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Overview on Elmiron Lawsuit
Interstitial cystitis (IC) is a condition involving recurring discomfort or pain in the bladder or pelvic region. It’s also known as bladder pain syndrome (BPS), painful bladder syndrome (PBS), and chronic pelvic pain (CPP).
Often associated with urinary frequency and urgency, IC affects between four and 12 million people in the US alone. While the exact cause for the condition remains a mystery, there are effective treatments for this condition, including the use of Elmiron.
Unfortunately, new research reveals that Elmiron comes with dangerous side effects related to vision loss. Have you or someone you know received a diagnosis of maculopathy after using Elmiron medication?
If so, keep reading to find out how this drug can impact your vision over the long-term and what legal recourse you have if you’re already experiencing changes in vision or loss of sight.
Join the community of interstitial cystitis and painful bladder syndrome patients holding the manufacturers accountable for vision damages attributed to long term Elmiron use by asserting your personal injury claim.
Elmiron is a medication used to treat what’s known as a “painful bladder syndrome” or in medical terms, interstitial cystitis. It can be used to treat osteoarthritis in humans, and both elderly dogs or horses. It has also been used as an anticoagulant.
But Elmiron has been linked to causing a severe eye disorder that can lead to blindness. Between 1997 and 2019, there were 100 cases of Elmiron patients who suffered eye disorders reported in the Food and Drug Administration Adverse Event Reporting System (FAERS). Eight of those cases were considered serious, while 22 of them mentioned a variety of forms of maculopathy.
Elmiron Lawsuits Filed by Johnson//Becker, PLLC
- Elmiron Lawsuit Filed by Johnson//Becker, PLLC Over Eye Damage and Vision Side Effects – The lawsuit alleges Janssen Pharmaceutical’s drug Elmiron (pentosyn polysulfate) is the cause of a Connecticut woman’s eye damage and vision loss.
- Johnson//Becker, PLLC Files Additional Elmiron Lawsuits Against Janssen Pharmaceutical For Elmiron Associated Retinal Maculopathy – The Complaint, alleges that Janssen failed to properly warn patients and their physicians about the substantial vision risks associated with use of their drug Elmiron.
- Johnson//Becker, PLLC Files Elmiron Class Action Lawsuit – The class action lawsuit alleges Janssen Pharmaceutical’s drug Elmiron (pentosyn polysulfate) is associated with vision loss and seeks class certification and a medical monitoring fund.
Elmiron Lawsuit & Litigation Guide – Meet The Attorneys
Interested in downloading our Elmiron Litigation Guide? Learn more about the Elmiron Litigation Team at Johnson//Becker and Meet the Attorney and Co-Chair of our Consumer Products and Mass Tort Department.
Talk to Your Doctor About Elmiron Associated Retinal Maculopathy
If you or a loved one has ever taken Elmiron, you should have your eyes examined by an Ophthalmologist. Download our free PDF guide that you can share with your primary care provider, gynecologist, urologist, or ophthalmologist that provides valuable information on the latest research and discoveries pertaining to Elmiron associated retinal maculopathy.
Interstitial Cystitis 101
Very little is know about interstitial cystitis, and yet it disrupts the lives of millions of women in the United States. What’s more, gender is no protection against IC. Men can also get the disease as can individuals of any race, age, or ethnicity.
People with IC complain of chronic symptoms in the urinary tract that persist for six weeks or more. However, some patients have experienced cases lasting more than two years. People with ongoing IC have a low capacity for urine storage and hard bladders.
Contributing factors to IC include a history of bladder infections. Some people who experience symptoms also report other chronic diseases such as fibromyalgia, other pain syndromes, and irritable bowel syndrome (IBS).
IC may be exacerbated by emotional or physical stressors. These factors can lead to a worsening of symptoms.
People diagnosed with IC may also prove more sensitive to certain beverages and foods. The continued consumption of these foods can also lead to IBS flares up or constipation.
