What Is Elmiron?
Elmiron is a drug used to treat certain bladder disorders. Unfortunately, the people who take it for that purpose—even if they take it correctly—are at an increased risk of developing problems with their eyes, including a condition called pigmentary maculopathy.
If you or a loved one has developed eye and vision problems after taking Elmiron, you may be able to join a mass tort with other individuals who suffered the same or similar injuries.
What is Elmiron?
Elmiron is the brand name of a drug that doctors sometimes prescribe for interstitial cystitis (IC). Per Johns Hopkins Medicine, IC is a chronic bladder ailment that may result in:
- The inability to “hold it” for as long as you used to
- Painful sex
- Pain in and around the bladder or genitals
There is no cure for interstitial cystitis, but multiple treatments are available. This is what Elmiron is used for: to ease IC symptoms and improve the patient’s quality of life.
Elmiron’s generic name is pentosan polysulfate sodium (PPS). This is the drug at the center of the class action lawsuits.
Who Is Elmiron’s Manufacturer?
Janssen Pharmaceuticals is the company that manufactures Elmiron. They are responsible for:
- Developing the drug
- Testing the drug for safety issues and efficacy before putting it on the market
- Gaining FDA approval before attempting to sell the drug
- Marketing the drug’s benefits and warning patients of its potential side effects
- Recalling the drug if they discover a defect and publicizing the reasons for the recall
- Compensating anyone who was harmed due to their failure to comply with any of the above
What Class Drug is Elmiron?
Elmiron is classified as a miscellaneous genitourinary tract agent. These drugs are used to treat problems with the organs and systems regulating bowel and bladder movements and/or reproduction. Elmiron, as stated previously, treats interstitial cystitis, a bladder condition.
What to Do Before Taking Elmiron
Elmiron is a prescription medication, so the only way you can get it is by going to your doctor and receiving a prescription for it. Before prescribing any drug, your doctor should:
- Talk to you about the pain you are feeling
- Review your medical records and request any necessary tests to make an accurate diagnosis of IC
- Determine if there is any reason, such as another health condition, that you should not take Elmiron
- Go over all potential treatment options with you, including warning you about potentially harmful side effects
Only after performing all of these tasks should your doctor prescribe Elmiron. If you have any questions or concerns about taking Elmiron, bring them up to your doctor right away.
After prescribing Elmiron, your doctor should continue to monitor you throughout your treatment. This allows them to:
- Make sure the treatment is working
- Alter treatment if you experience troublesome side effects
- Stop treatment if side effects are severe or if the treatment is not working
How Should I Take Elmiron?
Elmiron is a pill and should be taken by mouth. You should take Elmiron with water but not with food.
According to the Food and Drug Administration (FDA), patients should take a 300-milligram dose of Elmiron three times a day. However, if your doctor prescribes a different dosage or frequency, do what they say, as they know you and your condition best.
If you are uncertain about how to take Elmiron, there should be directions on the prescription bottle or information packet that comes with the prescription. If these directions differ from what your doctor said, you can call your doctor or pharmacist to confirm which directions to follow.
What Happens if I Miss a Dose of Elmiron?
As with many other medications, you should not try to take an “extra” dose of Elmiron if you miss one. It is better to wait and take your next scheduled dose.
If you have any concerns about missing a dose, or if you have trouble remembering to take your medication, talk to your doctor. They can address any concerns you have.
What Happens if I Overdose on Elmiron?
The FDA states that no overdoses were reported during Elmiron drug trials, so the effects of and treatment for overdose they describe are based on the drug’s known properties rather than first-hand experience.
An overdose of Elmiron is likely to cause:
- Bleeding, including rectal hemorrhage
- Liver problems
- Gastrointestinal problems
- Thrombocytopenia (a low blood platelet count that, according to the Mayo Clinic, is often symptomless but can cause dangerous bleeding)
If you suspect that you have overdosed on Elmiron, get emergency medical care immediately. You may have to have your stomach pumped or receive another form of professional treatment.
What Should I Avoid While Taking Elmiron?
The FDA reports no particular drugs, drinks, foods, or activities that you should avoid while taking Elmiron. They do, however, warn that it is a “weak anticoagulant,” meaning that it may cause you to bleed more often or longer than normal. If you plan on having surgery shortly, you should not take Elmiron. Ask your doctor about how to safely stop taking Elmiron before surgery.
The FDA also warns that Elmiron should not be given to:
- Anyone under the age of 16
- Anyone who is breastfeeding or planning to breastfeed
- Pregnant patients (unless absolutely necessary)
- Anyone who has had an adverse reaction to PPS
If Elmiron has not helped to improve your condition after three months, see your doctor for a reevaluation. They may take you off the drug or recommend you keep taking it for another three months. If there is still no improvement after six months, the FDA suggests you stop this treatment.
The patients who do see improvement within three to six months may end up taking Elmiron for years. It is these patients—those with prolonged exposure to Elmiron—who are at the greatest risk of developing vision problems.
What Could Elmiron Do to My Eyes?
In 2018, researchers discovered a link between the drug in Elmiron—pentosan polysulfate sodium—and eye problems, particularly a condition called pigmentary maculopathy. According to the study, this condition causes patients to have difficulty reading and to need more time to adjust their eyes in the dark.
