Pentosan polysulfate sodium, known commonly under the brand name Elmiron, is the only FDA-approved oral therapy for the treatment of interstitial cystitis (IC) – a chronic pain syndrome of the bladder. Recent medical studies have revealed a possible link between longtime usage of Elmiron and the development of serious visual impairments like maculopathy. Over one million Americans suffer from IC, so this means that there is a risk for widespread vision problems caused by Elmiron.
Kaiser Permanente Study on Elmiron Eye Damage
A 2019 study by ophthalmologists at Kaiser Permanente in Northern California analyzed a database of 4.3 million patients. Researchers identified 140 patients who had taken an average of 5,000 Elmiron pills each over a 15-year period. 991 of those 140 patients agreed to participate in an exam in which researches took detailed photographs of the backs of their eyes.
The results of this study were troubling. Clear signs of Elmiron toxicity were discovered in 22 out of those 91 patients. There was a correlation between the amount of Elmiron taken and the rate of toxicity. 11% of the patients took between 500 to 1,00 grams, while 42% took 1,500 grams or more.
About 25% of those who took large amounts of Elmiron had obvious signs of eye damage. Researchers also determined that their eye damage could easily be mistaken for different retinal issues like age-related macular degeneration and pattern dystrophy.
It has not been determined what level of Elmiron usage will lead to damage. Study author Robin Vora recommends that patients who have not shown signs of toxicity undergo retinal damage screenings at least once per year.
People who have experienced symptoms of eye damage have been advised to speak with a urologist or OB/GYN about discontinuing their use of Elmiron. Researchers say that Elmiron-related eye damage can be limited if it’s identified early and the patient stops using the medication.
Legal Options For People With Eye Damage Caused by Elmiron
Pharmaceutical companies have a legal duty to test their products and ensure their safety prior to releasing them to the market. If there are harmful side effects in a type of medication, these companies are required to provide warning labels that notify consumers of these risks. When users of a particular drug suffer from health problems caused by that drug, it’s important to determine if the pharmaceutical company is at fault due to negligence.
In cases where consumers suffer from serious health problems caused by a defective drug, those affected may have grounds for a lawsuit against the pharmaceutical company. If you or a loved one has suffered from vision problems or eye damage after longterm usage of Elmiron, we advise discussing your legal options with an experienced defective drug lawyer.
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