The Treatment of Interstitial Cystitis
For a complete list of IC treatments, please visit The National Institute of Diabetes and Digestive and Kidney Diseases
Health Information Center: https://www.niddk.nih.gov/health-information/urologic-diseases/interstitial-cystitis-painful-bladder-syndrome/treatment
Physicians still have much to learn about the causes and treatments for IC. They have found, though, that limiting patient intake of the following foods and beverages helps:
- Artificial sweeteners
- Spicy food
Your doctor may ask you to avoid the consumption of other food items for several weeks to see if your symptoms improve.
Vegetables and fruit rank at the top of the list of foods patients should consume. These foods don’t have an irritating effect on the bladder. What’s more, they contain essential minerals and nutrients vital to fighting the disease.
Interstitial Cystitis Alternative Treatments
Because treating IC proves complex, it may involve many moving parts. What do we mean? Potential treatments include:
- Bladder distention
- Bladder instillations with mixtures such as Heparin, sodium hyaluronate, DMSO, and others
- Surgery to repair Hunner’s lesions (e.g., laser surgery)
- Physical therapy
- Alternative therapies (e.g., guided imagery, energy therapy, acupuncture, massage)
- Injections like Botox
- Neuromodulation, including the use of electrical nerve stimulations
A variety of oral medications are also prescribed to relieve some of the symptoms associated with IC.
Medications Prescribed to Treat IC
A wide range of drugs get prescribed to relieve the symptoms of IC. They include:
- Elmiron (pentosan)
- Narcotic and non-narcotic medications
- Topical medications like amitriptyline, lidocaine patches, and vaginal or rectal diazepam
- Tricyclic antidepressants like imipramine (Tofranil) and oral amitriptyline
- Antihistamines, such as loratadine (Claritin)
- Alpha-blockers (Flomax)
- Immunosuppressants, such as cyclosporine, mycophenolate (CellCept), and mycophenolate mofetil
- Histamine blockers (Tagamet, Zantac, Pepcid)
- Antiseizure medications (Neurontin)
Of the treatments listed above, Elmiron (pentosan polysulfate sodium) is the only FDA-approved oral medication for the treatment of IC. Unfortunately, new studies show correlations between Elmiron and eye problems.
Let’s take a look at how it is believed Elmiron improves IC and what researchers are beginning to learn about its vision-damaging side effects.
Interstitial Cystitis and Elmiron
Researchers don’t know how Elmiron leads to a reduction of IC-related symptoms. Yet, its beneficial impacts are well-documented.
In a double-blind clinical trial with a placebo, Elmiron reduced IC symptoms for 38 percent of patients within three months. Other studies have reported more significant results, including 61 percent of patients seeing a reduction in symptoms.
Researchers still have much to learn about Elmiron. Yet, they theorize the drug helps repair a damaged, “leaky,” or thin bladder surface.
Known as the glycosaminoglycans or GAG layer, it’s made up of a coating of mucus. This layer protects the bladder wall from irritating substances and bacteria found in urine. Researchers theorize that Elmiron functions as a synthetic GAG layer.
That said, the drug’s mechanical action in IC remains largely hypothetical.
The Use of Elmiron
Elmiron has been on the market since the late 1990s. Patients treated for IC with Elmiron typically receive three 100 mg doses per day. Within three to four weeks, many report an improvement in their bladder and pelvic symptoms.
Others report an improvement in symptoms after the first six to nine months. In many cases, doctors have encouraged patients to remain on Elmiron for a minimum of six months. During this time, pain generally diminishes as does urinary frequency.
Many patients have taken the drug for years and even decades, however.
Until recently, the side effects associated with Elmiron were considered relatively mild compared to its ability to help patients suffering from IC. Listed side effects include minor gastrointestinal disturbances and reversible hair loss.
No adverse interactions between Elmiron and other medications have been reported. Since Elmiron gets metabolized in the liver, however, physicians often monitor their patient’s liver function with periodic blood tests.
Elmiron Side Effects
Many doctors view Elmiron as a safe drug with few side effects. Coupled with its successful therapeutic applications with IC, physicians readily prescribe it.
Unfortunately, recent research points to Elmiron’s long-term side effects. These include rare vision problems impacting the retina and macula. The medicine has even been linked to pigmentary maculopathy and macular degeneration.