In the lawsuits filed against Elmiron’s manufacturer, many patients claim the drug has had various harmful effects on their vision and eyes. Other eye conditions and symptoms associated with prolonged exposure to Elmiron include:
- Macular degeneration
- Retinal maculopathy
- Blurry vision
- Eye pain
- Changes in eye color
- Light sensitivity
- Seeing spots
What Do I Do if I Experience Eye Problems While on Elmiron?
To determine if your eye condition may have been caused by Elmiron, you can:
- Make an appointment with your doctor as soon as possible
- Describe the changes in your vision, including when you first noticed something was wrong
- Keep all follow-up appointments and appointments with the specialists your doctor recommends
- Tell your doctor(s) that you are/were taking Elmiron and ask how likely it is that the drug is responsible for your vision problems
- Follow through with all treatments and other recommendations your doctor suggests
The information you get from your doctor could be invaluable for two reasons. First, it can slow or halt your vision loss, preventing symptoms from worsening or further impacting your life.
Second, medical reports and doctor’s statements are often key sources of evidence in legal actions. If you decide to join a mass tort against Janssen Pharmaceuticals, your medical records and testimony from a medical professional can:
- Establish a connection between Elmiron and your vision problems
- Contribute to a case strong enough to convince Janssen Pharmaceuticals that they should offer a fair settlement rather than let your case drag on
- Get you the compensation that your physical, emotional, and financial suffering entitles you to recover
Is it Safe to Take Elmiron?
The 2018 findings indicate that Elmiron may not be safe to take over an extended period, although they do caution that further research is necessary to uncover the full consequences of taking Elmiron.
If you are still taking this drug, do not stop abruptly. Speak to your doctor about your concerns and see if there are any other treatments you can try instead.
Elmiron Side Effects
According to the FDA, Elmiron clinical trials found the following side effects were reported most often:
- Nausea and diarrhea
- Hair loss
- Minor gastrointestinal problems, such as indigestion
- Liver problems
Less common side effects included anemia, tinnitus, vomiting, constipation, and photosensitivity, among others. These affected less than one percent of the test population.
Also among the less common side effects were a series of eye complaints, including:
- Optic neuritis
- Retinal hemorrhage
The FDA’s document on Elmiron says nothing about pigmentary maculopathy. Patients who took this drug were therefore completely unaware of the full extent of the damage that could be done to their eyes.
This is why there are now lawsuits against Janssen Pharmaceuticals: the company allegedly failed to fulfill its responsibility to consumers by properly warning them of Elmiron’s side effects.
Lawsuits Filed Against Elmiron
Since 2020, hundreds of people have filed lawsuits against Elmiron’s primary manufacturer, Janssen Pharmaceuticals, and other organizations involved in the drug’s manufacture, distribution, and marketing. These suits allege that:
- The organizations knew or should have known that Elmiron could cause vision problems
- Despite this knowledge, the organizations did nothing to protect patients from Elmiron’s harmful side effects
- As a direct result of the organizations’ inaction, the plaintiffs suffered significant and unnecessary harm
All manufacturers have a responsibility to take reasonable steps to ensure their products are safe for human use or consumption, and to remove their products from the market if they discover flaws or hazards. If they fail to live up to this responsibility, they could be subject to legal action.
Why File a Lawsuit Against Elmiron?
You took Elmiron because you were in pain and needed safe, effective relief. Janssen Pharmaceuticals promised that relief. Not only did they not provide it, they further worsened your health by exposing you to a dangerous drug that may have permanently damaged your vision.
You never should have had to suffer as you have. Since another party’s negligence caused this suffering, they may owe you monetary compensation for:
- Physical pain
- Emotional suffering
- Medical bills
- Loss of income or earning potential
- Disability And more
How much can you get from an Elmiron lawsuit? This is still undetermined, as the earliest cases against Janssen Pharmaceuticals are working their way through the courts right now. It often takes years for such cases to be resolved.
One of the prescription drug injury attorneys in our network can collect evidence to determine the exact value of your case and make sure you ask for a fair amount of compensation.
Elmiron Mass Torts
Many of the cases against Janssen Pharmaceuticals have been consolidated into what is called a mass tort, or class action. More specifically, they have been combined into a multidistrict litigation case or MDL.
According to the United States Judicial Panel on Multidistrict Litigation (JPML), MDLs allow individual lawsuits from around the country to be grouped into a single legal action, streamlining the legal process and saving plaintiffs money.
Do you qualify to join an existing MDL or even to start one of your own? That depends on the specifics of your case, including:
- Where you live
- What kind of effects you have suffered, including your official diagnosis and how it has impacted your life
- When you were diagnosed with your eye condition
We are in contact with lawyers around the country who have experience in handling MDLs and other mass tort cases. An attorney in your area can assess your situation and help you plan your next steps.
If You Took Elmiron, You Have Options
Call us at 1.844.44TORTS (1.844.448.6787) for a free case review today. We can connect you with one of the mass torts attorneys in our network who serves your community, has experience with prescription drug cases, and can represent you as you seek compensation from Elmiron’s manufacturer. They can tell you what your options are and guide you through the legal process.