Elmiron Eye Injuries – Updated Drug Label Warns of Possible Elmiron Vision Risks

Elmiron® Background

Janssen Pharmaceuticals, Inc. makes a drug called, Elmiron. The chemical compound is Pentosan Polysulfate Sodium. It is a carbohydrate derivative (modified sugar molecules). It is a white, odorless powder in its natural form.

Doctors typically prescribe this drug to treat a urinary condition called interstitial cystitis, or bladder pain syndrome (BPS). This is a “chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain.” It affects men and women, although women more often.

Physicians prescribe Elmiron to relieve moderate to severe pain. Patients may suffer from abdominal, pelvic or genital pain. Additional symptoms could include frequent urination and a continual feeling of urgency to urinate.

Elmiron® market timeline

The FDA approved Elmiron in September 1996. A drug’s label includes important information about the product. This includes warnings about risks. Elmiron’s label changed in 2001, 2004, 2006, twice in 2008, and on June 16, 2020.

Janssen changed the Elmiron® label regarding potential Elmiron vision risks on June 16, 2020

KBA wrote about the risks concerning Elmiron over a year ago. Our piece noted that Elmiron could precipitate significant side effects and serious complications. On June 24, 2019, Janssen Pharmaceuticals, Inc. submitted a Supplemental New Drug application (sNDA) to FDA. It sought to revise “the package insert WARNINGS section and PostMarketing section, as well as an update to the Patient Labeling.”

The new label includes a warning section, Retinal Pigmentary Changes. It notes that “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON®.” It explains this is after long term use. “Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.” The risk involves “difficulty reading, slow adjustment to low or reduced light environments, and blurred vision.” This label change reacts to years of research suggesting a link between vision problems and Elmiron. Notwithstanding this label change and warning, it is important to speak with your physician about the product and to not stop taking a drug without medical advice and supervision.

Potential Elmiron® risks and side effects

A peer-review journal noted last year that chronic use of pentosan polysulfate sodium was associated with risk of vision-threatening disease. Researchers in February 2020 wrote about possible vision-threatening maculopathy secondary to Elmiron. They conducted a multicenter screening study of patients with IC/BPS. Doctors sometimes diagnosed these as other conditions. For example, one group of authors presented a case of pentosan polysulfate maculopathy originally diagnosed as stargardt disease. 

Given all this, Plaintiffs have filed lawsuits.

Common symptoms for patients experiencing this Elmiron®-associated eye damage are:

• Difficulty reading
• Difficulty adapting to dim lighting
• Blurred vision (often centrally in the patient’s field of vision)
• Dark spots in center of vision
• Straight lines appearing curved or squiggly
• Muted, less vivid colors

Although considered rare, Elmiron may cause significant, possibly permanent vision problems. Patients should speak with their doctors and seek legal advice if they have injuries.

Relatively common side effects that vary from person to person may include:

• Nausea
• Diarrhea
• Indigestion
• Abdominal discomfort
• Headaches
• Hair loss

These issues are often mild and transient. They are listed in the product label.

Some doctors suggest anyone using the drug undergo a full eye exam regardless of whether symptoms are present. Additionally, some doctors caution patients with interstitial cystitis who also have eye degenerative issues to find another treatment option. The point is, talk to your doctor if you have used Elmiron. As discussed in the next section, it is critical to speak with your physician.

Talk to your Doctor

We are not medical professionals. This information is just that, information. It is not a recommendation. Not all people are at risk and the drug is not the only cause of these symptoms or conditions. Do not stop taking the medication without consulting your physician.

Contact KBA to Discuss Potential Legal Options

If you used Elmiron for years and have vision problems, KBA Attorneys might be able to help. Our team of lawyers have experience trying drug cases. For more information, contact us today