Get Your Elmiron Lawsuit Reviewed for Free by Skilled Defective Drug Attorneys
Parker Waichman LLP is reviewing cases involving severe side effects affecting vision, such as blindness and vision loss, suffered by patients who have been prescribed Elmiron (pentosan polysulfate sodium) who are now interested in filing lawsuits to recover monetary compensation for Elmiron eye damage.
If you or a loved one have been prescribed Elmiron and suffered eye damage such as blindness or vision loss, protect your legal rights by contacting Parker Waichman today at 1-800-YOUR-LAWYER. We won’t charge you for anything unless you receive a settlement from your Elmiron lawsuit. Click here for Elmiron Timeline.
What Is Elmiron?
Elmiron is a commonly prescribed weak blood thinner (anticoagulant). Elmiron is used to treat bladder pain or discomfort caused by Cystitis of the bladder. Elmiron contains the active ingredient pentosan polysulfate sodium (PPS). According to ICHelp.com, Elmiron is the only medication approved by the U.S. Food and Drug Administration Interstitial Cystitis (also known as bladder pain syndrome or IC/BPS).
Interstitial Cystitis (Bladder Pain Syndrome or IC/BPS)
Interstitial Cystitis is a debilitating, chronic and rare urogenital disease that presents symptoms such as bladder pressure, pain in the lower back, lower abdomen, or pelvic area, Hunner’s lesions or glomerulations in adults feeling moderate to severe pain, urinary urgency and micturition frequency. In patients suffering from Interstitial Cystitis, the patient’s pelvic nerve sends a signal to the brain that creates an urgency to urinate. However, in severe IC cases, the patient may attempt to urinate approximately 40-60 times a day with small amounts of urine observed. IC is commonly mistaken as a bladder infection, but IC is not an infection. It is estimated that IC affects 2.7% to 6.53% of older women in the United States. Patients suffering from Irritable Bowel Syndrome (INS), Fibromyalgia, or allergies are more likely to experience IC.
The Contributing Factors That Lead to Interstitial Cystitis
According to a MarketWatch.com press release, the known contributing factors that may cause interstitial Cystitis are
- a defect of the epithelium layer of the bladder,
- leaking epithelium allows toxic agents in urine to irritate the bladder wall.
- an autoimmune reaction,
- or allergy.
Diagnosing Interstitial Cystitis
Interstitial Cystitis is commonly diagnosed by performing a bladder ultrasound, cystoscopy, urine analysis, bladder stretching, a biopsy of bladder and urethra, and performing culture on the patient’s prostate fluid. There are many treatment options that provide relief for the symptoms of Interstitial Cystitis. At the release of this page, there is no cure for Interstitial Cystitis.
Market for Interstitial Cystitis Expected to Generate Greater Revenue Share Between 2017 and 2025
Interstitial cystitis (IC) is a chronic and debilitating bladder disease. IC is commonly referred to as “painful bladder syndrome,” according to an article appearing on The Express Wire. Symptoms of IC often include pressure and pain in the bladder. However, the person suffering from IC could experience milder pain radiating to his or her lower abdomen area, pelvic region, and lower back. As with most diseases, patients with IC experience pain described as mild to severe, depending on the person’s tolerance for pain, among other factors.*
The IC patient’s pelvic nerve could be the source of the condition. The patient’s pelvic nerve misinterprets signals from the bladder to the brain. The result is a frequent feeling to urinate; however, the bladder produces a small volume of urine. While most healthy people urinate about seven times per day, the patient with IC might try to go to the bathroom between 40 and 60 times daily. The perception that the patient with IC needs to urinate is a tremendous disruption in one’s daily life.
Many IC sufferers confuse IC symptoms with those commonly associated with a bladder infection. IC is not a bladder infection, however. Doctors have determined that the IC patient has a defect of the epithelium layer of the bladder. The patient’s leaking epithelium layer permits the toxic components in urine to irritate the bladder wall. The irritation of the bladder wall creates a false sense of urgency to urinate.
Doctors have identified additional health factors that could contribute to developing IC. Contributing factors include genetics, autoimmune reactions, allergies, or infections. Doctors admit that they do not fully understand how these factors might contribute to the onset of IC.
