What Is Elmiron?

Elmiron is a prescription medication that treats interstitial cystitis, known as IC. The drug, the only FDA-approved treatment option on the market for IC, eases bladder pain and discomfort for people with the chronic condition. Experts estimate that women use the drug most often of the hundreds of thousands of people using Elmiron. In most cases, Elmiron users take the drug long-term.

Like many drugs, Elmiron has side effects. While many of these side effects are mild, some medical experts believe the drug damages the human retina. This article will detail Elmiron’s side effects, dosage recommendations, warning signs, reasons for the mounting litigation against the makers of Elmiron, and more. If you have been negatively impacted by Elmiron, contact an experienced Elmiron lawsuit attorney today.

How Elmiron Works

Elmiron comes as an opaque, hard gelatin capsule. Each pill is stamped with an imprint reading “BNP 7600.” Elmiron capsules contain 100 mg of the following:

  • Pentosan polysulfate
  • Gelatin
  • Magnesium stearate
  • Microcrystalline cellulose
  • Titanium dioxide

What Class Drug Is Elmiron?

Elmiron is what’s known as a urinary analgesic. This class of medication helps alleviate any pain and irritation in the urinary tract or bladder. Elmiron also has some anticoagulant characteristics, and it can increase your chance of bleeding, according to a Food and Drug Administration (FDA) drug fact sheet.

What Is Elmiron Medicine Used For?

Elmiron’s most important ingredient is pentosan polysulfate. Despite this being Elmiron’s key ingredient, experts say they don’t completely understand how pentosan polysulfate works. It is believed the ingredient shields the bladder from irritants in the body’s urine. 

Pentosan polysulfate does not stop inflammation like other pain relief drugs. People suffering from IC have a damaged bladder wall. This wall normally protects the bladder from the effects of foreign contaminants. Without this protective wall intact, people experience pain and discomfort from these irritants in the bladder.

Simply put, Elmiron coats the lining of the bladder wall, blocking these irritants from causing these effects.

Elmiron Side Effects

Side effects are common in pharmaceutical drugs. For context, a side effect is an additional reaction from a drug or medication. These side effects are usually unwanted and exist due to taking the drug or medication to relieve symptoms.

If you are reading this and have experienced side effects from Elmiron, talk to your doctor right away. Users are cautioned against stopping any prescribed medication without first discussing it with their doctor.

One common side effect Elmiron users report is bruising. Because Elmiron is a blood thinner, you may experience frequent bruising. Other Elmiron side effects include:

  • Abnormal liver function tests
  • Blood in the stool
  • Bruising
  • Diarrhea
  • Dizziness
  • Hair loss
  • Headache
  • Nausea
  • Rash
  • Upset stomach

Elmiron Eye Side Effects and Pigmentary Maculopathy

A more serious side effect of Elmiron is pigmentary changes, known as pigmentary maculopathy. This symptom happens to longtime users of the drug. At this point, researchers are unsure of the causes. Victims report having difficulty adjusting to low lighting conditions, blurry vision, and trouble reading. Contact your doctor immediately if you are a regular Elmiron user and notice any of these symptoms. 

Pigmentary maculopathy has been linked to patients losing their vision completely or suffering from vision damage. Most vision loss or damage is typically tied to using the drug for three or more years. However, some patients have reported vision problems after using Elmiron for a shorter time. 

The FDA also warns consumers of Elmiron’s potential to cause retinal pigmentary changes. The warning specifies that pigmentary maculopathy occurs most often with long-term Elmiron use. If you have a history of retina problems, you are strongly urged to discuss your history with your health care providers. 

Is It Safe to Take Elmiron?

With serious side effects like pigmentary maculopathy, Elmiron may not be safe for you to take. Seek advice from your doctor as soon as possible to discuss your options and possible alternatives for your interstitial cystitis.

How Should I Take Elmiron?

Elmiron prescriptions specify 300 mg per day. The instructions tell patients to take three 100-mg capsules three times each day. Take Elmiron with water at least an hour before each of your three meals. You may also take Elmiron at least two hours after your meals.

If you miss a dose of Elmiron, Mayo Clinic recommends taking the medication as soon as possible when you realize you missed the original time frame. However, you should skip the dose if you are close to the time frame for your next dose.

