Elmiron is a drug used to treat bladder pain caused by a chronic condition called interstitial cystitis. However, a growing body of evidence suggests that this drug causes an ocular disorder called maculopathy, which affects the macula, a central part of the retina. While maculopathy’s initial symptoms may include blind spots, blurred vision, and difficulty reading, it can lead to the total loss of vision.
If you or someone you know has taken the drug Elmiron and suffered from maculopathy, vision problems, or other ocular issues, you may be eligible to file an Elmiron lawsuit. At Mass Tort Alliance, our experienced Elmiron mass tort attorneys are ready to review your case and act on your behalf. Take our quiz today to learn more about your options for holding the manufacturer of Elmiron liable for the injuries and losses you’ve suffered.
Elmiron, also known as pentosan polysulfate sodium, is a drug manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and is used to treat patients suffering from interstitial cystitis. Elmiron was approved by the Food and Drug Administration in 1996 for the treatment of bladder pain or discomfort associated with interstitial cystitis.
In June 2020, Janssen added a new warning to the Elmiron label. The warning noted the potential for retinal pigmentary changes. Symptoms of this retinal issue include difficulty reading, inability to see clearly, and trouble adjusting to low light. At this time, there have been no recalls of the drug, however, more studies are being reviewed. While the FDA has not recommended a recall, they are expected to continue monitoring the situation.
Interstitial cystitis is a chronic pain syndrome of the bladder. More than one million men and over three million women in the United States are estimated to have this incurable condition. This condition results in a feeling of pain or discomfort in the bladder area, with no associated infection or cause. Patients exhibit symptoms ranging from mild to severe with no clear reason as to why.
This condition is more common in women, but many men have been diagnosed as well. Many suffer without a diagnosis for months and sometimes years. An official diagnosis often occurs by process of elimination. There is no official medical test for diagnosis, so medical providers often rule out other health conditions which may be causing patients’ symptoms and pain.
Treatment of interstitial cystitis usually begins with making lifestyle changes that may relieve the pain and discomfort of IC. If lifestyle changes are not enough, prescription drugs may be used to manage the disorder.
Elmiron is the only oral medication approved by the FDA. It is unknown how this drug works at treating the symptoms, but it is theorized to build and restore a protective coating of the tissue surrounding the bladder. Because interstitial cystitis is so uncomfortable, it often affects the patient’s sleep, exercise routine, and social life. It can be all-consuming for those dealing with the diagnosis.
Maculopathy, also called macular retinopathy, is a disease of the macula, the small part of the retina at the back of the eye. The retina is the layer of the eye that contains light-sensitive cells. The retina receives and sends information through electrical impulses that travel through the optic nerve to the brain. The macula itself allows you to see fine details clearly.
A steadily increasing amount of research has linked Elmiron to the development of maculopathy in interstitial cystitis patients.
In 2019, a study appearing in the American Academy of Ophthalmology demonstrated a compelling link between Elmiron use and vision damage. After an initial 2018 report linked Elmiron to retinal damage, more in-depth research was undertaken to further study the link between vision issues and the bladder medication.
Three ophthalmologists reviewed patient files at Kaiser Permanente in North Carolina and found that about 24 percent of patients with significant exposure to Elmiron suffered eye damage. The medication appears to cause toxicity to the retina’s macula. Of the ninety-one patients who were examined with detailed imaging of the back of their eyes, twenty-two of those patients had a clear indication of drug toxicity.
Many physicians have continued to research the effect of the medication on their patients over the years. In another ocular study looking at 80 IC patients who had taken Elmiron, 14 patients had characteristic maculopathy. No cases of maculopathy were detected among the IC patients who had not been exposed to Elmiron.
Another case suggests that the onset of Elmiron maculopathy can develop even after the drug was no longer used by the patient. A 44-year-old female who took and then ceased taking Elmiron developed maculopathy 38 months after drug cessation.
