Millions of Americans Have Macular Degeneration — Has Elmiron Made It Worse?

pill bottle and white pills on counter

When someone starts to lose their vision, it puts them and their families under incredible strain. Simple responsibilities become impossible tasks, as formerly independent people find themselves unable to read, drive, or recognize the faces of those whom they love.

Unfortunately, this story plays out in millions of American homes each year.

For many, blindness comes in the form of age-related macular degeneration. For others, sadly, vision-loss comes from taking a dangerous drug. It’s an awful side-effect they were never warned about.

Elmiron®, the brand name for pentosan polysulfate sodium, is a common bladder medication. Though it’s been on the market for years, it has been linked to eye disease in a series of recent studies.

In June of 2020, the U.S. Food and Drug Administration (FDA) added a warning to the label alerting consumers for the first time about the potentially irreversible vision damage.

As more research comes out that suggests Elmiron causes vision problems, many are now wondering if the supposedly safe drug they took robbed them of their vision.

Age-Related Macular Degeneration is Prevalent in America

It’s estimated that 11 million adults in the United States develop age-related macular degeneration (AMD), an eye disease that is the leading cause of blindness. Worldwide, some 170 million people are affected by AMD.

AMD affects the macula, the part of the retina responsible for clear central vision and the ability to see fine details. According to the U.S. National Eye Institute:

“AMD doesn’t cause complete blindness, but losing your central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house.”

Some people who develop AMD may start to experience vision-loss quickly, while others will have a much slower progression.

There is no cure for the most common form of AMD, known as dry AMD, though there are treatments to help slow the progression of the disease.

Wet and Dry AMD

There are 2 different forms of AMD:

  • Dry AMD: The most common form of AMD, accounting for 70-90% of cases, occurs when the macula thins as part of the aging process. Dry AMD tends to progress slower than Wet AMD, and generally affects both eyes.
    Common symptoms of dry AMD include the presence of drusen, small yellow or white spots on the retina. Drusen can be detected during a routine eye exam.
  • Wet AMD: The less common form of AMD, which occurs when abnormal blood vessels grow behind the macula. If these vessels leak fluid or blood, it can cause rapid vision loss. Common symptoms of wet AMD include general haziness of vision and seeing straight lines as being wavy or bent.

Given how many Americans each year are diagnosed with some form of macular degeneration, it’s important for people to be proactive about their eye health.

There are several promising new treatments for AMD. The earlier people discover there is a problem, the better the chance of receiving appropriate care and keeping their sight for as long as possible.

‘Safe’ Drug Elmiron May Increase Risk of Macular Degeneration

Elmiron has been on the market since 1996 and is the only FDA approved drug to treat interstitial cystitis (IC), a chronic condition causing pressure and pain in the bladder.

Depending on the severity of the condition, people may be prescribed Elmiron for years.

In several recent studies, results indicate that people who take Elmiron for long periods of time are at an increased risk of vision loss. Although most cases have been discovered in people who took the drug for 3 years or more, some who took the medication for less time have suffered the same problems.

The emerging eye disease has been called “pentosan-associated maculopathy,” after the generic name for Elmiron, pentosan polysulfate sodium. Maculopathy refers to a disease that affects the macula, the same part of the retina that is damaged due to AMD.

Current theories suggest that Elmiron is toxic to the retina, and causes problematic changes to a special layer of cells known as the retinal pigment epithelium (RPE).

The RPE plays an important role in maintaining eye health and good vision. Because Elmiron is thought to harm this pigmented layer, some researchers have called the damage it causes “pigmentary maculopathy.”

The longer someone has taken Elmiron, and the total amount of the drug that a person has taken over time, appear to be risk factors.

Unfortunately, the condition has been found to worsen, even after people stop taking Elmiron.

What Consumers Need to Know About Elmiron

Research is ongoing, but the FDA has approved changes to the warning label on Elmiron that inform consumers about the link between the drug and eye disease.

The most common visual symptoms reported by patients in studies on Elmiron are:

  • Blurred vision
  • Difficulty adjusting to low or reduced light environments
  • Trouble reading

People who are currently taking Elmiron are advised to talk to their doctor about the risks of eye damage associated with the continued use of the medication.

Pigmentary changes in the eye can occur for a number of reasons. Patients should share their family medical history with their doctor so that a doctor can better distinguish hereditary issues from Elmiron-associated macular damage.

Regular screenings and eye examinations are encouraged by the FDA. If exam results show pigmentary abnormalities, or a person experiences changes in their vision, patients should reassess the benefits and risks of using Elmiron.

Vision problems caused by Elmiron are irreversible, and it may no longer be a good idea to keep taking more. Routine follow-up examinations should continue, even after people stop taking the medication.

Elmiron has not been recalled and is still the only approved treatment for IC.

For people who are thinking about taking Elmiron, they should also have an open and honest discussion with their doctor about their family’s history of eye disease, as well as any pre-existing eye conditions they have.

The doctor will conduct tests in order to measure a person’s eye health before starting treatment, and routinely thereafter. With pre-treatment exam results, doctors can better detect pigmentary changes caused by Elmiron.

Elmiron Lawsuits Provide a Way Forward

Because so much of the vision-loss in America is due to age-related macular degeneration, the damage caused by Elmiron remained undetected for 25 years.

In that time, many people taking Elmiron to treat interstitial cystitis unknowingly put themselves at risk of going blind. Many lost the freedom to drive, the joy of reading, and the ability to help around the house.

Until 2020, people who took Elmiron were never warned it could potentially lead to irreversible vision loss. They were deprived of making an informed decision about their health and future.

People who have been hurt are now coming forward to file Elmiron lawsuits. Companies need to make sure that the drugs they market are safe to take, especially over long periods of time. When they don’t alert consumers about serious health issues, it’s a crime.

If you have taken Elmiron and suffered vision problems, get in touch with us today.

At Sokolove Law, we have helped people injured by dangerous drugs secure the compensation they deserve. In bringing your case forward, we encourage drug companies to be more open and honest about the risks associated with their drugs.

Call us today for a free legal case review, and find out if you may be eligible for compensation.

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Author:Sokolove Law Team
Sokolove Law Team

Contributing Authors

The Sokolove Law Content Team is made up of writers, editors, and journalists. We work with case managers and attorneys to keep site information up to date and accurate. Our site has a wealth of resources available for victims of wrongdoing and their families.

Last modified: May 13, 2021

View 8 Sources
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