A drug used to treat interstitial cystitis, of which there is no cure, has been linked to causing an irreversible eye disorder with some long-term users. The drug is Elmiron and many patients are now taking legal action because of this, and rightfully so.

Interstitial cystitis (IC for short) is a condition that causes recurring pain in the pelvic region, but typically manifests in the bladder. Known by the names chronic pelvic pain, painful bladder syndrome, or bladder pain syndrome– it’s pretty clear based on such names, those who are diagnosed want quick relief. 

Elmiron (pentosan polysulfate sodium) is the medication that supposedly comes with that relief. The condition does not discriminate against gender, as some one million men and women suffer from IC.

Manufactured by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) Elmiron has been around since the 1990s. It is one of the only medications approved by the U.S. Food and Drug Administration to treat interstitial cystitis. Due to this fact alone, hundreds of thousands of people have been exposed to this medication to treat IC.

As with any medication, Elmiron does come with side effects. According to WebMD, those include diarrhea, hair loss, nausea, headache, stomach upset, and abdominal pain. 

The current side effects of Elmiron listed do not include any warnings about vision problems. But ask some thousands of users who have begun filing lawsuits, and they will tell you a different story. Notably a condition called toxic maculopathy, which can potentially cause irreversible vision damage, has been linked to Elmiron.

Toxic maculopathy damages the macula, the back part of the retina. The retina is responsible for sensing changes in light and sends a signal to the brain, which allows people to see. If the retina is damaged, there is a high chance of irreversible vision changes. 

Elmiron has been linked to a specific type of maculopathy called pigmentary maculopathy. Studies have shown this to be especially prevalent in Elmiron users. The damage may stop if caught in the early stages of pigmentary maculopathy. 

In some Elmiron studies, difficulty reading or difficulty adapting to dim lights were reported by users. Other symptoms of vision damage include paracentral scotoma (vision loss in the field of vision), difficulty seeing objects that are close, and vision dimming. 

Other vision side effects that may be the result of Elmiron use include, but are not limited to: vision loss, vision impairment, macular retinopathy, halo vision, metamorphopsia, reduced night vision, retinopathy, scotoma, unilateral or bilateral blindness, blurred vision, halo vision, macular retinopathy, or macular/pattern dystrophy.

Many studies have shown a link between Elmiron and pigmentary maculopathy.

In 2018, the Atlanta-based Emory Eye Center published a study that involved six individuals who were taking pentosan polysulfate sodium for IC. This study indicated long-term exposure to the drug caused pigmentary maculopathy. 

Later that year, at an American Academy of Ophthalmology conference in San Francisco, researchers from Kaiser Permanente presented a study that linked vision damage to pentosan polysulfate sodium. The ophthalmologists included Robin A. Vora, M.D , Amar P. Patel, M.D., and Ronald Melles M.D.

The researchers studied 140 patients who had taken pentosan polysulfate sodium for 15 years. Though only 91 agreed to be examined, 22 of them had signs of toxicity based on their findings. It also showed the greater damage correlated with a greater amount of medication they were prescribed.

“It’s unfortunate,” Dr. Vora said. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”

In November 2019, Dr. Rachel M. Huckfeldt and Dr. Demitrios G. Vavvas published a study in Ophthalmic Surgery about a patient whose maculopathy continued to worsen six years after stopping Elmiron. 

In 2019, the FDA updated its Adverse Event Reporting System (FAERS) to include eye disorders as a serious risk/new safety information for Elmiron. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2019-potential-signals-serious-risksnew-safety-information-identified-fda-adverse

It’s one thing for studies to come out about the link between vision damage and Elmiron use, but what about the companies that continue to manufacture it? Many people have started seeking legal action to hold the pharmaceutical companies responsible for failing to warn patients about the potential damages. 

Here is a link to an advocacy group who profiled the first Elmiron lawsuit filed in the United States.