You should not take double the dose of Elmiron. Although the medicine label from the FDA indicates no reports of Elmiron overdose, the label does recommend stomach pumping (gastric lavage) for acute overdoses.

Length of Prescription

Your health care provider may prescribe for you to take the drug for 90 days. After that time, they may ask to evaluate you for any IC improvement and check to see if you have any mild or severe side effects. If you do not have any serious side effects but also see that your IC has not improved, your doctor may recommend you take another 90-day supply of Elmiron. 

Elmiron Warnings and Precautions Before Taking This Medication

Elmiron prevents blood clotting, but its strength is considerably weaker than heparin, a blood thinner. At one-fifteenth strength, Elmiron is considered a weak anticoagulant. 

Before taking Elmiron, patients should discuss their medical history with their doctor. If you have a history of any of the following, Elmiron may not be the best option for you:

  • Blood vessel disorders, including aneurysm
  • Hemophilia, thrombocytopenia, and other bleeding disorders
  • Liver disease
  • Stomach or intestinal disorders, including diverticula, stomach ulcers, or polyps
  • Spleen disorders

Other serious medical considerations or things to avoid while taking Elmiron include:

Bleeding Disorder Cautions

Before taking Elmiron, discuss any history of bleeding disorders you may have had. If you are taking drugs that may increase bleeding, you must notify your healthcare providers before any scheduled surgeries.

Some of these drugs or medications may include:

  • Blood thinners
  • Aspirin
  • Non-steroidal anti-inflammatory drugs (NSAIDs)

Elevated Liver Enzyme Cautions

Some research shows certain patients using Elmiron exhibit elevated liver enzymes after starting treatment. These users report liver enzyme issues from three months to an entire year after starting Elmiron treatment. 

Research has not yet begun on Elmiron users who have liver insufficiency. If you suffer from liver insufficiency, proceed with extreme caution when using Elmiron. Discuss your medical history with your doctor thoroughly to make an informed decision on whether you should take Elmiron. 

Using Elmiron While Pregnant or Breastfeeding

Persons who are pregnant or may become pregnant may use Elmiron, but only if they have a definitive need for it, as per Elmiron’s label. There have been laboratory studies on pregnant rats and mice with Elmiron. These studies did not reveal any problems with the test animals;’ fertility or harm to the unborn rodents.

However, lab studies with mice and rats do not always predict how human beings will respond to a drug. As of this writing, no one has conducted extensive tests on pregnant women with Elmiron. 

If you have recently given birth and are nursing, use caution when using Elmiron. Some drugs are known to pass through breast milk., At this time, it is unknown whether Elmiron is excreted through breast milk. 

Drug Interactions with Elmiron

Elmiron’s labels and inserts do not list any drug interaction cautions at this point. Patients are nonetheless cautioned to always discuss any medications they may be taking. Because Elmiron is a mild blood thinner, users may be at a higher bleeding risk. 

What Happens if I Overdose on Elmiron?

If you overdose, the FDA recommends gastric lavage be performed. Gastric lavage is the process of removing toxic contents from the stomach via a tube. The procedure is also known as stomach pumping. 

Elmiron and Interstitial Cystitis (IC)

Many people suffering from interstitial cystitis wonder if Elmiron will cure their condition. While the drug does not cure IC, it relieves symptoms for its users. As of 2022, there is no cure for IC.

Medical experts do not yet know what causes the condition. Some people report IC flareups at specific times. Some IC flareups have been linked to:

  • Stress 
  • Certain foods and drinks
  • Withholding urine
  • Wearing tight underwear or undergarments

Symptoms of Interstitial Cystitis

If you suffer from any of the symptoms listed below, talk to your doctor about getting tested for IC. Ask yourself these questions to determine if you need to schedule an appointment with your doctor:

  • Does your bladder, pelvic area, or lower abdomen feel tender?
  • Do you feel pain in the above areas?
  • Do you have to urinate several times a day?
  • Do you wake up with the need to urinate often in the middle of the night?
  • Do you feel increasing pain until you empty your bladder?
  • Do you feel pain during or after you have sexual intercourse? 

What Does Elmiron Do to Your Eyes?

Researchers at the Emory Eye Center at Emory University Medical School in Atlanta have uncovered a potential link between Elmiron and retinal maculopathy. These scientists noted that Elmiron users between 2015 to 2017 were more likely to develop retinal maculopathy.

