Studies have linked the popular interstitial cystitis drug, Elmiron to progressive eye diseases such as retinal maculopathy, retinal pigmentary endothelium injury (RPE), or age-related macular degeneration.
About Elmiron
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.
Low Efficacy
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 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.
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 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)
Elmiron Study Fallout
Since the initial study only followed ten people, those in the medical community wondered how many other people who took Elmiron experienced vision problems. Plus, the study didn’t determine how long a patient needed to be on Elmiron before eye damage occurred, the dosage needed for an injury, the progression of damage after discontinuing, and if injuries would become better after halting the drug.
Doctors in Kaiser in Oakland, CA called in patients taking Elmiron for bladder pain. They found that 24% of the 91 people in their database had retinal Maculopathy and pigmentary damage, which causes damage to their eyesight. IC Network also began to dig into this study and found almost 54% of 1,604 patients taking Elmiron developed the retinal disease.
Harvard Medical Study
In October 2019, Dr. Rachel M. Huckfeldt, an ophthalmologist that specializes in retinal degenerations at Harvard Medical School, published one of the most concerning case reports regarding the dangers of Elmiron in the Journal Ophthalmic Surgery Lasers and Imaging Retina. Her report followed a female eye patient for eight years. The woman began seeing Dr. Huckfeldt when she began experiencing blurry vision and difficulty seeing at night. Over the course of six years, the patient has substantially worst degraded vision. The doctor could not figure out the cause. Even when she returned two years later, her vision continued to decline. Then, Dr. Huckfeldt asked the patient if she took Elmiron. She had. A urologist prescribed a 200 mg low-dose of it after diagnosed with interstitial cystitis. However, she wasn’t still taking the medication. In fact, she stopped using the drug years ago (the second year she saw Dr. Huckfeldt.)
Therefore, all patients who took Elmiron regardless of when are at risk for retinal maculopathy.
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.
Current Litigation
Currently, there is a product liability lawsuit for failing to warn of the dangers of Elmiron. The complaint, case No. MID-L-003646-20, was filed on June 9, 2020, in the Superior Court of New Jersey, Middlesex County, naming Janssen Pharmaceuticals and Teva Branded Pharmaceutical Products R&D as defendants. On March 26, 2020, there is another case filed in the United States District Court for the District of Connecticut. Defendants include Teva Branded Pharmaceuticals and Janssen Pharmaceuticals. Also, there is another case in the US District Court for the Eastern District of Pennsylvania filed on May 6, 2020. It seeks class certification to establish a fund to be used for medical monitoring of patients using Elmiron to monitor the status of their vision.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects to your entire life. You may also be entitled to compensation for their injuries and damages. The types of losses include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
If a person dies from complications from a drug, family members may also be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If a jury finds the conduct of a drug company in manufacturing and selling the drug to be highly reckless, they may award punitive damages to punish the company. Also, this deters similar conduct in the future. If you developed melanoma after taking Viagra, please speak to us to learn more about your rights.
Free Consultation
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.
