JAMA Ophthalmology Study on Serious Elmiron Side Effects

Home » JAMA Ophthalmology Study on Serious Elmiron Side Effects
July 20, 2020
Edward Smith

July 2020 JAMA Ophthalmology Study

A new study published in the Journal of the American Medical Association (JAMA) in its July 9, 2020 issue reports that patients must be made aware of the potential long-term risks of Elmiron side effects.  Elmiron® (pentosan polysulfate sodium) is a drug used for the treatment of interstitial cystitis, a painful bladder condition.  Alarmingly, the JAMA study found that the potential long-term consequences of Elmiron use continued beyond the patient’s discontinuation of the use of the drug.  

Risk of Elmiron Side Effects Continue After Usage Stopped

The JAMA piece reported that new data indicates that maculopathy associated with Elmiron use has the potential to continue to evolve after the use of the drug is ceased.  Additionally, in some cases, progressive retinal pigmental atrophy could invade the central fovea years after use of the medication was discontinued.  One of the doctors conducting the study was Neeraj Jain, M.D. from Atlanta’s Emory University.  The study consisted of eleven patients who had taken Elmiron for a number of years in the past for treatment of IC and had also be diagnosed with a retinal disease associated with their use of Elmiron.  One patient of the eleven had stopped the drug approximately 10 years prior to the study.  The purpose of the study was to evaluate the side effects of Elmiron toxicity after use of the medication had been stopped. 

Patients and Doctors Need to Know of Continuing Risks

The study showed that nearly all of the eleven participants demonstrated continued progression of retinal disease. This is an important and startling finding.  Patients who have taken or are currently taking the medication, as well as the doctors who continue to prescribe Elmiron, should be informed that risks do not disappear after discontinuation of use.   The same JAMA Ophthalmology issue featured commentary from several other physicians who expressed concern over the findings and recommendations that physicians advise their patients of the risk of serious Elmiron side effects, including permanent loss of sight. 

A safe dosage amount with regard to retinopathy risk remains unknown, as does safe limits on cumulative dosage and duration of treatment.  Physicians are especially concerned given the observations that vision-threatening maculopathy appears likely to progress despite the cessation of the drug.  They also mentioned the need for formal screening procedures given that pre-symptomatic disease is not easy to detect absent such screening.

Lawsuits Related to Elmiron Side Effects

Earlier this month, a lawsuit was filed in the U.S. District Court for the Southern District of California on behalf of a plaintiff who suffered retinal damage and vision loss after her long-term use of Elmiron.  The defendants include Bayer Healthcare Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Johnson & Johnson, and others.  The lawsuit contains allegations that the defendants involved in the manufacture, development, and sale of Elmiron failed to warn patients, government regulators, and physicians of the serious risk of eye damage, including retinal damage, impaired vision, and maculopathy.

Alternatives to Elmiron

Anyone considering alternatives to Elmiron should consult with their physician before making any changes.  Below is a YouTube video discussing the management of IC through diet.

Sacramento Drug Products Liability Lawyer

I am Ed Smith, a drug product liability attorney located in Sacramento, CA.  Pharmaceutical manufacturers often fail to warn physicians and patients of significant risks associated with the use of their dangerous products.  If you were injured or received a diagnosis of a health condition associated with the use of a dangerous drug product, do not hesitate to call my office at (916) 921-6400 to receive free and friendly advice.  My toll-free number if you are outside the (916) area code is (800) 404-5400.  I also offer an online contact option.

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