Elmiron Bladder Pain Drug Warning Added by J&J

Made by Janssen Pharmaceuticals, a division of Johnson & Johnson, Elmiron (pentosan polysulfate sodium), was approved by the U.S. Food and Drug Administration (FDA) to protect the bladder wall from irritants in urine, which causes interstitial cystitis or painful bladder syndrome.

Elmiron actually works like heparin and is a weak anticoagulant, acting like a blood thinner.

It is not a cure, but Elmiron promised to provide some relief to the painful symptoms for the three to eight million women affected from the pain associated with the inflammation or irritation of the bladder. It’s estimated up to four million men may also suffer from interstitial cystitis, which may be due to a defect in the protective lining of the bladder.

Symptoms include a burning sensation and urinary urgency, a feeling of discomfort of pressure in the bladder or lower abdomen, pain during intercourse, and pelvic floor muscle pain.

Now, 24 years after its approval, Elmiron is linked to maculopathy, the most common cause of blindness.

Janssen Pharmaceuticals, a division of Johnson & Johnson, added a warning in June concerning a potential life-altering retinal disorder – pigmentary maculopathy. This was added to the side effects already appearing on the instructions for use (IFU) including abnormal liver function, nausea, diarrhea, and hair loss.

Sufferers usually experience vision loss after at least two years. The vision problems must have onset within a year of stopping the drug or during its use. Damage may stop if caught in the early stages of drug use.

Scientific Studies

Three ophthalmologists conducting a review of patients at Kaiser Permanente in Northern California found about one-quarter of users of Elmiron displayed signs of eye damage. Taking a closer look at 91 patients who had taken an average of 5,000 pills found 22 patients with signs of drug toxicity.

Emory Eye Center in Atlanta, Georgia also noted six patients who were long-term users of Elmiron developed changes to their macula, the part of the eye which allows us to see with detail and clarity.

Lawsuits alleging a failure to warn the public and doctors about the risk of vision problems are now being filed. Tens of thousands of patients may be affected.  Patients who have filed report they are experiencing blurred vision and vision impairment including retinopathy and maculopathy.

Patients with liver issues should consult with their doctor before using the drug.

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.”

Symptoms of Elmiron use may include:

* Dimming vision

* Difficulty reading

* Difficulty adjusting to the light

* Loss in a field of vision

* Loss of night vision

* Difficulty seeing objects that are close

* Blindness

* Halo vision

* a diagnosis of pigmentary maculopathy

*A diagnosis of macular degeneration

* A diagnosis of Macular Retinopathy

* A diagnosis of Retinal Deterioration

* A diagnosis of Pattern dystrophy

LEARN MORE:

American Academy of Ophthalmology news release

FDA Prescribing Information for Elmiron

May 2018, Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium