Elmiron Prescription Drug Linked to Eye Damage

Recent research has linked the popular prescription medication Elmiron to serious and irreversible cases of eye damage. Retinal pigmentary maculopathy is one of the effects that has appeared in patients as a direct result of taking Elmiron.

What Is Elmiron?

Elmiron (pentosan polysulfate sodium), which is manufactured by Janssen Pharmaceuticals, is a drug approved by the FDA to treat bladder pain and discomfort associated with interstitial cystitis.

It acts as a weak blood thinner and works by forming a protective coating on the inner lining of the bladder that reduces irritation by substances present in the urine. Because it’s a first-line drug that has been in use since the 1990s,, it’s believed that at least several hundred thousand people have likely been exposed to the drug and have potentially been affected.

Elmiron Treatments

Elmiron has been widely prescribed to treat adults suffering from the chronic pain and discomfort of interstitial cystitis (IC), bladder pain, and pelvic pain for decades. IC causes pain in the pelvic area and a frequent, urgent need to urinate.

More than one million people in the United States, mostly women, are estimated to have the condition. Currently, Elmiron is the only Food & Drug Administration (FDA) approved medication to treat IC.

This makes knowledge of the observed side effects even more devastating, as Elmiron has been the sole recourse against debilitating pain for many patients with the condition, who are now left without a safe treatment option.

Side Effects

The most common side effects of Elmiron are headache, dizziness, abdominal pain, diarrhea, nausea, hair loss and rectal bleeding.

However, the recently observed eye damage is the most serious side effect. Its effects may cause patients to have difficulty reading or adapting to dim lighting, blurred vision, dark spots in the center of their vision, straight lines appearing wavy, and colors appearing muted and less vivid. Tragically, it can even cause irreversible blindness in one or both eyes.

Studies That Have Been Conducted

A report was first filed in 2018 that suggested Elmiron was potentially linked to retinal damage. This was then followed up by subsequent research by leading ophthalmologists who proved that as many as one-fourth of the patients in their studies had significant vision damage due to taking the drug. All the participants had been regularly taking Elmiron for at least 15 years.

FDA Response

The FDA recently added eye disorders related to the drug to the list of “Potential Signals of Serious Risks” generated by its Adverse Event Reporting System and is currently evaluating the need for regulatory action.

What This Means for Affected Patients

It’s important to point out that Elmiron has no warnings regarding eye problems in its labeling, and there are now several dozen adverse cases of eye disorders and vision problems directly related to Elmiron.

As a result of taking Elmiron, some patients are now, through no fault of their own and with no warning, suffering from a variety of serious vision problems, ranging from vision impairment to blindness in one or both eyes, which is considered to be irreversible.

Currently, Elmiron lawsuit lawyers are fighting cases for patients who have suffered from these impactful, undisclosed side effects. Although the damage is already permanent for some suffering patients, lawsuits offer a means for people to hold pharmaceutical companies accountable for the harm they have caused in such circumstances.