Have you or a loved one been diagnosed with pigmentary maculopathy or other vision problems after taking prescription drug Elmiron?
If so, you could be entitled to compensation for your eye injury, including medical bills, lost wages, reduced quality of life, and more.
Find out more about filing an Elmiron lawsuit with the help of a personal injury attorney at Patterson Legal Group.
What Is Elmiron, and What Is it Used to Treat?
Elmiron, also known as pentosan polysulfate sodium, is a prescription medication intended to treat bladder pain associated with a medical condition called interstitial cystitis (IC). IC may also be referred to as painful bladder syndrome. Interstitial cystitis is a chronic bladder condition primarily affecting women, although men may also suffer from IC.
- Common symptoms of painful bladder syndrome in women include pelvic pain, frequent urination, pain during or after sex, and unexplained pain or pressure in the urethra, vagina, the area above the pubic bone, inner thighs, lower abdomen, lower back, or groin area. Symptoms may come and go, worsening during menstruation or during times of stress.
- In men, commonly reported symptoms of IC include unexplained pain or pressure in the penis, testes, scrotum, the area above the pubic bone, lower abdomen, lower back, or groin area. Men may also experience pain after ejaculation and frequent, painful urination.
Elmiron is thought to work by adhering to the bladder’s mucosal lining and preventing irritating urine solutes from reaching the bladder wall and causing pain. Pentosan polysulfate sodium is the only oral medication that has been approved by the Food and Drug Administration (FDA) to treat the pain and discomfort associated with interstitial cystitis. The prescription drug has been on the market since it was approved by the FDA in 1996.
What Are Possible Side Effects of Taking Elmiron?
As with many prescription medications, taking Elmiron may have side effects. Prior to June 2020, side effects listed on Elmiron’s packaging included hair loss, diarrhea, nausea, bloody stool, headache, rash, stomach upset, abnormal liver function, dizziness, and bruising. Because the medication acts as a weak anticoagulant, bleeding is another possible side effect.
Between May 2018 and January 2020, multiple studies were published by opthamologists exploring the connection between long-term usage of Elmiron and instances of pigmentary maculopathy and other retinal diseases.
The results of these studies caused the maker of Elmiron, Janssen Pharmaceuticals, to add additional warnings to Elmiron packaging, patient information, and its website regarding the risk of pigment changes in the retina of the eye after prolonged use of Elmiron. As of June 2020, Elmiron now lists the following additional side effects related to the drug: difficulty reading, slow adjustment to low or reduced light environments, and blurred vision.
What Is Retinal Pigmentary Maculopathy?
Retinal pigmentary maculopathy is a unique type of maculopathy that appears to only affect those who have taken Elmiron for a prolonged period of time (generally three years or more, although symptoms have occurred earlier in some patients). Maculopathy involves the macula, a small area in the center of the retina responsible for allowing the eye to clearly see the details of objects in front of it. When the macula is damaged, vision loss can occur.
Retinal pigmentary maculopathy is a type of maculopathy caused by hyperpigmentation of the macula. This hyperpigmentation is believed to be caused by the buildup of yellow or orange deposits, which have been linked to the use of pentosan polysulfate sodium. Symptoms of retinal pigmentary maculopathy include dimming vision, difficulty adjusting to low lighting or darkness, difficulty seeing objects up close, trouble reading, and blind or blurry spots in your vision.
A subsequent study published in the journal Ophthalmic Surgery, Lasers and Imaging Retina found that this type of maculopathy may be irreversible long after the affected person stops taking Elmiron.
Is There a Recall on Elmiron?
As of May 2021, there have been no recalls on the prescription drug Elmiron, in spite of its purported risk of macular degeneration and vision loss. Although Janssen Pharmaceuticals and the FDA both published the warning about possible pigment changes in the eye while taking Elmiron, nothing else has been done by either entity. The FDA has not issued any further statements about the safety of pentosan polysulfate sodium.
Have There Been Any Elmiron Lawsuits?
As of May 2021, there are over 200 Elmiron lawsuits pending in federal and state courts in the U.S. That number is expected to grow considerably as more studies continue to expand public awareness about the potential for Elmiron to lead to irreversible vision loss.
Elmiron lawyers allege that Janssen Pharmaceuticals did not properly warn consumers of the potential of developing retinal pigmentary maculopathy and other irreversible eye damage while taking Elmiron. Since the warning about possible retinal damage was not issued until June 2020, thousands of people who could be at risk of developing this side effect were not adequately informed of those risks prior to using this unsafe product.
Am I Eligible to File an Elmiron Lawsuit?
If you or a loved one took Elmiron as prescribed by a doctor and later developed the following eye problems, you may have grounds to file an Elmiron lawsuit:
- Blurred vision
- Halo vision
- Unilateral or bilateral blindness
- Compromised night vision
- Paracentral scotoma
- Degenerative maculopathy
- Retinal pigmentary maculopathy
- Other vision impairment problems
How an Elmiron Lawyer Can Help
The long-term effects of retinal damage may include disability, lost income, and reduced quality of life, in addition to pain and suffering. If you took Elmiron and suffered from eye damage or vision problems as a result, an experienced Elmiron lawyer can assist you in filing a claim against Janssen Pharmaceuticals.
In doing so, you may be able to secure significant financial compensation and hold the makers of Elmiron accountable for their actions, thus preventing further injury to interstitial cystitis sufferers who are still being prescribed pentosan polysulfate sodium.
To get in touch with our dedicated legal team, contact Patterson Legal Group 24/7 at (888) 687-2400. Online representatives are also standing by via LiveChat to answer your questions and arrange your free case review. Our complimentary initial consultations are risk free. Should you decide to move forward with your case, we can help advise you on the next steps to take.
Elmiron cases will be referred to Lerner and Rowe.