Elmiron’s manufacturer Janssen Pharmaceuticals is being sued for failing to warn patients and healthcare professionals that the drug may cause retinal pigmentary maculopathy, which may lead to blindness. Aside from vision problems, Elmiron may cause several side effects including hair loss, bloody stools, and liver problems.
Shouse Law Group is bringing Elmiron lawsuits against Janssen Pharmaceuticals on behalf of patients who developed vision impairment after taking the drug. We are pursuing the highest financial settlement possible to cover our clients’ medical bills, lost wages, lost earning capacity, and pain and suffering.
In this article, our Elmiron attorneys discuss:
- 1. What are Elmiron’s side effects?
- 2. Is pigmentary maculopathy a side effect?
- 3. What does Elmiron treat?
- 4. Is taking Elmiron worth the risks?
1. What are Elmiron’s side effects?
Elmiron’s most common side effects include:
- hair loss (alopecia),
- diarrhea and accompanying abdominal pain,
- blood in the stool,
- upset stomach,
- abnormal liver function tests,
- dizziness, and
The drug’s packaging says, “Call your doctor if any of these side effects persist or are bothersome or if there is blood in your stool.”
According to a clinical trial of nearly 2,500 patients, less than one percent of people experienced the following abnormalities while taking Elmiron:
- mouth ulcer,
- gum hemorrhage,
- increased prothrombin time,
- increased partial thromboplastin time,
- allergic reaction,
- optic neuritis,
- amblyopia, and/or
- retinal hemorrhage 1
2. Is pigmentary maculopathy a side effect?
Currently, pigmentary maculopathy is not listed as a side effect on Elmiron’s packaging. Instead, it is listed under WARNING: Retinal Pigmentary Changes. The warning label pamphlet distributed with Elmiron says the following:
Pigment changes in the retina of the eye (also referred to as pigmentary maculopathy in medical journal articles) have been reported with long-term use of ELMIRON®. While the cause of the pigmentary changes is unclear, continued long term dosing with ELMIRON® may be a risk factor. The consequences of these pigmentary changes in the retina are not fully understood. Visual symptoms that have been reported include: difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. If you already have retinal pigment changes from other causes, it may be difficult to distinguish future retinal pigment changes if they occur. Call your doctor (including your eye doctor) if you notice any changes in your vision. Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes. Your doctor will discuss with you when to get your first eye examination and follow up exams, and whether the treatment should be continued since these changes may be irreversible and may progress even after stopping treatment.2
The increasing number of lawsuits against Janssen Pharmaceuticals suggests that pigmentary maculopathy may very well be a common and serious side effect. But at this time, the drug maker refuses to admit this.
3. What does Elmiron treat?
Elmiron (pentosan polysulfate sodium) is a prescription drug administered to provide relief to patients suffering from interstitial cystitis (IC or painful bladder syndrome). This is a bladder condition where the person constantly feels the urge to urinate or has trouble urinating. IC is often accompanied by bladder pain and a burning sensation of the bladder wall.
Many IC patients are initially misdiagnosed as having a urinary tract infection (UTI). Since IC is not an infection, it does not respond to antibiotics as UTIs do.3
4. Is taking Elmiron worth the risks?
This is a personal decision that each patient should make with his/her physician. Interstitial cystitis is agonizing, so some people think the hope Elmiron offers is worth the aforementioned side effects and eye problem risks. But there are many other ways to try to manage IC without Elmiron. These include:
- Nonsteroidal anti-inflammatory drugs (nsaids), such as ibuprofen or naproxen sodium
- Anti-histamines, such as loratadine and hydroxyzine
- Tricyclic antidepressants, such as amitriptyline or imipramine
- Changing diet to minimize acidic foods and other irritating substances
- Bladder training (urinating on a schedule rather than when the urge hits)
More invasive treatments include transcutaneous electrical nerve stimulation (TENS) and/or sacral nerve stimulation.4
In short, IC patients may wish to ask their healthcare provider for medical advice about other options before resorting to Elmiron.