Pentosan Polysulfate Sodium (brand name Elmiron) is a type of carbohydrate derivative drug used to treat an incurable urinary condition called interstitial cystitis or bladder pain syndrome. The first product liability Elmiron lawsuit was filed in March 2020, alleging that long-term exposure to the drug is potentially linked to maculopathy – an eye disorder of the retina that often causes blindness.
Showard Law Firm is reviewing cases of patients who believe they may have been harmed by their routine use of Elmiron.
Elmiron and bladder pain
An estimated 4 to 12 million Americans may be suffering from frequent and urgent urination, persistent pain, ulcers, sleep disturbances, and symptom flare-ups. Since 1996, doctors have prescribed Elmiron for the improvement of bladder and pelvic symptoms associated with interstitial cystitis. Most patients take three 100 mg doses per day for at least three to four weeks, but some patients do not see improvement until six to nine months on the drug. Some patients have taken the drug for years or even decades. Doses up to 1,500 mg may be prescribed for severe flare-ups.
Dangerous Side Effects
Long-term Elmiron users have experienced symptoms of retinal maculopathy, such as:
- Blurry vision
- Difficulty reading, particularly in dim light
- Dark spots in the center of vision
- Colors appearing duller than normal
- Straight lines appearing curved
Patients are sometimes misdiagnosed as having age-related macular degeneration or retinal pigmentary endothelium injury. Similar to macular degeneration, this rare form of pigmentary maculopathy of unknown etiology alters pigment cells in the retina. Patients present with yellow lesions below the macula, epithelium atrophy, and hyperpigmented spots on the retina.
If undetected, maculopathy can cause blindness.
Six patients presented with pigmentary maculopathy following long-term exposure to Elmiron for interstitial cystitis, according to the Emory Eye Center’s findings published in the American Academy of Ophthalmology journal in 2018. By 2019, 10 patients had been identified.
Kaiser Permanente clinicians examined their 4.3 million patient database and found that pentosan polysulfate sodium caused retinal damage in about 25% of patients. Toxicity rose 11% in patients taking 500 to 1,000 grams and 42% with those taking 1,500 grams or more.
Researchers recommended annual eye screenings for all patients taking Elmiron. Patients with signs of retinal damage should consult their doctors about discontinuing the medication, they added.
Other Adverse Elmiron Side Effects
Possible Elmiron side effects listed on the product label include:
- Abdominal discomfort
- Abnormal liver function tests
- Blood in the stool
- Hair loss
- Upset stomach
Side effects range from person to person but are generally mild and transient. The warning label does not mention any eye-related symptoms – which is the reason why patients might consider an Elmiron lawsuit. Most people would think twice before taking a drug that could potentially cause vision disturbances and blindness.
- Oct 1996: The FDA approves the 100 mg oral dose of Elmiron to treat interstitial cystitis.
- May 2018: Emory Eye Center uses the term “retinal maculopathy” for pigment cell degeneration.
- April 2018: Emory Eye Center recommends that patients with eye damage stop taking Elmiron.
- Oct 2019: Kaiser Permanente finds 24% of Elmiron users have retinal maculopathy.
- Nov 2019: Dr. Neiraj Jain found pentosan users had a high risk of macular disease after seven years.
- Dec 2019: IC Network finds 53.87% of 1,604 Elmiron users reported retinal disease.
- Jan 2020: Doctors Vora, Patel, and Melles found 27 of 117 patients with IC who took PPS had toxicity.
Elmiron is manufactured by Janssen Pharmaceutica, a division of Johnson & Johnson headquartered in Beerse, Belgium. Despite finding optic neuritis and retinal hemorrhage in clinical trial patients, the company never added any warnings to the label or conducted further research to determine why some patients experienced adverse eye effects or how the risk could be reduced.
Should You File an Elmiron Lawsuit?
If you’ve taken Elmiron for at least two years and suffered vision problems while taking the drug or within two years of stopping treatment, you may qualify to file a lawsuit. Once you’ve spoken with your general practitioner and an eye doctor, speak with a lawyer at Showard Law Firm. You have a limited amount of time from the discovery of the injury to pursue legal action based on the state where you reside.
Elmiron Lawsuit Settlement Amounts
The first Elmiron lawsuit was filed in March 2020. To date, there have been no settlements or jury verdicts. Given the high number of prescriptions written, we anticipate many more lawsuits to be filed. Similar lawsuits may be combined into MDL (multidistrict litigation) proceedings to streamline early discovery before each case goes to individual trial.
It’s not uncommon to see dangerous drug cases result in multi-million-dollar settlements or awards. If you or a loved one have suffered vision loss after taking Elmiron, it’s important to find out if your medication was a factor, as you may qualify for compensation that will cover your medical bills, lost wages, and pain and suffering. Showard Law Firm has experience successfully representing dangerous drug cases nationwide. Call us today for a no-cost, no-obligation consultation.