Doctors use various diagnostic tools to arrive at a diagnosis of IC for a patient. Diagnostic tools include urinalysis, a biopsy of the bladder and urethra cells, cystoscopy, prostate fluid cultures, and bladder stretching.
Currently, there is no cure for IC. Through extensive research, drug manufacturers have developed medication and therapies that provide a measure of relief from IC symptoms.
Since a cure is not known at this time, physicians prescribe five stages of therapy to relieve the patient’s symptoms. The first stage is physical therapy. Next, the patient will take oral medications like amitriptyline, which helps reduce bladder spasms, and Elmiron (pentosan polysulfate sodium) to reconstruct the wall lining the patient’s bladder. Doctors may prescribe additional medications like steroids to reduce inflammation and prescribe hydroxyzine or dimethyl sulfoxide to help block pain in the most severe cases.
If the primary course of medicinal treatments proves unsuccessful, then doctors will prescribe neurostimulation as the third stage of treatment. Neurostimulation includes therapies like transcutaneous electrical stimulation and sacral nerve stimulation.
The fourth phase of IC treatment involves a course of cyclosporine. Cyclosporine is a medication designed to change the bladder’s immunity response. Finally, the fifth stage — and most invasive — is a surgical intervention or bladder detention.
Doctors have two options when prescribing medication for IC: Elmiron (pentosan polysulfate sodium) and a drug called Rimso-50 (dimethyl sulfoxide). Elmiron has been “off-patent” for ten years. The U.S. FDA approved Elmiron on September 26, 1996, but its patent expired in January of 2010. Rimso-50 is also off-patent and has been since 2002.
As a result of the only two prescription drugs with no valid patents, the market for new prescription medications is open to new entries. Since doctors’ options are limited to antidepressant drugs like amitriptyline, antihistamines like hydroxyzine, or analgesics medicines, both opioid and non-steroidal, the market for treatment is ripe for a new entry.
Problems developing new medicines to combat IC persist. Drug companies have experienced pushback when developing new IC treatments because of the limited efficacy of the drugs and the compliance of the drugs now available. People facing IC do so with a lack of greater awareness of the need to develop new medications as well. Companies do not fully understand the growing need for new drugs to reach the market to help people with IC. Still, some drugs are in the early stages of development. Companies with drugs in the pipeline have produced only a few molecules up to this point. Consequently, drug makers could find entry into the space to be a tremendous opportunity if they could develop a safe drug that works.
Drug companies must assess whether they wish to enter the market, which could be divided among segments: North America, Asia-Pacific, Europe, and ROW, or Remainder of the World. Drug manufacturers could find a lack of available products enticing; however, the diagnosis rate for IC is low.
Notwithstanding those challenges, some companies have entered the market for new IC drugs. Some players in the IC space are well known and well-respected companies like Merck & Co., Inc. and Allergan, Plc. Several smaller drug manufacturers include Kytogenics Pharmaceuticals, Xigen SA, Urigen Pharmaceuticals, Inc., Lipella Pharmaceuticals, Inc., Aquinox Pharmaceuticals, Inc. Astellas Phamra, Inc. UCB SA, and Bellus Health, Inc.
Does Elmiron Cause Pigmentary Maculopathy?
Recent medical research has linked being prescribed Elmiron with an increased risk of developing an eye disease known as maculopathy. The specific Elmiron eye disease cited is called pigmentary maculopathy, which affects the retina of the eye. However, Elmiron has not yet been recalled by the Food and Drug Administration (FDA).
If you or a loved one is suffering from pigmentary maculopathy and has been prescribed Elmiron, contact Parker Waichman at 1-800-YOUR-LAWYER for a free personal injury case review.
Startling New Elmiron® Drug Label Warns of “Retinal Pigmentary Changes” Risk Factor
June 16, 2020 – FDA – Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, has made a startling admission that a cumulative dose of its Elmiron® (pentosan polysulfate sodium) medication “appears to be a risk factor” for side effects such as “Retinal Pigmentary Changes.” Elmiron® is a bladder pain medication sold throughout the world. Patient labeling for Elmiron® that is sold within the United States never listed serious warnings or health risks under the “Warnings” section of its patient labeling. The only warnings included in the patient labeling prior to this patient labelling change included such benign side effects as diarrhea, nausea, hair loss, and headaches. On June 16, 2020, the FDA approved an Elmiron® label change now lists “Retinal Pigmentary Changes” as a risk factor under the “Warnings” section of the patient information labeling.
