Elmiron: The Popular Bladder Drug May Cause Blindness

According to recent studies the widely used bladder drug Elmiron may cause eye damage. Recent studies strongly suggest that the drug — known as pentosan polysulfate sodium and used by hundreds of thousands of people for decades — may be highly damaging to the retina, the light-sensing tissue at the back of the eye. The American Academy of Opthamology reports that doctors studying the drug recommend eye imaging for patients currently on Elmiron to determine whether maculopathy is present and discontinuation of the drug if maculopathy is found.

In a 2018 study three Kaiser Permanente ophthalmologists examined a database of 4.3 million patients in Northern California and identified 140 patients who’d taken an average of 5,000 pills each over 15 years. Of those 140 patients, 91 agreed to an exam, and the researchers took detailed images of the back of their eyes. Twenty-two of the 91 patients showed clear signs of Elmiron toxicity. The rate of toxicity rose with the amount of Elmiron taken.

Of the patients examined roughly 25 percent of the patients who’d taken large amounts of Elmiron had clear signs of eye damage, and that damage caused by the drug could be mistaken for other retinal conditions, such as age-related macular degeneration or pattern dystrophy.

Other potential diagnoses and side effects identified may include:

• Pigmentary Maculopathy

• Retinal Maculopathy

• Macular Degeneration

• Pattern Dystrophy

• Vision Loss / Vision Impairment

• Visual disturbances

• Blurred Vision

• Blindness (unilateral or bilateral)

A study in JAMA Ophthalmology found that patients with exposure to PPS experienced metamorphopsia, in which straight lines may appear wavy, blurred vision, and prolonged dark adaptation. A similar study published in the Journal of Urology identified the most common symptoms of PPS-related ocular problems as difficulty reading and adapting to dim lighting. Authors of studies discussing these PPS-related eye problems have described PPS-related ocular toxicity as “vision-threatening.”

Elmiron has no warnings regarding eye problems in its labeling and there are now several dozen adverse events related to eye disorders and vision problems similar to those discussed in the medical literature that have been reported in the FDA’s FAERS database.

Elmiron is currently the only drug approved by the Food and Drug Administration to treat interstitial cystitis, which causes chronic pain in the bladder and pelvis area. It’s estimated that more than 1 million people in the United States, mostly women, have the condition and that hundreds of thousands of people have been treated with Elmiron. Notably, many women who were treated with vaginal mesh and the Essure Sterilization device may be at a particularly high risk for interstitial cystitis. 

While the medical community has only recently learned of this connection, Elmiron’s manufacturer Janssen has known of the link between Elmiron and eye damage for over 20 years.  In early clinical trials of patients who took Elmiron for up to four years, both vision and eye related adverse events were reported.

Although Janssen knew of the link between Elmiron and eye damage for more than 20 years, the company never added warnings to the label or conducted further research on the link between Elmiron and eye damage.  Instead, they ignored the risks and went on to earn billions of dollars selling Elmiron.  Now they will face thousands of lawsuits from patients that suffered severe eye damage. 

Lawsuits have already been filed that claim long-term exposure to Elmiron causes maculopathy, an eye disorder affecting the macula (central part of the retina) and a major cause of blindness. If you or a loved one have been injured by Elmiron, contact Holly Ennis at Ennis & Ennis, P.A. for a free consulation or visit us online at www.Ennislaw.com or directly at Holly@ennislaw.com.