmiron products sold in the U.S. The new verbiage warns patients that pigmentary maculopathy has been identified with long-term use of Elmiron and that cases had been seen with shorter duration of use as well. On June 16, 2020, the FDA approved the changes.
The new warning also suggests a baseline retinal examination for all patients within six months of initiating treatment and periodically while continuing treatment—a recommendation first put forth by scientists and doctors researching this condition.
The company had previously made similar changes in other countries.
What is Interstitial Cystitis?
Interstitial cystitis (IC) is a chronic condition that affects the bladder, causing symptoms like recurring pain and pressure in the bladder area, urinary frequency and urgency, and sometimes pelvic pain. The pain ranges from mild to severe and can be bad enough to qualify as debilitating, making it difficult for people to go about their normal daily activities and interfering with their quality of life.
Also called painful bladder syndrome (PBS), IC has two recognized subtypes:
- Non-ulcerative: The majority of patients with IC have this form of the condition, in which pinpoint hemorrhages occur in the bladder wall. The bladder looks irritated and inflamed.
- Ulcerative: Only about 5-10 percent of IC patients have this type, which is characterized by red and bleeding ulcers or patches on the bladder wall. This type is often more severe and can be extremely painful.
IC typically causes recurrent symptoms—many patients have pain that comes and goes, while others experience a more steady pain. Though IC is not an infection, it can feel like a bladder or urinary tract infection. It can also cause pain during intercourse and may appear alongside other conditions like irritable bowel syndrome and/or fibromyalgia.
So far, doctors don’t know what causes IC, but the following factors may be involved:
- A defect in the bladder tissue that allows irritating substances in the urine to penetrate the bladder wall.
- A defect in the immune system producing a specific type of inflammatory cell that releases histamine and other chemicals leading to IC symptoms. Or, an immune system defect that causes the immune system to attack the bladder.
- Something in the urine that damages the bladder.
- Changes in the nerves that carry bladder sensations making the bladder over-sensitive.
Currently, there is no cure for IC, so treatments are focuses on relieving symptoms.
What is Elmiron?
Elmiron (pentosan polysulfate sodium or PPS) is a prescription drug used to treat bladder pain and discomfort associated with IC. It is the only prescription drug approved by the FDA specifically for treating IC and came onto the market in 1996. Patients typically take a 100 mg capsule three times a day. Relief from symptoms sometimes takes as long as three-to-six months to occur, and patients have to keep taking the drug for continued benefit.
Before Elmiron came onto the market, treatments for IC were limited and included diet modification, bladder distention procedures, and the use of other drugs requiring painful administration by a catheter. These treatments also provided only short-term relief, after which they’d have to be repeated.
Elmiron offered thousands of patients a welcome option for treating IC and has remained a popular choice among healthcare providers. Scientists aren’t sure why it works as it does. They think it helps restore damaged tissue in the bladder and provide a protective coating over the bladder wall, protecting it from irritating substances in the urine. It may also offer some anti-inflammatory action.
In double-blind, placebo-controlled clinical trials used to gain approval for Elmiron, 38 percent of patients taking Elmiron for three months reported improvement in their IC symptoms. In open-label trials, 61 percent of patients reported improvement.
Doctors also use other medications off-label to help ease IC symptoms, including antidepressants and antihistamines, sometimes combining these with Elmiron. The patent for Elmiron expired in 2010, but to date, there are no generic options available. Meanwhile, the manufacturer has repeatedly increased the price over the past several years.
According to the Interstitial Cystitis Network (ICN), ten years ago, Elmiron cost about $200 for a prescription. Today, that price has gone up to $1,000 or more.
Several Elmiron vision damage lawsuits have already been filed in various courts around the country. Plaintiffs claim that Janssen Pharmaceuticals knew or should have known that the drug could increase the risk of vision problems, and should have provided warnings to patients long before this.
If you took Elmiron regularly and were later diagnosed with pigmentary maculopathy or other forms of vision damage or vision loss, you may be eligible to file an Elmiron lawsuit to recover damages. Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.