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A medication that is prescribed to treat various bladder issues has been linked to a rare vision problem known as pigmentary maculopathy, and other conditions which can cause the victim to lose his or her sight.
Recent research reports show that condition occurs in patients who have been using Elmiron long-term and is causing vision loss.
Unfortunately, permanent injury from pharmaceuticals is not new to legal practices, but we at Napoli Shkolnik are working diligently on any existing cases that we have and remain available during this pandemic for those who need legal assistance.
While the COVID-19 crisis has caused some law offices to close, we will continue to serve our clients in any way possible.
As many as twenty-five percent of those who are prescribed Elmiron and take it long-term for bladder issues are eventually diagnosed with retinol damage from the drug.
While this Elmiron medication has been used for decades, it appears to be damaging to the retina, causing issues that can adversely affect a patient’s eyesight leading to vision loss.
An initial report was filed in 2018 which suggested that the drug Elmiron, or pentosan polysulfate sodium, was linked to retinal damage.
This report led to a review from three prominent ophthalmologists.
These doctors studied patients in Northern California at Kaiser Permanente.
The study proved that as many as one-fourth of the patients in the study had significant vision damage after being exposed to the drug manufactured by Janssen Pharmaceuticals.
These physicians also noted that the damage could be wrongfully diagnosed as other retinal issues, such as pattern dystrophy or age-related macular degeneration.
Attorneys are also seeing cases of pigmentary macula and maculopathy, which can cause the patient to go blind.
Elmiron is marketed by two companies, Teva Branded Pharmaceuticals in Pennsylvania, and Janssen Pharmaceuticals in New Jersey.
Janssen is part of the Johnson & Johnson group of companies.
Elmiron has been marketed by these companies since the 1990s for people with a painful bladder condition known as interstitial cystitis, which causes the sufferer to experience chronic pain in the pelvic area and bladder.
Over a million people in the United States suffer from interstitial cystitis, and most of them are women.
There is currently no pill manufactured and approved by the FDA to treat this condition other than Elmiron.
Since it has been the only treatment for interstitial cystitis for decades, there are likely hundreds of thousands of people who have been exposed to it and its risks.
It is too early to gauge just how many may have gone completely blind due to this drug and its effects.
In 2018, a doctor from Emory Eye Center in Atlanta, Georgia discovered that six patients who had been using the drug Elmiron for around 15 years were showing signs of damage to the macula of their eyes.
Nieraj Jain, M.D. grew concerned because there was nothing in the medical history of these patients nor in their diagnostic tests to explain the damage they were experiencing to the part of the retina responsible for giving us clear vision.
At that time, Jain and his colleagues gave a warning that Elmiron could be causing the damage and that further studies were needed.
Three other doctors, Ronald Melles, M.D., Amar P. Patel, M.D., and Robin A. Vora, M.D, all ophthalmologists at Kaiser Permanente, decided to listen to that warning.
They examined their patients and saw that there was, indeed, an issue with one woman who had been diagnosed with retinal dystrophy and had been on Elmiron long-term.
This discovery led these three doctors to examine the rest of the 4.3 million patients in Kaiser’s database.
Of those millions of patients, the doctors found 140 who had taken Elmiron for about 15 years.
On average, each patient had taken approximately five thousand of the pills during that time.
Ninety-one of those patients agreed to come in and be examined by the doctors for signs of vision problems stemming from taking Elmiron.
The doctors took images of the patients’ eyes, focusing heavily on the back of the eyes where this damage occurs.
The pictures were arranged in three separate categories. The first category showed no damage to the retina.
The second category showed possible damage. The third showed definite issues in the retina.
Of those 91 patients, 22 showed clear signs of retinal damage, and the extent of the damage was in direct correlation with the total grams that each patient had consumed.
Those who had taken more of the drug over time showed more damage.
Dr. Vora shared frustration at the situation and explained that for many patients with the extremely painful condition of interstitial cystitis, this medication is the only one available.
Since there is no cure and no effective treatment plan, patients are desperate for help and will eagerly accept the drug without understanding the risks.
If patients are not warned of the serious side effects of these drugs, they do not even have the opportunity to deny their use.
For those who are warned about the damage, there are ways to make sure that the damage would be minimal.
Although it is unclear just how much of the drug is too much, patients who are using Elmiron should be checked regularly by their doctors for damage to the retina.
If any damage is found, the medication should be stopped.
The good news is that if the damage is found early enough, the damage can be mitigated by ending the treatment.
Unfortunately, that does not help the thousands of patients who were given this drug without warning of the damage that it could cause.
In a lawsuit filed on March 26, 2020, in Connecticut, several plaintiffs are suing Janssen Pharmaceuticals for failing to provide ample warning about the retinal issues caused by their product.
These plaintiffs maintain that they were never warned of eye damage linked to this drug, nor were they told that they should have regular eye exams while using Elmiron.
If you or someone you know has suffered retinal damage or vision problems while taking Elmiron, don’t hesitate to call Napoli Shkolnik PLLC.
Even during the COVID-19 pandemic, we are ready to help you in any way possible to seek compensation for your injuries.