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Studies Tie Elmiron to Eye Damage and Vision Loss

Dr. Nieraj Jain at the Emory Eye Center in Atlanta, Georgia first suspected that prolonged use of Elmiron to treat interstitial cystitis, also called painful bladder syndrome, could be damaging the retinas of some patients. Using advanced retinal imaging, he found that six Emory Eye Center patients, all women who had been taking Elmiron for IC, had eye damage doctors had never seen before. Calling these symptoms “retinal maculopathy,” the doctors found the pigment cells within these women’s retinas literally had changed color.

Ophthalmologists in northern California then began to review the histories and health of their patients who had been taking Elmiron. They found that about 25 percent of patients with significant exposure to Elmiron showed signs of eye damage.

Elmiron is one of only two drugs approved by the FDA to treat interstitial cystitis.

What Is Pigmentary Maculopathy?

The retina is a thin layer of tissue located at the back of the eye. It contains millions of tiny light-sensing nerve cells commonly called “rods” and “cones” because of their shapes.

Cones are found at the center of the retina in an area called the macula. Cones provide sharp clear vision in bright light, detecting colors and details. Rods are located outside the macula and extend to the edge of the retina. Rods handle peripheral (side) vision; they also detect motion and help us see in dim light.

When examining Elmiron patients with eye damage, doctors have found changes in the maculae. Vision changes and complaints reported by these patients include:

• Having difficulty reading
• Difficulty adapting to dim lighting
• Blurred vision, often in the center of their field of vision
• Dark spots in the center of vision
• Difficulty seeing objects up close
• Seeing colors as muted, less-vivid than usual
• Seeing straight lines as curved

Before the link to Elmiron was discovered, these vision problems and eye injuries may have been misdiagnosed as:

• Age-related macular degeneration
• Pattern dystrophy

However, physicians and researchers have now identified a unique and discernable pattern of injuries in Elmiron patients with eye damage and named it “pigmentary maculopathy.”

Doctors have found that, when caught early, the pigmentary maculopathy damage may be mitigated by stopping the medication. [Warning: Never stop taking a prescribed medication without consulting your physician.] However, if the pigmentary maculopathy remains undiagnosed and the patient continues taking Elmiron, the injuries can lead to permanent vision loss.

Now that the medical community knows of the relationship between eye injuries/retinal damage and Elmiron (pentosan polysulfate sodium), doctors recommend patients taking Elmiron should receive eye exams at least annually.

Elmiron, or Pentosan Polysulfate Sodium (PPS)

Elmiron is one of only two drugs the FDA has approved to treat IC. Elmiron’s listed common side effects are:

• diarrhea
• nausea
• stomach upset or pain
• abdominal pain
• headache
• hair loss
• dizziness
• itching or skin rash

Previously known, more serious but less likely, side effects of Elmiron include:

• unusual bruising or bleeding (including blood in your stool),
• mental/mood changes or depression
• discomfort when swallowing
• heartburn

Anyone taking Elmiron who experiences any of these more serious side effects should immediately report them to their doctor.

The FDA has now added eye disorders to its list of Potential Signals of Serious Risks for Elmiron (PPS) and is reportedly evaluating the need for regulatory action concerning Elmiron and eye injuries and vision damage.

If you or a loved one took Elmiron to treat interstitial cystitis (IC) and developed vision problems and experienced damage to their retinas, contact us for a free consultation.