Retinal changes, such as Pigmentary Maculopathy, were identified as a risk factor in the long-term use of Elmiron®. Health Canada has required the before-mentioned warnings for Elmiron® starting in October 2019. In June 2019, the European Medicines Agency demanded Janssen Pharmaceutical Companies list a similar health warning on all Elmiron® patient labeling. Janssen now warns that these retinal changes have been observed with short-term use as well.
When a medication has been linked to severe side effects such as Pigmentary Maculopathy or Retinal Pigmentary Changes, the FDA will require a drug to include warnings of these potential risk factors and serious health effects in the form of a “black box warning.” A black box warning is the FDA’s most severe warning for drugs and medical devices that are available for sale in the United States. A “Black box warning,” or boxed warning, alerts the public and health care providers to significant and serious side effects such as injury or death.
Parker Waichman LLP is a nationally recognized plaintiff´s law firm who has been on the forefront of litigation involving defective drugs, products, and medical devices that harm the public. Our firm has successfully represented clients who have sustained severe and permanent eye injuries for over a decade. If you or a loved one have been prescribed Elmiron® and you or your loved one suffered harm, contact us today without delay to receive your free case review. There is no obligation to discuss your case with one of our experienced, and caring attorneys. Our firm represents clients in Elmiron® lawsuits on a contingency fee basis. This means there will be no fee for our firm’s services unless our client receives compensation from their Elmiron® lawsuit. Call us today at 1-800-YOURLAWYER (1-800-968-7529) to discuss your case and learn how you could recover monetary compensation for your Elmiron® eye injury.
Elmiron, Blindness, and Other Symptoms: Links Between Elmiron and Eye Disease
Maculopathy is a disease that affects the macula. The macula is the part of the retina that is responsible for producing accurate and highly sensitive vision. The symptoms of the Elmiron eye disease, pigmentary maculopathy, may be mild or severe depending on the amount of retinal damage that has occurred. Common signs and symptoms of maculopathy include:
- Difficulty reading
- Difficulty acclimating to dim lighting
- Symptoms that mimic pigmentary pattern dystrophy
- Partial or full loss of vision
- Retinal toxicity
- Other vision-related dysfunction
The link between Elmiron and eye problems like maculopathy was first reported back in 2018. Researchers at the Emory Eye Center at the Emory School of Medicine in Atlanta, Georgia, published an alert alleging Elmiron’s link to retinal injury (maculopathy). The alert followed a study conducted by Emory researchers who found the retinal disease in young adults who were diagnosed with interstitial cystitis, also known as bladder pain syndrome (BPS). Bladder pain syndrome is chronic pain that affects the bladder.
Maculopathy is a disease that typically presents itself in elderly patients. However, the study found that patients in their 20s who were taking daily doses of Elmiron began having difficulty reading and developed near-vision problems by age 30.
Parker Waichman LLP Sues Major Pharmaceutical Companies on Behalf of Client Who Suffered Permanent and Irreversible Vision Loss After Taking Elmiron®
PORT WASHINGTON, N.Y. — Parker Waichman LLP sued Bayer Healthcare Pharmaceuticals, Inc., Johnson & Johnson, Janssen Pharmaceuticals, Inc., Ortho-McNeil Pharmaceuticals, Inc., and a host of other drug companies on behalf of a woman from San Diego who took Elmiron® for a long time and now has permanent vision loss, among other eye problems. Parker Waichman LLP filed a complaint in the United States District Court for the Southern District of California. The docket number is 20CV1266 JM BLM, according to apnews.com. The plaintiff alleged in her case against Bayer Pharmaceuticals, Inc., et al., that Elmiron® damaged her retinas, caused pigmentary maculopathy, and resulted in permanent vision loss.