What are the symptoms associated with pigmentary maculopathy? They include:
- Blurred or blurry vision
- Seeing dark or black spots
- Night vision problems
- Difficulty reading
- Vision disturbances
- Eye pain
- Distorted vision
- Problems adjusting from light to darkness
- Central vision loss
Pigmentary maculopathy is a rare condition only recently linked to Elmiron. Nonetheless, users should consult with their physician about potential side effects. Even if they’re not currently experiencing vision problems.
What’s more, detecting macula irregularities often requires the use of advanced imaging. That means a consultation with a retina specialist. In other words, long-term users of Elmiron may have undetected vision problems related to the drug.
Are you or a loved one who has taken Elmiron now suffering from vision problems? If so, you may qualify to join in an Elmiron lawsuit investigation.
Elmiron and Maculopathy
Maculopathy is a condition that affects the macula, the center part of the retina that has to do with the most sensitive aspects of vision. Damage to this area can cause severe eye disorders and also lead to blindness.
In 2018, the American Academy of Ophthalmology published an article about six patients who experienced pigmentary maculopathy. Between May 2015 and October 2017, the six adult patients at Emory Eye Center taking Elmiron were evaluated for the eye condition. Later in 2019, that number was up to ten patients who were diagnosed with the same condition.
Maculopathy is a general term used to refer to any pathological condition that affects the central portion of the retina– the macula. There are varieties of maculopathy, including:
Age-Related Macular Degeneration – gradual loss of vision that originates in the central field of vision and occurs over time
Cellophane Maculopathy – this is known as a “macular pucker” and is a form of visual distortion. It causes the formation of a thin, transparent layer of scar tissue over the light-receptor nerve cells in the macula.
Malattia Leventinese – sometimes congenital, this is known as Doyne Honeycomb Retinal Dystrophy (DHRD). Small, pale spots that originate in the macula eventually grow into a honeycomb pattern.
Elmiron & Eye Problem Side Effects
“Pigmentary maculopathy of unknown etiology” is what’s used to describe the condition caused by Elmiron. This basically means there is no known cause.
Symptoms to watch out for are:
- Hyperpigmented, dark spots on the retina that can be observed during an eye examination
- Parafoveal pigmented deposits – vision loss may occur because of an abnormal effect on the capillaries and small blood vessels around the macula
- Vitelliform deposits – these are round, somewhat yellow lesions under the macula, also known as adult pattern macular dystrophy
- Retinal pigment epithelium atrophy – this is common with age-related macular degeneration
Other Elmiron side effects may include alopecia (hair loss), gastroesophageal reflux, headaches, skin rash, sleep disorders, bruising, or diarrhea.
The product labeling on Elmiron has never included pigmentary maculopathy.
The First Study Linking Elmiron to Vision Issues
In November 2018, the American Academy of Ophthalmology linked Elmiron with vision problems. This conclusion was based on research by Nieraj Jain, MD., of Emory Eye Center in Atlanta, Georgia, who noticed changes in the macula of six patients.
All six patients had taken Elmiron for about 15 years and displayed the same striking pattern of vision abnormalities. Jain and his colleagues have reported additional cases since the 2018 release of this initial study.
What did patients with vision damage report? Besides problems adjusting to darkness and difficulty reading, they reported:
- Dimming of vision
- Metamorphopsia (distorted vision)
- Problems adapting to darkness
- Paracentral scotomas (areas of the eye where there is vision loss)
This study represented the first ophthalmological examination of the long-term impacts associated with Elmiron. Another study has since further highlighted the potential for vision-related side effects.
The Second Study Linking Elmiron to Vision Issues
A second study released in May 2019 found that Elmiron led to potentially avoidable retinal damage and degeneration. Three ophthalmologists, Drs. Robin A. Vora, Ronald Melles, and Amar P. Patel conducted the study.
After reviewing 4.3 million patient cases at Kaiser Permanente in Northern California, they examined 140 patients who had taken on average 5,000 Elmiron pills over 15 years.
Based on these detailed examinations, they concluded that ocular toxicity resulting from the use of Elmiron was to blame. They also noted that the rate of toxicity increased with the amount of drug consumed.
