ROSENBAUM & ROSENBAUM, P.C. | March 4, 2021 | Products Liability
According to the Centers for Disease Control and Prevention, up to 12% of women in the U.S. may have early symptoms of interstitial cystitis. Interstitial cystitis (IC) is a chronic bladder condition that only gained the attention of medical researchers within the last several decades. The first population-based study on IC was pioneered in 1975.
With such sparse research on the condition, prescription drug manufacturers have struggled to develop medications to safely treat IC. Doctors have struggled to reach an agreed-upon definition due to:
- A lack of specific diagnostic criteria for IC
- The lack of histopathologic changes
- The unpredictable changes in symptoms, including cyclical severity
- The extreme variability of symptoms, objective findings, and treatment response
In part, the condition’s disparate presentations in women and men have contributed to the confusion. Only 10% of IC patients are men.
How Is IC Treated?
Before treating IC, doctors first have to diagnose IC. This can be hard since the condition lacks a consensus on diagnostic criteria. Some generally-accepted symptoms of IC include:
- Mild discomfort in the abdomen or pelvis
- Frequent urination
- Feeling of urgency to urinate
- Feeling of pressure in abdomen or pelvis
- Tenderness or intense pain in the bladder or pelvic region
- Severe lower abdominal pain that sometimes worsens as the urinary bladder fills or empties
Doctors may also order tests like pelvic exams, urine tests, or biopsies to help them make their diagnosis.
There is no commonly-accepted treatment for IC. Some treatment methods include medications, nerve stimulation procedures, and surgery.
What’s Wrong With Elmiron for IC?
The medication Elmiron is one method of treatment for IC. Elmiron works by forming a layer on the cells of the bladder wall to prevent irritation caused by chemicals in urine.
Elmiron is intended to improve symptoms of bladder inflammation, pelvic pain, and irritation. In some IC patients, the pain level of these symptoms can range from moderate to severe.
Researchers have linked a component in Elmiron called a Pentosan Polysulfate Sodium (PPS) to increased risk for the eye disease, pigmentary maculopathy, known to cause blindness.
Specifically, the research found that patients with increased exposure to PPS were more likely to struggle with reading small print and to report a diagnosis of macular disease.
What Are the Symptoms and Side Effects Associated With Elmiron?
There are numerous symptoms and side effects associated with Elmiron, many of which are disclosed in Elmiron’s patient information document required by the U.S. FDA:
- Hair loss
- Abdominal pain
- Upset stomach
While patients should have been informed of the risks of these side effects, patients were not aware of the increased risks of vision loss.
How Does Elmiron Cause Blindness?
Researchers do not yet have a good understanding of how Elmiron increases the risk of vision loss, or even whether Elmiron alone causes the vision loss. Correlation, as they say, does not equal causation. But there are not many other causes in consideration right now.
Doctors do know that patients who took PPS consistently were the ones that suffered from pigmentary maculopathy. The injury occurs in the cell layer of the retina.
Doctors do not yet know how much Elmiron a patient must take before suffering vision loss. However, they do recommend that patients get an annual scan for retina damage unless toxicity symptoms indicate a sooner scan. Patients who suffer other side effects should consult with their doctors.
What Can I Do If I Took Elmiron and Am Suffering Vision Loss?
Personal injury lawyers in New York City and across the country are taking on clients as part of what’s called “mass tort” litigation. These lawyers are fighting for Elmiron injury victims who have suffered vision loss after exposure to PPS.
If you took Elmiron and are suffering vision loss, reach out to a reputable personal injury attorney to learn more about your legal rights.