During the 2019 Annual Meeting of the American Academy of Ophthalmology (AAO) in San Francisco, a new study was presented which revealed new evidence of links between popular bladder medication Elmiron (pentosan polysulfate sodium), maculopathy, and retinal damage.
Investigators from Northern California's Kaiser Permanente found that the use of Elmiron caused retinal damage in approximately 25% of the patients they analyzed. Elmiron is the only FDA-proved pill used for treating interstitial cystitis - a condition characterized by pain and pressure in the bladder, along with pelvic pain in some sufferers.
Furthermore, the investigators determined that it can be difficult to realize that this damage has been caused by Elmiron due to the fact that the damage often resembles other retinal conditions, like pattern dystrophy and age-related macular degeneration.
This study was conducted in response to a 2018 study that showed 6 patients in Atlanta, GA had experienced unusual macula changes while taking Elmiron. Kaiser Permanente clinicians conducted the study to determine if this correlation could be found in their patients as well. An initial assessment found that a patient on long-term treatment had been misdiagnosed with retinal dystrophy, prompting clinicians to examine their entire database of 4.3 million patients.
Kaiser Permanente investigators found a group of 140 patients who had taken an average of 5,000 Elmiron pills over 15 years. 91 of those 140 agreed to participate in an examination for the study.
Investigators photographed the back of the 91 patients' eyes and classified them into three groups based on abnormalities: normal, possible abnormality, and definite abnormality. 22 of these 91 patients showed "clear signs of drug toxicity."
The study also found that toxicity levels increased in correlation with the amount of Elmiron patients took. Those who took 500 to 1000 grams had a toxicity rate of 11%, while users who took 1500 grams or more saw a drastic jump to a toxicity rate of 42%. Investigators also noted that late-stage damage often appears to be late-stage dry atrophic macular degeneration and can lead to permanent loss of vision.
Kaiser Permanente ophthalmologist Robin Vora, MD has advised Elmiron users who show no signs of toxicity to undergo annual toxicity screenings. Those who have shown signs of retinal damage have been advised to speak with a urologist or OB/GYN about possibly discontinuing their use of Elmiron.
Our defective drug lawyers believe that there could be many more people affected by Elmiron-related eye issues than have been discovered in this study. Many sufferers may not realize that their issues have been caused by Elmiron due to the fact that symptoms often mimic other retinal issues.
Pharmaceutical companies are responsible for ensuring the safety of the drugs they put on the market. When a drug causes severe damage to users, those affected by the defect often have grounds for a lawsuit against the pharmaceutical company.
If you or someone you love has suffered from eye problems and you believe that Elmiron may be to blame, our defective drug lawyers would be happy to help you explore your legal options in a free consultation.