Thousands of people taking Elmiron for bladder pain are unaware that their vision loss and eye damage are related to the medication. Many people take Elmiron for years and do not know that the longer they take it the more prone to eye damage they become.
Elmiron is the brand name for Pentosan, which is sodium pentosan polysulfate (PPS). Doctors prescribe this drug to treat pain caused by interstitial cystitis, commonly known as “painful bladder syndrome.” Off-label uses also include osteoarthritis help in humans, as well as in elderly dogs and horses. There are approximately 500,000 users of the name brand medication.
Approved by the FDA in 1995 through the Orphan Drug Act, Elmiron sales continue to climb to over $150 million a year. The FDA did not approve the drug not once but twice. The agency said that the clinical trials had fatal flaws. However, the FDA still approved the drug-using “compassionate use”. In order to approve the drug, the manufacturer needed to create a database for claims.
There are different types of interstitial cystitis and Elmiron won’t work on everyone, however, the label does not warn of this. In fact, 40-60% of those taking the medication have zero pain relief. The peak benefits of the drug happen after one to two years of use. Also, the body only absorbs 6% of the medication. The risk is not worth the benefit.
Elmiron & Eye Damage
In 2018, the American Academy of Ophthalmology published an article about ten patients who experienced pigmentary maculopathy from taking Elmiron. Maculopathy is a condition that affects the macula, the center part of the retina. The retina is the most sensitive aspect of vision. Damage here can cause eye disorders and blindness. The study evaluated ten adult patients taking Elmiron for two years at The Emory Eye Center in Atlanta, GA. All developed maculopathy.
The variety of Maculopathy symptoms the researchers noted were:
- Pigmentary Maculopathy – injury to the coloring of the retina and underlying retinal pigment epithelium (RPE) – inhibits the ability to adapt to light & dark
- Written off as part of the aging process
- Macular degeneration, deterioration of macula portion of the retina
- Retinal hemorrhage – bleeding in the retina (seeing floaters, cobwebs, haze, rapid light flashes, red tint)
- Amblyopia – decreased vision in one eye due to the brain failing to process inputs from one eye to the other aka lazy eye
- Optic Neuritis – temporary vision loss and pain typically in one eye
- Others – distorted vision, blurred, dimming, diminished central visual activity
Also, many Elmiron patients may not even know they have these macular disorders. Instead, they assume their vision is just degrading.
Other Elmiron Side Effects
The other side effects the researchers noticed those who took the drug from over 4 years are:
- Prolonged light to dark adaptation
- Blurry vision while reading
- Metamorphopsia (lines look curvy)
- Central vision loss in advanced cases
- Initial symptoms may present as generalized dimming in vision
- Other visual symptoms (floaters, spots, impaired color vision)
Therefore, if you ever took Elmiron and experienced retinal maculopathy, you may be eligible for compensation to offset your financial, physical, and emotional burdens. Contact us today to set up a free consultation during which we will listen to your story and discuss your legal rights and options. If you choose us to represent you, we will work with you on a contingency fee basis; this means you pay nothing until we have secured compensation for you, either through a jury verdict or settlement.