In a multi-institutional case series, a review of medical records found 35 patients who all had drug exposure, vision issues, and retinal imaging indicative of retinal toxicity. The review suggested that long-term use of the drug Elmiron may result in maculopathy.
Since Elmiron is the only FDA-approved drug to treat the incurable diagnosis of interstitial cystitis (IC), there are thousands of patients throughout the U.S. who have potentially been exposed to the harmful effects of this drug.
There are several studies that suggest the longer you have taken the drug, the greater your risk of vision problems or vision loss. One suggestion is that patients taking Elmiron should have a yearly eye exam to stay on top of any issues that may arise.
Dr. Ming Wang, who owns Wang Vision in Nashville, Tennessee, said that side effects often go unnoticed for long periods of time since most drug trials last between two to five years. Many patients were using Elmiron for over twelve years before being diagnosed with a retinal problem.
Dr. Alena Reznik, an ophthalmologist and glaucoma specialist, believes that vision loss is rare but also dependent on drug dosage and length of time. According to Dr. Reznik, “vision loss is rare and cumulative dose-dependent but may be severe and irreversible.”
Unfortunately, numerous Elmiron patients weren’t screened for maculopathy over time because they didn’t know it was a risk.
If you have suffered vision problems or damage to your retina as a result of taking Elmiron, you may be able to recover compensation for the damages, or losses, you have incurred as a result of your injuries. These losses may include:
Our attorneys will review the extent of your injuries and losses to help you determine how much your case may be worth.
It’s believed that there are more than 50 active Elmiron cases in state and federal courts across the U.S., and attorneys expect the number of cases to continue to grow.
For example, on March 26, 2020, plaintiff Kimberly Pelczar filed a lawsuit against Elmiron manufacturers, alleging that the drug makers failed to warn doctors and the public about the vision problems associated with the drug. Pelczar was diagnosed with vision loss and permanent retinal injury in 2019.
On June 8, 2020, plaintiff Valerie Hull also filed a lawsuit against Elmiron drug manufacturers. Hull took Elmiron from 2001 to 2008 and suffered severe vision loss.
Following are statistics related to the use of Elmiron in the U.S. and the link between the drug and ocular side effects:
According to the National Institutes of Health that between 3 million to 8 million women and between 1 million to 4 million men suffer from interstitial cystitis in the U.S. Given these numbers, it’s estimated that hundreds of thousands of patients may have been exposed to Elmiron.
In the 2019 Kaiser Permanente study of Elmiron’s potential to cause retina damage, 24 percent of the patients show signs of drug toxicity and damage to their eyes. Kaiser Permanente’s study included patients who had taken an average of 5,000 pills per person over the course of 15 years.
The Kaiser Permanente study also found that the rate of toxicity rose with the amount of the drug that was taken: 11 percent of those taking 500 to 1,000 grams suffered toxicity and eye damage, while 42 percent of those taking 1,500 or more suffered toxicity and eye damage.
A study of U.S. medical claims published in the British Journal of Ophthalmology found that Elmiron users who had taken the drug for seven years had increased odds of developing atypical maculopathy.
Now is the time to file your case. As more information is released and more studies are reviewed, the number of cases filed is likely to rise. Lawyers with Mass Tort Alliance are accepting cases from patients who took Elmiron and suffered injuries and damages as a result.
Finding a qualified attorney to take your case is essential to your financial recovery based on the damages you have suffered. At Mass Tort Alliance, our attorneys will investigate your case thoroughly to help show the link between your injuries and Elmiron and also work to identify the extent of your injuries. We’ll hire top-notch medical experts, when necessary, to testify on your behalf and strengthen your case. And we’ll also develop an aggressive legal strategy that meets your goals.
Our attorneys will be by your side through every step of the legal process. Don’t wait any longer – start taking steps to get your life back. If you believe you have a case related to the drug, Elmiron, take our quiz to learn more about your options. We’re here to help.