The Elmiron (Pentosan) Vision Loss Risk and Why You Should Speak with an Attorney
Elmiron is a blood-thinning drug (anti-coagulant) prescribed to help treat pain caused by interstitial cystitis, commonly known as “painful bladder syndrome”. The active ingredient in Elmiron is pentosan polysulfate sodium (PPS). First approved for use in 1996 to be taken orally each day, Elmiron works by adding a coating of protection to the inner bladder walls to help mitigate irritation and discomfort caused by the disease.
Elmiron has recently been linked to a degenerative disease called retinal maculopathy, which can cause severe vision damage and even permanent vision loss. The FDA rejected this drug twice due to pre-approval fatal flaws, while the manufacturing company, Johnson & Johnson, has been aware of vision-related injuries linked to Elmiron since the 1990s but has taken no action. The company also never issued warnings on the label of the risk of vision loss from retinal maculopathy. If you or a loved one has taken Elmiron and have been diagnosed with retinal maculopathy, call the law offices of Edward M. Bernstein & Associates, Las Vegas’s most trusted personal injury attorneys.
What is the problem?
Recent research has linked Elmiron to a unique form of progressive eye disease that, in the past, has been typically diagnosed by ophthalmologists as retinal pigmentary maculopathy, pattern dystrophy, or age-related macular degeneration. However, between 2015 and 2018, six female patients of the Emory Eye Center in Atlanta, Georgia, were found to have developed a new eye disease classified as “retinal maculopathy”. This causes a change in eye color that perpetuates a significant vision and eye dysfunction over the course of four to five years, similar to the effects seen in patients with age-related macular degeneration.
After reviewing each patient’s history, doctors found that all the patients had one commonality: they had all been diagnosed with interstitial cystitis and were currently taking the drug Elmiron.
This news worried the medical community, and researchers at Kaiser contacted 140 patients in their database that had been using Elmiron consistently for at least five years to ask them to undergo an eye examination. Of the 140 patients, 91 agreed to have their eyes examined and 22 of them were found to have developed the exact Elmiron-associated retinal maculopathy and pigmentary damage that was presented in the original Emory Eye Center study. This 24% of patients not only had significant damage to their retina, but they also reported significant eye and vision problems as a result.
The IC Network, an advocacy group for patients with interstitial cystitis, conducted its own survey of members who had taken the prescription drug Elmiron. The results showed that of 1,604 patients surveyed, 53.7% had developed retinal disease. Several case studies have also shown that the retinal disease can continue to worsen even when patients stop taking the drug.
When the retinal maculopathy in the original six patients was discovered to be Elmiron-associated, researchers looked back at all the early clinical trials of Elmiron that the manufacturer had performed. The researchers found that in a clinical trial of 2,499 patients who took Elmiron for up to four years, both vision- and eye-related issues were, in fact, reported. The manufacturer of Elmiron knew that patients in the drug’s clinical trials were found to develop optic neuritis and retinal hemorrhage—but this information was not included anywhere on the drug’s warning label. Furthermore, no tests or research was done to explore if a mechanism of Elmiron could cause such serious eye disorders. The manufacturer of Elmiron has simply ignored this possibility.
What is Retinal Maculopathy?
Retinal maculopathy can cause potentially severe vision damage or loss, as well as other symptoms linked to the drug Elmiron. Maculopathy is a disease that affects the macula. The macula is the part of the retina responsible for producing accurate and highly sensitive vision. Symptoms like pigmentary maculopathy may be mild or severe, depending on the degree of retinal damage that has occurred.
Possible Retinal Maculopathy Symptoms: (4 + years of use)
- Prolonged light to dark adaptation
- Blurry vision while reading
- Metamorphopsia (lines look curvy)
- Central vision loss in advanced cases
- Initial symptoms may present as generalized dimming in vision
- Other visual symptoms (floaters, spots, impaired color vision)
- Retinal toxicity
- Halo vision
Why should you speak with a personal injury lawyer?
If you or a loved one have taken the interstitial cystitis drug Elmiron, you should see an ophthalmologist to check the health of your eyes and retinas. This way you can monitor and possibly stop any progression of eye disease. If you do develop symptoms of the disease, you may be entitled to a settlement. Edward M. Bernstein & Associates will use our expertise to help you win your case.
What should you look for in an attorney?
When looking for a personal injury attorney in Las Vegas, you need someone with expertise in dealing with these types of medical claims. You need someone who has a track record of winning. You need Edward M. Bernstein & Associates. Call us to learn more about how we can help you maximize any settlement that you win.
When you need an experienced personal injury attorney in Nevada to help you file a Elmiron lawsuit, call Ed! The experienced lawyers at Edward M. Bernstein & Associates are here to help you. We have the experience and expertise to win these cases. Call us now at 702-508-7943 to schedule your free consultation with our office.