Of those patients who consumed between 500 and 1,000 grams, 11 percent showed signs of toxicity. As for patients who consumed 1,500 grams or more, 42 percent had marked signs of ocular toxicity.
Researchers found that the drug caused structural changes to the retina’s pigmented layer. (Located at the back of the eye, the retina senses light, permitting us to see).
2020 Update From European Medicines Agency – Pigmentary Maculopathy Warning for Elmiron Patients
1/30/2020 – The European Medicines Agency, an agency of the European Union has issued new guidance on the link between Elmiron and eye damage side effects. More specifically, the Committee for Medicinal Products for Human Use (CHMP) was tasked with gathering medical expert opinions on the potential risk for developing pigmentary maculopathy from Elmiron.
Here are their findings:
- All patients should have an ophthalmologic examination after 6 months of use of Elmiron, at the same time of the regular reassessment of response to treatment with Elmiron.
- If the examination reveals no pathologic findings, the next ophthalmologic examination should be performed regularly at 5 years of Elmiron treatment (or earlier, in case of visual complaints). However, in case of pathologic findings, the ophthalmological examinations should be performed every year.
Therefore, and as proposed by the MAH, it is considered that the warnings on pigmentary maculopathy should be improved regarding the periodicity of the ophthalmological examination.
New Medical Literature Shows Latency of Elmiron Use and Onset of Elmiron Eye Damage
Long-Term Vision Problems
Neither of the studies above addresses whether discontinuing the use of Elmiron could lead to an improvement in retinal disease. However, when damage is caught early, some physicians theorize that symptom mitigation may be possible.
Keep this in mind, though. Late-stage ocular toxicity mimics late-stage dry atrophic age-related macular degeneration. In other words, it can result in permanent vision loss. So, you need to be proactive when it comes to addressing the current use of this medication.
It remains unclear how much Elmiron is too much. Dr. Vora recommends that patients who show no signs of toxicity at the moment should get screened for retina damage every 12 months or more.
As for those who do show signs of toxicity? Vora says they should speak with their urologist or ob/gyn about discontinuing the medication altogether.
Because these studies are so recent, many physicians currently remain unaware of the potential for vision damage. When it comes to speaking with your urologist or ob/gyn, you may be the one who needs to initiate the conversation.
Macular Degeneration and Eye Health
What do patients who have been taking Elmiron need to know about macular degeneration? Also known as maculopathy, macular degeneration is an umbrella term used to refer to any disease impacting the macula.
What is the macula? The central part of the retina.
It’s responsible for color vision, fine detail, and central vision. Damage to this area comes with significant vision impairment.
Three types of macular degeneration seen by ophthalmologists include:
- Cellophane maculopathy (macular pucker)
- Age-related macular degeneration
- Pigmentary maculopathy
Cellophane maculopathy is often linked to age. It results in a thin layer of scar tissue that causes image distortion.
There’s also age-related macular degeneration. It remains the most common version of maculopathy, impacting more than 25 million people in the world.
Finally, there’s pigmentary maculopathy. This rare eye condition involves subtle pigment alterations on the macula. It can also lead to patchy atrophy and other irregularities.
Changes in the macula may be observed and documented by a retinologist. If you or a loved one has maculopathy as a result of taking Elmiron to treat IC, contact an experienced law firm to explore your rights and options.
Hundreds of thousands of individuals have taken Elmiron to treat IC. They’ve been exposed to the risk of potentially permanent vision damage or loss.
If you or someone you know took Elmiron and have suffered maculopathy or other significant vision problems, you may be entitled to compensation.
Patients in Elmiron lawsuits such as Pelczar v. Teva Branded Pharmaceuticals R&D, et. al., have accused the manufacturer of Elmiron, Janssen Pharmaceuticals, with failing to adequately warn consumers of the potential dangers associated with this medicine.
What Does Elmiron-Related Vision Loss Mean for You?
Currently, the prescribing information provided by Janssen Pharmaceuticals lists the drug’s side effects and warnings. Yet, the company fails to include information about macular degeneration or other types of vision loss associated with Elmiron use.
Have you or someone you know experienced eye problems since taking Elmiron to treat a bladder infection? If so, you may have the basis for an Elmiron lawsuit.