Research shows that a drug approved to treat bladder pain syndrome has been linked to irreversible vision damage, according to a recent news release from the American Academy of Ophthalmology.
Elmiron is the only approved drug to treat pain associated with interstitial cystitis (IC) – a condition that affects millions of Americans each year. Originally thought to be a drug with low-side effects and few risks, as many as hundreds of thousands of people may have taken Elmiron and been exposed to the risk of potentially permanent vision damage.
Prior to June 2020, Elmiron’s listed side effects and warnings did not warn about the risks of retinal pigmentary maculopathy, a progressive disease that can lead to vision loss in both eyes. Yet studies dating back to 2018 began to document the risk of irreversible vision loss for long-term users. If caught in its early stages, the damage may be stopped, but chronic exposure to the drug as well as higher dosages increase ocular toxicity. Despite adding a warning to the drug in June 2020, the FDA has not issued a statement or mentioned plans to request a drug recall.
As of September 2020, lawyers for plaintiffs nationwide have filed 50 cases in federal and state courts, alleging that the manufacturer of Elmiron failed to adequately warn doctors and patients about the drug’s potential vision-related side effects. Attorneys expect the litigation to grow based on the large number of Elmiron users and the unique nature of the injuries. Allen & Allen is investigating cases for people who took Elmiron for at least six months and suffered vision problems. These vision problems must have started while taking Elmiron or within one year of stopping treatment. The injuries alleged in the lawsuits include:
- Visión borrosa
- Degenerative maculopathy
- Halo vision
- Macular retinopathy
- Macular/pattern dystrophy
- Pigmentary maculopathy
- Reduced night vision
- Retinal pigment epithelium atrophy
- Unilateral or bilateral blindness
- Vision impairment
- Vision loss
If you have suffered vision problems after using Elmiron for an extended period of time, you may be eligible to recover damages. Contact Allen, Allen, Allen y Allen for a free case evaluation.
 The FDA documents vision-related side effects among Elmiron patients as far back as 1997. “Between 1997 and 2019, 10 cases identified as ‘eye disorders’ among Elmiron patients were filed with the FDA Adverse Event Reporting System (FAERS). Eighty of these were classified as serious. At least 22 of these reports mentioned some form of maculopathy.” Elmiron Lawsuits – Pigmentary Maculopathy, Levin Papantonio (Dec. 6, 2020), https://www.levinlaw.com/elmiron-lawsuit (last modified Dec. 6, 2020 at 10:36am).
 In a study conducted by Kaiser Permanente, 22 out of 91 patients who used Elmiron for the past 15 years had signs of toxicity. “The toxicity was greater in patients who took more of the drug – 11 percent in patients taking 500 to 1,000 grams and 4 percent in patients taking 1,500 grams or more.” Michelle Llamas, Elmiron Lawsuits, Drugwatch (Nov. 12, 2020), https://www.drugwatch.com/elmiron/lawsuits/.