Doctors prescribed Elmiron® for patients, like the plaintiff in the case against Bayer Pharmaceuticals, Inc., and others, who battled interstitial cystitis. Interstitial cystitis is often referred to as “painful bladder syndrome.” The plaintiff is one of many people who have sustained devastating injuries to their eyes and vision impairment, as well as other eye ailments after taking Elmiron®. The plaintiff asks the court to assess damages against the rug companies for losses such as pain and suffering, mental anguish, lost wages, lost earning capacity, and medical expenses, among other damages.
The plaintiff alleges in her lawsuit that the defendant drug companies caused her injuries by failing or refusing to develop, manufacture, and sell a safe prescription drug. Additionally, the plaintiff alleges in her lawsuit that the defendants knew about the potential vision loss and eye injuries caused by Elmiron®, but still failed to warn, educate, advise, and alert physicians, the FDA, and patients about the possible side effects that could render a patient blind.
The depth of the defendant drug companies’ deceit runs deep. The investigation the plaintiff’s lawyers conducted into Elmiron® revealed the studies the defendant drug makers used to convince regulators that Elmiron® was safe and effective do not support the companies’ assertions. Instead, the studies indicate that Elmiron® is an effective treatment for interstitial cystitis. Subsequent clinical trials determined that Elmiron® was about as effective as a placebo for treating interstitial cystitis.
The defendant drug manufacturers have not responded to the allegations.
How Do I Know if I Qualify for an Elmiron Lawsuit?
Call the defective drug attorneys at Parker Waichman at 1-800-YOUR-LAWYER and we’ll review your potential case for free. We have been litigating eye damage cases caused by defective medical devices and pharmaceuticals for more than a decade, and we can help you determine if you should pursue a legal claim over the harmful Elmiron side effects you’ve experienced.
Why Choose Parker Waichman
for Your Elmiron Lawsuit?
When you choose to work with us for your defective drug lawsuit, lawyers with vast experience litigating and winning these types of cases will go to work for you. We have the litigation resources and expertise to effectively represent victims of defective pharmaceuticals that caused eye damage in their fight against large drug manufacturers. Our law firm strives to provide our clients with exemplary legal services based on tenacious advocacy in the pursuit of the fullest recovery possible.
The reputation of Parker Waichman as an industry leader is evinced by a wide array of accolades and awards, which include:
- Martindale-Hubbell’s highest peer-review rating, “AV Preeminent”
- Lawdragon’s highest ranking of “5 Dragons”
- Rating of 9.8 out of 10 by AVVO
- Inclusion in Best Lawyers, an honor based on extensive peer review
Founding partner Jerrold S. Parker’s list of honors is also extensive:
- Award for outstanding service in New York City and the community at the New York Families for Autistic Children’s Awards Ceremony
- Proclamation from the New York City Council, which gave him a Citation of Honor
- Proclamation from the U.S. House of Representatives, signed by Congress
- Congressional Achievement Award in recognition of his outstanding and invaluable service to the community from the U.S. House of Representatives, signed by Congressman Gregory W. Meeks
- Citation from the New York State Assembly, signed by Assemblywoman Audrey I. Pheffer
- Proclamation from the New York State Senate, signed by state Sen. Serphin R. Maltese, for his outstanding service to the community
These acknowledgments and awards are just a few of the prestigious honors that have been bestowed on Parker Waichman attorneys and staff, solidifying not only our reputation as one of the most outstanding personal injury law firms in the United States, but as a law firm that cares about others.
Don’t Delay: File Your Defective Drug Injury Claim Against the Makers of Elmiron
The time you have to recover compensation for Elmiron eye damage is limited by law, so it’s important to act quickly. You can count on Parker Waichman to handle your case promptly and professionally: We’re a nationally recognized defective drug and medical device litigation law firm with vast experience representing individuals harmed by defective medications. Parker Waichman has helped clients to collect more than $2 billion in compensation, and our attorneys will fight hard for you or your loved one. Our product liability litigators have the experience to take on the big pharmaceutical companies on your behalf and are prepared to fight for compensation for those who have had experience with Elmiron and eye issues.
If Elmiron has harmed you or a member of your family and you are interested in filing a lawsuit to recover monetary compensation, contact Parker Waichman by calling 1-800-YOUR-LAWYER (1-800-968-7529) for a free case review today.