These patients reported several visons issues, including trouble reading and having trouble adapting to low-level lighting situations. While no hard conclusions are available currently, the outlook for Elmiron does not look promising. Researchers recommend that Elmiron users with vision problems stop taking the drug.

Elmiron Recall

Despite growing evidence that seems to suggest Elmiron causes eye damage and even permanent vision loss, the product has not yet been recalled. It is currently still on the market as an FDA-approved drug. 

What to Do if You Suffered Eye Damage

If you feel Elmiron has caused you to suffer vision loss or damage, contact your doctor immediately. While no direct substitute for Elmiron exists, your healthcare provider could suggest a different solution for you. The most important thing you can do is try to mitigate further injury. 

Elmiron Alternatives

IC is a chronic disease with no cure. No treatment regimen will work for everyone. Medical experts have culled a list of possible treatments to help IC patient reduce their discomfort through natural or lifestyle changes. Discuss the suggestions below with your doctor. 

Many people suffering from IC find that a combination of techniques may be necessary to provide enough relief. Doctors also mentioned that surgery can be considered as a last resort if none of the alternatives below work.

Because no medication exists that can replace Elmiron, medical experts suggest the following:

  • Water: Drink plenty of water to stay hydrated. Distending the bladder with water may relieve some of the pressure.
  • Stop smoking: If you use tobacco products, stop immediately.
  • Exercise: Getting active can help relieve some IC symptoms
  • Physical therapy: This form of therapy can reduce pain and improve your function and mobility.
  • Over-the-counter pain relievers: These medications can reduce inflammation, pain, and swelling, among other conditions.

Experts also recommend avoiding the following substances, as they have been known to make IC symptoms worse:

  • Carbonated beverages 
  • Caffeine
  • Citrus
  • Vitamin C

By trying these, you may be able to lessen some of the discomfort associated with your IC.

Lawsuits Filed Against Elmiron Manufacturer

If you have been taking Elmiron for at least two years through a doctor’s prescription, you can pursue a lawsuit. Litigation against Elmiron manufacturer Janssen Pharmaceuticals, Inc., is still in its early stages; as of May 16, 2022, 1,034 cases are pending in New Jersey courts. The first bellwether trials are scheduled, with the first to begin sometime early in 2023, according to Case Management Order 9. 

Since there are no completed cases or awards as of May 2022, we can only discuss compensation we could try to pursue in an upcoming Elmiron lawsuit.

The kinds of compensation you may qualify for will depend on the specifics of your claim. No two cases are exactly alike, and no outcome is guaranteed. However, if you are eligible, you may receive compensation for economic and non-economic damages. 

Economic Damages

Any direct financial cost to you is an example of economic damage. Any medical treatment stemming from eye problems Elmiron caused would be in line for compensation. These expenses may include:

  • Doctor’s visits
  • Medications
  • Physical therapy
  • Ongoing medical costs

Economic damages also include lost earnings. If you cannot return to work while undergoing treatment for any Elmiron-related eye injuries, you may receive compensation. This includes compensation for future lost wages if you cannot return to work. 

Non-Economic Damages

Not all compensation is based on finances. Non-economic damages are those that cannot be tied to direct financial loss. Some forms of non-economic damages include:

  • Pain and suffering
  • Loss of enjoyment of life
  • Emotional duress
  • Psychological trauma

It can be difficult to set a dollar amount for some of the above damages. But as the victim of another person or entity’s negligence, you deserve to be compensated for your losses.

Punitive Damages

The third form of damages may be awarded in certain cases. If your lawsuit proceeds to court and a jury hears it, it may award you punitive damages. These damages are not awarded in every plaintiff product liability case victory.

If a jury thinks the company responsible for your injuries was especially negligent, you may receive additional damages to punish the defendant. These damages intend to persuade the defendant to never again repeat their behavior.

Conduct a Product Liability Law Firm

Our network of personal injury and mass tort attorneys helps victims of defective products seek justice for their cases. Unfortunately, many mammoth corporations behave as if they are above the law. They release harmful products they know are dangerous in the name of profits. 

You should not have to fight for financial recovery from Elmiron use alone. Fill out our contact form today to learn more about how we can help with your case.