Up to 12 million Americans suffer from a severe bladder condition known as interstitial cystitis, or IC. Many have received relief for years by taking a prescription medication called Elmiron, or pentosan polysulfate sodium (PPS). New studies show that long-term use of this drug is linked to possible vision loss, retinal damage, and blindness.
Millions of Americans who took Elmiron could be at risk of developing a condition called maculopathy, which leads to permanent vision damage. Victims of eye damage related to Elmiron may be eligible for compensation through a drug injury lawsuit.
If you or someone you love has been taking Elmiron, there could be a risk for eye contracting disease. At Reeves & Mestayer, PLLC, we are fully prepared to advocate for your interests. Our experienced and knowledgeable personal injury attorneys will review your situation and outline your options for full recovery.
What is Interstitial Cystitis?
Little is known about interstitial cystitis (IC), but the disease continues to impact the lives of millions of Americans. What we do know is that it affects people across genders, races, ethnicities, and ages.
People with IC describe chronic symptoms in the urinary tract that can last for six weeks or longer. Some patients even deal with symptoms lasting up to two years. People with ongoing IC have hard bladders and a lower capacity for urine storage.
Contributing factors to IC include a history of irritable bowel syndrome, bladder infections, and physical or emotional stressors. People with this diagnosis may be more sensitive to certain foods and beverages.
According to the National Institute of Diabetes and Digestive and Kidney Diseases, IC is often treated by limiting the intake of certain foods and beverages and encouraging increased intake of fruits and vegetables. Alternative treatments for IC include physical therapy, bladder distention, surgery, and oral medications.
Treatment With Elmiron
Elmiron is the only FDA-approved oral medication for the treatment of IC. Researchers aren’t even sure how Elmiron helps patients with IC-related symptoms, but the benefits of treating this condition with the drug are well-documented.
In a double-blind clinical trial, Elmiron was successful in reducing IC symptoms within three months in 38% of patients. In another study, 61% of patients saw a reduction in symptoms using the drug.
Researchers suspect that Elmiron helps repair a thin, or damaged, bladder surface, which is a layer that protects the wall of the bladder from bacteria and irritating substances. Elmiron was approved by the FDA in 1996, and patients taking it for IC typically receive about three 100 mg doses daily. Within a month, many reported an improvement of their symptoms.
Many patients continue to take Elmiron for years for even decades, and there were no major side effects associated with the drug until recently. Physicians have readily prescribed Elmiron for IC, but new research indicates that, when taken long-term, the drug can have serious consequences for patients.
Elmiron and Maculopathy
In 2018, the American Academy of Opthalmology published research related to a link between Elmiron and an eye disorder called maculopathy. Specifically, Emory Eye Center recorded six cases between 2015 and 2017 of patients who were taking Elmiron and who were evaluated for this serious eye condition. By 2019, that figure had risen to ten patients. Another study in 2019 revealed that the rate of toxicity increased with the amount of the drug consumed over the years.
Maculopathy is a term referring to any pathology that affects the macula, or the central portion of the retina. Some of the different types of maculopathy include:
- Age-Related Macular Degeneration – loss of vision occurring over time that originates in the central field of vision.
- Malattia Leventinese – also known as Doyne Honeycomb Retinal Dystrophy (DHRD), and is characterized by small, pale spots originating in the macula and growing in a honeycomb pattern.
- Cellophane Maculopathy – also known as “macular pucker,” which results in a type of visual distortion due to the formation of a thin layer of scar tissue over the macula’s nerve cells.
While it isn’t known how or why Elmiron causes maculopathy, the link between the two has been established. Some of the symptoms that patients should watch out for include:
- Problems adapting to darkness
- Dimming of vision
- Paracentral scotomas (areas of partial vision loss)
- Metamorphosia (distorted vision)
In a 2020 study conducted in Europe, researchers issued new guidance on the link between Elmiron and eye damage. Specifically, medical experts recommend that patients taking Elmiron have an ophthalmologic exam after six months of use and reassess the use of the medication. Even if there are no findings of eye damage, ophthalmologic exams should be repeated every five years.
Elmiron Litigation – Protecting Your Rights
When a drug like Elmiron appears to be defective and causes harm to patients, there is often a recall to avoid additional injuries. While Canada has required the drug maker Janssen to update its list of side effects, the U.S. has not followed suit.
Patients who have taken Elmiron long-term to treat IC have been exposed to the potential for eye injury and vision loss. If you or a loved one has taken Elmiron and been diagnosed with a form of maculopathy, you may be entitled to compensation.
Janssen Pharmaceuticals, the drug’s manufacturer, has yet to warn patients in the U.S. about the risks of permanent vision loss or damage. If you qualify for an Elmiron lawsuit, our products liability attorneys will work to recover the following damages for your:
- Expenses for your medical care
- Loss of wages and lost earning capacity
- Loss of enjoyment of life
- Pain and suffering
These are complex and time-sensitive matters, so do not hesitate to reach out to an Elmiron litigation law firm today.
Speak With an Experienced Drug Injury Attorney
You have the right to safe products, and the eye disease associated with Elimron is not something that drug makers disclosed. We understand how to effectively pursue these cases and are not afraid of big companies and their legal teams. When you work with us, you won’t pay us a dime unless we win compensation on your behalf. Contact us today at 1-855-558-2977 or reach out to us online for a free case evaluation.