UNITED STATES—Elmiron, a medication that has been commonly prescribed to treat a bladder condition, could be harmful to the eyes. This drug has been given to patients with bladder problems for decades, but researchers have recently found that the medication is harmful to the retina, which is the tissue in the rear section of the eye that senses light and allows you to see.
Elmiron, or pentosan polysulfate sodium, was assessed by a Northern California ophthalmologist team at Kaiser Permanente. The ophthalmologists discovered that around one-fourth of the patients who took Elimron eventually developed significant eye damage.
The study also revealed that Elmiron’s toxicity could be mistaken for pattern dystrophy or macular degeneration, two common retinal conditions that often occur with age. The study results were first presented at the 2019 Annual Meeting of the American Academy of Ophthalmology.
Why Is Elmiron Prescribed?
Elmiron is used to treat interstitial cystitis. This condition can cause long-term bladder and pelvic pain. About 1 million people in the U.S. have interstitial cystitis, and most of these individuals are women. Elmiron is the only medication approved by the FDA to treat this condition, and it has been a go-to treatment for interstitial cystitis for decades.
This means that hundreds of thousands of people have taken the medication and could be experiencing vision problems because of it.
In 2018, Nieraj Jain, M.D. from Emory Eye Center reported that six individuals who took Elmiron for 15 years were undergoing unusual macular changes. The macular is the center of the retina and is responsible for delivering clear vision. No other factors in the medical record of these patients could explain the changes, which led Dr. Jain and his associates to conclude that Elmiron causes retinal damage.
Kaiser Permanente ophthalmologists Drs. Robin A. Vora, Amar P. Patel, and Ronald Melles took Dr. Jain’s warning to heart and observed their patients to determine if the connection between Elmiron and retinal damage was substantial.
The team discovered that one female patient was being treated for retinal dystrophy but had been misdiagnosed. This led the doctors to assess Kaiser’s entire patient database, which consisted of 4.3 million individuals.
The ophthalmologists sifted through the medical records of 140 patients who took about 5,000 Elmiron pills each over 15 years. Nearly all those patients (91%) agreed to be examined by the doctors. The ophthalmologists divided the images of the patients’ eyes into three groups: normal, possibly abnormal, and definitely abnormal.
The final test results revealed that 22 of the 91 patients showed signs of Elmiron toxicity. The toxicity increased based on the amount of Elmiron consumed. The toxicity rate was 11% for patients who took 500 to 1,000 grams of the drug but jumped to 42% in patients who took 1,500 grams or more of Elmiron.
Dr. Vora deemed the situation “unfortunate” since there is no other cure for interstitial cystitis currently. The patients were given Elmiron because they were under the impression that the medicine had little to no side effects or risks. For many patients, their dosage increased over the years, which led to more long-term eye damage.
How Much Elmiron Is Too Much?
Dr. Vora asserts that it’s not clear how much Elmiron is too much. However, he recommends that people on this medicine be screened annually, even if they don’t show any toxicity symptoms. Patients who do show toxicity signs should talk to their OB/GYN or urologist about safely stopping the medication.
If toxicity is detected early, there is a greater chance that retinal damage can be mitigated. In the late stages of toxicity, macular degeneration could lead to permanent loss of vision.
Elmiron, a popular prescription drug designed to treat pain in patients living with interstitial cystitis, is now linked to high toxicity levels and irreversible eye damage. The findings are not surprising since one in five recently FDA-approved prescription drugs is tied to severe side effects, and prescription drugs (even the ones properly prescribed) are now the 4th leading cause of death in the U.S.A.
Unfortunately, Elmiron is the only effective drug against interstitial cystitis, so patients need to be careful when taking it. What is more, the medicine might cause irreversible vision loss if its side effects are not properly mitigated.
So, patients who have been injured by this drug might be entitled to significant compensation for their vision problems. If you believe you are one of those patients, talk to a drug injury lawyer today. (Source: https://www.pintas.com/practice-areas/drug-injury-lawyer/).
About the Author
Kyle Hambright is a passionate writer proudly representing Pintas & Mullins Law Firm. He has focused his legal career on personal injury cases, and throughout his practice, Kyle has helped people from all walks of life. This determination transpires in his writings as well. His articles translate the complex web of legal jargon into accessible text. Readers not only gain a firm grasp on theory, but they also learn how to put it into practice.