You may qualify to file an Elmiron lawsuit if you’ve developed vision problems as a result of long-term use of the medication. Elmiron is a prescription medicine manufactured by Janssen Pharmaceuticals for the treatment of interstitial cystitis, a condition of the bladder that causes pain and discomfort.
Thousands of individuals who have used Elmiron have filed lawsuits alleging that this medication caused damage to the retina, leading to eye conditions including macular degeneration, retinal maculopathy, and pigmentary maculopathy. Elmiron users should be aware of the pending lawsuits and the manufacturer’s potential liability. Individuals who experienced vision changes may pursue a product liability claim to recover compensation from the manufacturer.
What Is Elmiron Used to Treat?
Elmiron, the brand name for pentosan polysulfate sodium, is a weak anticoagulant drug. It is an oral prescription medication approved by the U.S. Food and Drug Administration (FDA) in 1996 for the treatment of Interstitial Cystitis (IC), commonly known as painful bladder syndrome. This is a condition that affects the bladder, causing chronic pain and pressure that impacts urinary frequency. While this condition can affect anyone, more than 90% of patients are female. In fact, about one in four million men and three in eight million women in the U.S. have interstitial cystitis.
The actual cause of IC is not yet known, but certain food items, beverages, and activities are believed to trigger symptoms. For instance, affected individuals have reported symptom flares with stress, intercourse, eating acidic food, wearing tight undergarments, or holding their urine.
Symptoms of IC include:
- Urinary urgency several times a day
- Tenderness, pressure, or mild discomfort in the bladder, pelvic area, or lower abdomen
- Pressure as the bladder fills with urine
- Urinating more often
- Pain or burning sensation
- Pain during or after sexual intercourse
- Pain that worsens when the bladder is full
- Pelvic floor muscle pain
- Pain when urinating
How Does Elmiron Work?
While researchers don’t understand precisely how Elmiron works, they strongly believe it acts like a natural substance in the lining of the bladder, protecting the bladder from irritants in urine. Unlike other painkillers, such as Tylenol or non-steroidal anti-inflammatory drugs like ibuprofen, Elmiron does not work by stopping inflammation.
IC, or bladder pain syndrome, is a chronic condition that triggers excruciating symptoms in the bladder. Elmiron does not cure IC. However, it offers some relief from severe symptoms. Interstitial Cystitis damages the protective bladder walls, allowing irritating substances in urine to cause inflammation in the bladder wall. The drug is thought to ease bladder pain and distress by creating an extra coating of protection on the inner bladder walls, alleviating painful irritation resulting from urine.
According to the medication insert, the manufacturers of Elmiron conducted a drug test in two clinical trials with 2,627 patients. Of those participants, 262 were men, 2,343 were women, and 22 were unknown. During the second trial, which was conducted three months after the first one, 1,307 participants dropped out or were disqualified from taking part in the analysis.
The results of these studies revealed that Elmiron provided pain relief to many patients. Reviews from most patients demonstrated pain relief within three months. A small percentage of patients, however, took up to six months to experience pain relief. But a different study conducted on a smaller number of patients established that Elmiron did not offer many benefits to a sizable number of IC patients.
What Side Effects Are Caused by Elmiron?
Elmiron side effects are generally mild and stop after the body gets used to the drug. Most patients tolerate the medication quite well. Here are the most common side effects of Elmiron:
- Abdominal pain
- Blood in the stool
- Hair loss
- Upset stomach
During the clinical trials, these common Elmiron side effects occurred in 1% to 4% of patients who took part in the trial. Thirty-three patients (1.3% of participants) experienced severe side effects. Six deaths were recorded, although this appears to have been caused by other health concerns.
Hair loss or alopecia was the most common side effect reported. Alopecia developed in the first four weeks of treatment. The majority of patients (97%) experienced alopecia in a single spot. In almost all cases, hair loss stopped and hair grew back after they stopped taking Elmiron. In all trials, there was no follow-up after a year of Elmiron use.
According to the drug’s prescribing information, 1% or less of the participants experienced rare side effects. Some of these rare but severe side effects of Elmiron include:
- Anemia and related blood abnormalities
- Allergic reactions
- Cold-like symptoms
- Itchy skin
- Retina hemorrhage
- Shortness of breath
- Mouth ulcers
- Colitis constipation
- Ring in the ears (tinnitus)
- Pink eye (conjunctivitis)
The most common visual symptoms reported by patients in the Elmiron studies are difficulty reading, blurred vision, difficulty adjusting to changes in lighting, far-sightedness, dark spots in vision, dulled color perception, flashing lights, eye pain, metamorphosia, and partial or complete blindness.
