The manufacturer of Elmiron, Johnson & Johnson has never placed warnings on Elmiron about eye disease, yet the company has known for 20 years the dangers. It wasn’t until Harvard, Emory and other medical studies started exploring Elmiron eye damage that the company addressed the side effect.
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.
Approved by the FDA in 1995 through the Orphan Drug Act, Elmiron sales continue to climb to over $150 million a year. There are approximately 500,000 users of the name brand medication.
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.
Johnson & Johnson Knew the Risk
The manufacturer of Elmiron, Johnson & Johnson has never placed warnings on Elmiron about eye disease. However, the company knew the dangers since its 1992 pre-approval study. The study showed patients with ophthalmologic problems. Instead of addressing this, they removed those participants. Emory found 2,400 patients in the clinical trial who took Elmiron for up to 4 years and suffered vision and eye-related problems.
Elmiron and Maculopathy
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.
Therefore, the variety of Maculopathy symptoms the researchers noted were:
- Age-related macular degeneration – a gradual loss of vision that originates in the central field of vision and occurs over time
- Cellophane – a form of visual distortion that causes a formation of a thin, transparent layer of scar tissue over the light-receiving nerve cells in the macula.
- Malattia Leventinese (Doyne Honeycomb Retinal Dystrophy (DHRD) – small, pale spots in the macula that grow in a honeycomb pattern.
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 in the study are:
- Change in eye color
- Blurred vision with central vision loss
- Difficulty reading
- Poor light to dark adaption
- Dark spots in vision
- Straight lines appear curved
- Muted, less vivid colors
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.