Elmiron May Cause Serious Eye Damage

We all take medicine to make us feel better; to fix a problem within our bodies; to balance a systemic imbalance. We trust medicine. But what’s truly disheartening is the reality that some prescriptions might alleviate one illness while creating a much larger problem. Unfortunately, such seems to be the case unraveling with Elmiron, a pill prescribed to help people with a painful bladder disorder but is now thought to cause serious eye damage.

WHAT WE KNOW

Elmiron is manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals and has been on the market since 1996. It’s used to treat a painful bladder condition called interstitial cystitis, or IC. Aimed to create a barrier on the bladder wall to protect it from irritants in urine, Elmiron was approved by the FDA under the Orphan Drug Act, which gives special status and incentives to manufacturers of medications that treat rare diseases. Elmiron is the only oral drug approved to treat bladder pain associated with IC, a condition that affects millions of Americans each year.

SIDE EFFECTS

The list of side effects that Janssen Pharmaceuticals currently claims for Elmiron is already lengthy and scary enough, including abnormal liver functions, hair loss, bloody stool, nausea, dizziness and more. But there is no mention of a potentially life-altering retina disorder called maculopathy that can lead to permanent blindness.

Why wasn’t this potential side effect disclosed to patients and doctors? Was Janssen Pharmaceuticals hiding a potential side effect that could cause people to lose the ability to see for the rest of their lives?

THE TIMELINE

Starting in 2018, a growing number of studies and research began to document irreversible vision problems with long-term use of Elmiron. It all began with Dr. William A. Pearce and colleagues at the Emory Eye Center who astutely realized that six of their female patients all presented with the same strange form of maculopathy—and all six had been taking Elmiron for IC. The doctors later published an expanded 10-patient study in the Journal of Urology recommending patients with signs of maculopathy stop taking the drug and patients with no symptoms undergo an ophthalmic examination with retinal imaging. 

Many more studies have since followed, including one earlier this year by Drs. Robin Vora, Amar Patel and Ronald Melles study of 117 patient. They wrote, "We believe that our findings add strong support to the growing body of evidence that links long-term PPS [pentosane polysulfate sodium, also known as Elmiron] use to the potential development of a toxic maculopathy.”

WHAT IS MACULOPATHY?

Maculopathy is any pathological condition of the macula, an area at the center of the retina that is associated with highly sensitive, accurate vision. The retina senses light and sends a signal to the brain, allowing us to see. Damage to the retina means damage to our sight, or in extreme circumstances, complete blindness. Maculopathy is the most common cause of blindness in the U.S.

Another strange finding—Elmiron specifically causes a type of maculopathy called pigmentary maculopathy. Studies have found this type to be unique to Elmiron users.

WHAT DO I DO IF I’VE TAKEN ELMIRON?

Lawsuits are being filed across the country, but so far, the FDA has not made a formal statement. If you or your loved one has taken Elmiron, please ask your doctor if you should stop taking it. Please also see an Ophthalmologist for retinal imaging.

Get Help From Our Expert Dangerous Drug Claim Attorneys

If you develop maculopathy while or after taking Elmiron, please call our bad drug expert attorneys at The Maher Law Firm. We’re here to help stop Big Pharma from making money off prescriptions and over-the-counter drugs that don’t do what they claim and/or have serious side effects.

UPDATE: JANSSEN ADDS RETINAL CHANGE WARNING TO ELMIRON LABEL

As of June 16, 2020, Janssen Pharmaceuticals has added maculopathy to the warning section of their label. The label now includes this verbiage:

"WARNINGS

Retinal Pigmentary Changes

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.”