Studies have demonstrated that significant exposure to Elmiron is linked to eye damage resulting from medication toxicity. Hundreds of patients who took the bladder medication on a long-term basis have been diagnosed with severe eye problems. These include macular degeneration, blurred vision, pigmentary maculopathy, and retinal injury.
If you took Elmiron and developed vision impairment or other serious side effects, you may be eligible for legal compensation. Showard Law Firm understands the complexities of product liability law and has successfully handled dangerous drug lawsuits for over a decade.
We have the experience and resources to pursue the compensation our clients deserve after suffering complications from Elmiron.
Common side effects of Elmiron
Side effects of prescription pharmaceuticals can be life-altering, placing tremendous financial burdens on victims. Elmiron, produced by Johnson & Johnson subsidiary, Janssen Pharmaceuticals, has been available to consumers since 1996. The drug is approved to treat the pressure and discomfort caused by interstitial cystitis, a bladder disorder.
Drug manufacturers have a duty to include sufficient warnings on the label and prescribing information about potential side effects and complications. The Elmiron product label states the most common side effects from pentosan polysulfate sodium include:
- hair loss
- headache
- nausea
- abdominal pain
- dizziness
- rash
- blood in the stool
- abnormal liver function tests
- bruising
- insomnia
- weight gain and swelling caused by fluid retention
Adverse reactions linked to Elmiron
According to the Elmiron prescribing information leaflet, serious adverse events and reactions observed in unblinded clinical trials occurred in a mere 1.3 percent of patients.
These complications included:
- Colitis
- Mouth ulcers
- Anorexia
- Gastritis
- Pharyngitis
- Dyspnea
- Gum hemorrhage
- Tinnitus
- Optic neuritis
- Retinal hemorrhage
- Thrombocytopenia
- Leukopenia
- Pelvic pain
- Vaginitis
Unfortunately, Elmiron’s manufacturer did not list any warnings about possible eye damage, disease, or vision loss with prolonged exposure. The only vision-related complications listed in the patient leaflet are lazy eye, conjunctivitis, optic neuritis, and retinal bleeding. However, these are listed as extremely rare adverse events.
Plaintiffs in Elmiron lawsuits claim that this misrepresentation and omission of potential complications exposes Janssen Pharmaceuticals to liability. Holding drug manufacturers accountable for their actions– especially pharmaceutical titans like J&J– is difficult work, but Showard Law Firm is up to the task. Our firm has handled numerous mass torts involving defective drugs and is prepared to advocate for your rights.
Elmiron and retinal injury
A 2019 study at Emory raised additional concern about the connection between Elmiron and long-term eye damage. The researchers presented their findings at the American Urology Association Annual Meeting last year. Ten patients who had taken Elmiron for interstitial cystitis for 27 to 240 months developed macular disease. The most commonly reported symptoms were difficulty adapting to dim lighting and trouble reading.
Eye examinations showed pigmentary changes in the retina and abnormalities in the retinal pigment epithelium. The researchers noted that 156 patients who took other drugs for interstitial cystitis showed no evidence of pigmentary maculopathy.
Previous studies published in the Journal of Ophthalmology have also identified a strong correlation between pentosan polysulfate sodium (PPS) exposure and macular disease. Researchers have concluded that “this unique maculopathy is strongly associated with chronic PPS exposure, not IC itself or its other therapies.”
Long-term exposure increases the risk for maculopathy
According to Emory researchers, Adam M. Hanif, MD, and Nieraj Jain, MD, the length of Elmiron exposure plays a significant role in the risk of eye disease. Patients who take the bladder drug for five years or more may be at higher risk for developing maculopathy.
Pigmentary maculopathy is a degeneration of the macula, the central portion of the retina. With time, retinal pigment cells can die, resulting in Retinal Pigment Epithelial atrophy. There have also been cases of complete vision loss associated with PPS maculopathy.
Patients who suffer from pentosan polysulfate sodium-associated maculopathy are urged to find an alternative medication to treat their bladder condition and have routine retinal exams. Symptoms of vision disturbance and loss can persist and possibly worsen, even after the drug is stopped.
Elmiron complaints allege failure to warn
Elmiron makers have updated the product label five times but have yet to include any warnings about pigmentary maculopathy, or possible vision loss. Given the latency period for the manifestation of visual injury– thousands of patients taking PPS could potentially be at risk.
Patients who suffered Elmiron-induced vision problems claim that Janssen:
- Withheld material adverse events from the public and the medical community
- Failed to disclose the serious link between Elmiron use and significant visual injury, including pigmentary maculopathy
- Designed a defective drug
- Made no substantive changes to product label regarding Elmiron side effects despite numerous studies linking PPS and retina damage.
Protect your rights with Showard Law Firm
If you experienced significant visual side effects from Elmiron, such as pigmentary maculopathy or retinopathy, you deserve to be compensated for your medical bills, pain, and suffering. Showard Law Firm provides client-focused advocacy that gets exceptional results.
Discuss your eligibility for filing an Elmiron lawsuit with us today. Please call to arrange a private legal consultation, free of charge.
Additional Resources:
- Science Daily, More evidence linking common bladder medication to a vision-threatening eye condition https://www.sciencedaily.com/releases/2019/10/191012141218.htm
- com, Elmiron Side Effects https://www.drugs.com/sfx/elmiron-side-effects.html
- American Academy of Ophthalmology, Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium https://www.aaojournal.org/article/S0161-6420(17)33695-3/abstract
- Janssen Labels, Elmiron http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ELMIRON-pi.pdf?
- Review of Ophthalmology, Clinical Pearls for a New Condition https://www.reviewofophthalmology.com/article/clinical-pearls-for-a-new-condition