Elmiron Linked to Eye Damage
There have been recent concerns that people who take Elmiron for long periods of time are at a higher risk of developing eye problems or vision loss. Since its initial release, Elmiron has always been viewed as a safe drug with few serious side effects or serious risks. That changed in 2018, when the world began to develop a concern about the drug’s side effects.
The first report of eye damage associated with long-term use of Elmiron was published by a group of Ophthalmologists from the Emory Eye Center in Atlanta. They had six female patients with abnormal damage to the sensitive retinal tissue who were diagnosed with pigmentary maculopathy. Their common trait is that they were all taking Elmiron.
This warning call prompted further studies into the safety of Elmiron and its potential toxicity to the eyes. A team of ophthalmologists in Northern California conducted studies based on thousands of patient records. It was concluded that Elmiron was toxic to the retina tissue of the eye, causing a “vision-threatening” eye condition that could be masked as other known maculopathies. About 25% of Elmiron users displayed signs of maculopathy or significant eye damage. Specifically, patients who have used Elmiron face a substantially increased risk of retinal maculopathy, pigmentary maculopathy, or macular degeneration.
Many of the patients already had partial or total vision loss. When doctors examined and tested these patients, they found clear signs of toxicity related to long-term exposure to Elmiron. Data from the research revealed 10 patients with Elmiron-related eye damage signs. Half of them underwent fundus examinations. The other half underwent imaging. Results also show that these patients took Elmiron for 3 years or more, with an average cumulative dose of 380g. The imaging could detect maculopathy related to Elmiron.
Current theories suggest that the drug could be toxic to the retina, and causes irreversible damage to the retinal pigment epithelium, which is a special layer of cells that help maintain visual function and the visual cycle. Because Elmiron is believed to cause damage to this pigmented layer, the emerging eye disease has been dubbed “pigmentary maculopathy” or “pentosan-associated maculopathy” after the generic name for Elmiron.
On examination, ophthalmologists have noted varying signs of Elmiron-induced eye disease, including:
- Dark or hyperpigmented spots near the retina
- Abnormal blood vessels around the macula (Parafoveal Pigmented Deposits)
- Round, yellowish lesion beneath the macula (Vitelliform Deposits)
Many patients who were initially diagnosed with various eye conditions may have lost vision due to a failure to link their maculopathy to Elmiron, rather than the age or genetic-related conditions. Current research shows that maculopathy appears to be limited to Elmiron use and hasn’t been seen in patients using other types of medication or treatment for interstitial cystitis.
Jansen Pharmaceuticals Did Not Warn Users About the Risk of Eye Damage
While the medical community has only recently learned of the connection between Elmiron and eye damage, Elmiron lawsuits allege that the manufacturer may have known of the risk of eye damage for more than 20 years, but failed to adequately warn the public.
In clinical trials of patients who used Elmiron for up to 4 years, eye-related adverse events were reported. The company never conducted further research on Elmiron’s toxicity to the eyes, and never warned patients and their doctors regarding the potential for eye damage and vision loss. They ignored the risks and went on to increase their bottom line as the only FDA-approved manufacturer of painful bladder medication.
In April 2020, Elmiron’s warning label was updated in Canada to reflect the following safety information:
Chronic use of Elmiron has been linked to pigmentary maculopathy. Visual symptoms include prolonged dark adaptation and difficulty reading. Patients should have regular eye examinations to detect the onset of pigmentary maculopathy. Treatment should be discontinued if pigmentary maculopathy is confirmed.
This warning label, however, was not immediately made available in the U.S., a subject explored through discovery efforts in the litigation against Janssen Pharmaceuticals. In June 2020, changes were made in the U.S. to include the warnings on the Elmiron package insert/warning label. Failure to warn patients of the risk creates grounds for medical malpractice.
What Consumers Need to Know About Elmiron
Given the latest research and warning label enhancement, patients currently taking Elmiron should consult with their prescribing doctor to reassess whether the benefits of long-term or high-dose Elmiron use outweigh the potential ocular adverse effects. Since pigmentary changes in the eyes can be caused by various factors, patients should share their family medical history with their healthcare provider to help distinguish genetic issues from Elmiron-related macular damage.
