Elmiron

Pentosan polysulfate sodium–better known by the trade name Elmiron–is used to treat interstitial cystitis (IC). Elmiron is one of only two FDA-approved therapies for IC. Although widely prescribed for decades, researchers have recently discovered a possible link to ocular toxicity and vision side effects. Doctors have been warning about Elmiron vision problems since 2018. In 2020, the FDA approved updates to Elmiron’s safety labeling to reflect the risk of changes in the retina.

A growing consensus of doctors now agrees that patients exposed to pentosan polysulfate sodium (PPS) have an increased risk of developing a unique type of maculopathy. If you are taking Elmiron and have concerns about your vision, you should speak to your doctor. You may also want to consider speaking to a lawyer about an Elmiron lawsuit. Sanders Phillips Grossman is offering complimentary legal consultations to Elmiron patients suffering from vision problems. Click here to receive a free case review.

What is the drug Elmiron used for?

Elmiron is a doctor-prescribed treatment for interstitial cystitis. Sometimes referred to as painful bladder syndrome, interstitial cystitis causes pain and discomfort in the bladder and pelvic region, urinary frequency, and dyspareunia (pain during intercourse). Patients with interstitial cystitis may also experience disrupted sleep, social isolation, and emotional distress. Interstitial cystitis predominately affects women, but men are also diagnosed. An estimated one million women may suffer from IC, according to Janssen Pharmaceuticals, the company that makes Elmiron.

There are only two FDA-approved drugs for IC treatment: dimethyl sulfoxide and Elmiron (pentosan polysulfate sodium). Elmiron is taken orally, while dimethyl sulfoxide is taken intravenously. The recommended dosage is one Elmiron 100 mg capsule taken three times per day. Janssen Pharmaceuticals promotes Elmiron as “the only oral medication that is FDA approved to treat the bladder pain or discomfort associated with IC.”

Elmiron has been used to treat IC for more than two decades. It was first prescribed to patients through the FDA’s “compassionate use,” or expanded access program. The FDA approved Elmiron in 1996. Doctors estimate that Elmiron has been prescribed to hundreds of thousands of IC patients.

Does Elmiron cure interstitial cystitis?

There is no known cure for IC. However, Elmiron may relieve the symptoms of IC.

The Elmiron patient brochure notes that users can expect gradual symptom relief over 3 to 6 months. Some patients report symptom relief in as little as 3 to 4 weeks. In addition to drug therapy, diet and lifestyle choices are recommended for IC patients. For example, certain foods may make symptoms worse, such as and drinks containing caffeine or alcohol, processed foods, spicy foods, acidic foods, and products containing artificial sweeteners or MSG.

The efficacy of Elmiron for treating IC is disputed. Some studies show that Elmiron benefits around 1 out of 3 patients. Research in the Journal of Urology found that pentosan polysulfate sodium was not more effective than a placebo at treating IC symptoms.

How Does Elmiron Work?

Janssen states that it is not known exactly how Elmiron works to treat IC. The Interstitial Cystitis Association explains that Elmiron is thought to work by bonding to the bladder’s surface, which is composed of a glycosaminoglycans, or GAG layer. This mucus coating protects the bladder wall from bacteria and irritating substances in urine. Elmiron may act as a synthetic GAG layer that binds to the bladder’s lining and restores a damaged, thin, or “leaky” bladder surface, but the drug’s actual mechanism of action in IC is unknown.

What are the side effects of Elmiron?

Elmiron is a weak anticoagulant (blood thinner) drug which may increase bleeding. Serious side effects were reported in around 1.3% of patients during Elmiron clinical trials. According to prescribing information, the most common side effects of Elmiron are:

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

These symptoms were reported in approximately 1% to 4% of patients during clinical trials. Less common side effects (reported in less than 1% of trial participants) include:

  • Vomiting
  • Mouth ulcers
  • Esophagitis
  • Gastritis
  • Constipation
  • Anemia
  • Pruritus (itch)
  • Urticaria (hives)
  • Conjunctivitis
  • Tinnitus
  • Optic neuritis
  • Retinal hemorrhage

Elmiron Vision Problems

Recently, a new type of Elmiron side effect affecting the eye was discovered. No eye-related adverse events were reported during clinical trials. It wasn’t until 2018 that doctors began describing a type of progressive eye disease called maculopathy that is associated with long term Elmiron use. Maculopathy affects a part of the eye in the back of the retina called the macula. Doctors call the Elmiron-related maculopathy a “novel” maculopathy because it is a new condition that does not resemble any previously described maculopathy.

While they aren’t quite sure how this type of maculopathy develops, scientists believe that long term use of Elmiron is a risk factor. In one study of the disease, patients with maculopathy had been taking Elmiron from 3 to 22 years, with a median duration of around 15 years. Scientists have suggested that over time, toxins from the drug may build up in the body and damage the eye.

The most common symptoms of Elmiron-related maculopathy include:

  • Blurred vision
  • Vision loss
  • Diminished night vision
  • Slow adjustment to low or reduced light conditions
  • Trouble focusing
  • Difficulty reading
  • Changes in eye color pigment

Patients with symptoms of Elmiron-related maculopathy have been filing lawsuits against Janssen for failing to warn about these vision problems. Learn more about Elmiron lawsuits.

Can Elmiron cause blindness?

Yes, it is possible for Elmiron to cause blindness. Research suggests that this type of maculopathy gets worse over time and causes vision loss. Other types of maculopathy don’t cause total blindness, but the condition can lead to blind spots and loss of central vision (even though peripheral vision is retained). If a person loses enough of their central vision, they may be classified as “legally blind.”

It is not yet clear whether discontinuing Elmiron halts or alters the development of maculopathy. If you experience vision changes such as difficulty reading, slower adjustment to low or reduced light, or blurred vision, call your doctor to discuss the issue. Eye imaging examinations may be needed for an accurate diagnosis.

Is there an alternative to Elmiron?

One other FDA approved treatment is available for IC patients. Dimethyl sulfoxide (DMSO) is an anti-inflammatory drug that may reduce swelling and pain due to interstitial cystitis and improve blood supply to the treated area. DMSO sold under the trade name Rimso-50 was approved by the FDA for IC treatment in 1978. It is administered into the bladder through a temporary catheter. The treatment is often given weekly for six to eight weeks or longer.

DMSO is not associated with vision problems, but the American Urological Association (AUA) IC guidelines say that, “No single treatment has been found effective for the majority of patients.” Your doctor may also recommend treatments for IC that have not been specifically approved by the FDA for this use. Combination therapy (a mix of different therapies) might be used. You can view AUA treatment guidelines here.

You should never make a decision about your medication without first speaking to your doctor. Any patient diagnosed with Elmiron-related maculopathy should consider consulting with an attorney as well. You might have a case against Janssen if you took Elmiron for two or more years and were diagnosed with eye problems related to the macula or retina, such as macular degeneration or pigmentary maculopathy.

Lawsuit Update: MDL Issued for Elmiron Lawsuits Alleging Drug Causes Eye Damage, Vision Loss