If a patient without any vision changes chooses to remain on the medication after a consultation with his or her physician, he or she is advised to undergo regular examination, imaging, and monitoring for eye toxicity. But, if a person experiences vision changes or exam results show pigmentary abnormalities, he or she should work with his or her doctor to reassess the benefits and risks of taking Elmiron.
Elmiron causes irreversible eye problems, and it may no longer be a good idea to continue treatment with the drug. Follow-up exams should continue, even after a patient stops taking the medication. Elmiron-related eye damage has been found to worsen even after stopping treatment.
For individuals considering Elmiron as a treatment option for interstitial cystitis, they should also have an open and thorough discussion with their doctor regarding their pre-existing eye conditions or their family’s history of eye disease. Physicians should conduct tests to measure the patient’s eye health before prescribing Elmiron, and routinely thereafter. The pre-treatment exam results will make it easier for doctors to detect pigmentary changes during the treatment period.
Am I Eligible to File an Elmiron Lawsuit?
The first lawsuit against Janssen Pharmaceuticals was filed in January 2020, shortly after the warning label was changed. The plaintiffs allege that Elmiron triggered unexpected damage to the eye, causing them to develop pigmentary maculopathy, loss of night vision, retinal hemorrhage, and vision degradation. They claim that Janssen Pharmaceuticals may have been fully aware of the risk of permanent eye damage but failed to warn doctors and the FDA of the risk. As such, the manufacturer is responsible for eye damage and vision loss caused by Elmiron.
Since then, thousands of individuals have filed Elmiron lawsuits. A Multi-District Litigation (MDL) was created to manage these cases. An MDL is the similar to a class action in that it allows many claims to be resolved at once through a legal settlement. But unlike a class action, an MDL consolidates several independent cases before the same judge for expediency and efficacy. As a result, each plaintiff can obtain compensation befitting his or her circumstances.
The Elmiron MDL was created in a U.S. District Court in New Jersey, and the presiding judge is Judge Brian Martinott. As of March 2023, there are 1,880 claims in federal MDL. When an MDL is formulated, bellwether test trials are conducted, where certain plaintiffs present their cases to give all the involved parties a clue of the possible outcome of the legal action. The first bellwether trial began on March 27, 2023.
If you or a loved one has a confirmed diagnosis of eye problems after long-term use of Elmiron, you may qualify to file an Elmiron lawsuit. Attorneys have a set of criteria that could determine if you qualify to join the MDL:
- You used Elmiron for at least two years
- You experienced vision issues, including distorted or blurred vision, difficulty adjusting to darkness, vision disturbances, eye pain, difficulty reading, or vision loss that happened on or after Jan.1, 2010
- You sought medication for vision issues
- You were diagnosed with vision issues or started experiencing vision issues while using Elmiron or within one year of discontinuing treatment with this medication.
- You were diagnosed with ocular problems, such as macular degeneration, retinal maculopathy, or pigmentary maculopathy after using Elmiron.
You may be eligible to file an Elmiron lawsuit if you meet these criteria. However, only a medication malpractice lawyer can provide detailed information on eligibility to file a suit.
Consult with an attorney as soon as possible. The statute of limitations for filing product defect or medication malpractice cases in Illinois is two years from the date a person discovers the claim or receives the notice of the error. If you file your claim promptly, you’ll have little to worry about.
Why Should You File an Elmiron Lawsuit?
If you’ve used Elmiron to treat interstitial cystitis and subsequently developed permanent vision problems, filing a lawsuit can help you get compensation for physical, emotional, and financial harm. Compensation for Elmiron eye injury may include:
- Past and future medical expenses
- Past and future income lost due to vision impairment
- Pain and suffering caused by vision loss
- Loss of quality of life
- Emotional distress
- Other tangible and intangible costs associated with vision impairment
Elmiron lawsuits hold the manufacturers accountable for negligence. When these cases go to trial, individuals injured by Elmiron may be awarded punitive damages. These are damages awarded by the jury to punish the defendant for malicious behavior or gross negligence and to discourage further negligent behavior.
Filing an Elmiron lawsuit also allows plaintiffs to bring awareness to the adverse effects of Elmiron and to warn others from suffering irreversible eye damage.
The amount of damages each plaintiff can recover in an Elmiron lawsuit will likely be determined by the level of his or her vision impairment. Severe eye impairment will cost more to treat and have a greater physical, financial, and emotional impact. This will directly correlate with the amount a plaintiff can recover once the case is settled.
It is better to talk with an experienced product liability attorney to have an understanding of what amount of compensation you’re likely to receive.