Elmiron Vision Loss Injuries
Elmiron is the brand name for the prescription drug pentosan polysulfate sodium (PPS). Doctors prescribe PPS to treat Interstitial Cystitis (IC), a chronic bladder condition.What is Interstitial Cystitis (IC)?
Interstitial cystitis (IC) is an incurable bladder condition. IC mainly impacts women, causing pain and pressure in the bladder area.
The intensity of IC symptoms varies from person to person. Symptoms can also flare-up in response to triggers such as stress, exercise or other activity. Common symptoms can include:
- Pelvic pain, sometimes chronic
- Persistent or urgent need to urinate
- Frequent urination, often in small amounts
- Pain or discomfort while the bladder fills
- Pain during sexual intercourse
IC symptoms may resemble those of a chronic urinary tract infection (UTI). This can lead to a misdiagnosis. IC is also sometimes called Bladder Pain Syndrome (BPS). Although Elmiron has been prescribed for IC, it is not the only treatment.What is Elmiron?
Janssen Pharmaceuticals distributes Elmiron in the United States. Elmiron is the brand name of pentosan polysulfate sodium (PPS). The FDA first approved Elmiron in 1996.
Pentosan Polysulfate Sodium (PPS) is part of a family of anticoagulant drugs known as low molecular weight herapins. While many anticoagulant drugs in this category are used as blood thinners, Elmiron is used to treat IC. As a medication, PPS seems to protect damaged areas of the bladder wall from irritants.Does Elmiron Cause Eye Injury?
Recent studies link long-term Elmiron use to maculopathy, also known as macular retinopathy. Specifically, Elmiron use has been associated with pigmentary maculopathy.
In the medical studies, a substantial percentage of prolonged Elmiron users showed signs of serious eye damage. One study estimated close to 25% of Elmiron users suffered eye damage.
Researchers are continuing to study Elmiron and how it may damage your eyes. Studies have documented that damaged eyes show over-pigmentation and yellow-orange deposits in the retinal pigment epithelium. This layer of cells in the retina serves several functions such as light absorption.
As scientists only recently discovered this new maculopathy, many prior patients may have been misdiagnosed with another condition. These misdiagnosed conditions may include age-related macular degeneration or pattern dystrophy. If you were an Elmiron user previously diagnosed with one of these conditions, you should consult your physicians.What are Common Symptoms Of Pentosan Polysulfate Maculopathy?
Patients in Elmiron studies report blurred vision, delayed adaption of vision in low light, and metamorphopsia. Metamorphopsia is a retinal issue that causes lines to appear curvy or rounded. You should consult your physicians if experiencing any of these symptoms.What is the Status of Elmiron Research?
Because drug companies may have withheld disclosure of the risks for years, doctors were unaware of the danger. Doctors and their patients innocently assumed the drug was safe for use. This is a common issue we’ve discovered in many of our past dangerous drug and defective medical device cases. In many of those other cases, investigations revealed the drug makers knew the dangers of their products but continued to market them (sometimes for years) without disclosing the information to our FDA, prescribing physicians or innocent patients.
Medical professionals have reported serious patient complications concerning Elmiron for years. Despite these adverse events, the drug’s manufacturers and distributors continued to sell the medication to unsuspecting patients in Alabama and across the United States.
In May 2018, scientists at Emory Eye Center in Atlanta published a case study report raising serious questions about the safety of Elmiron. The Emory physicians documented significant pigmentary maculopathy in observed patients. In the Spring of 2019, Emory Eye Center published a second case study which again discussed issues of pigmentary maculopathy.
In 2019, Kaiser Permanente conducted a study of 4.3 million patients. The patients showed clear evidence of this specific maculopathy, which researchers believed to be associated with Elmiron exposure.
Other studies have reached similar conclusions that Elmiron use leads to pigmentary maculopathy. In 2019, Harvard Medical School published a study after following one of its patients. In April 2020 the Canadian Ophthalmological Society published a study concluding Elmiron may pose a significant risk of macular toxicity. Studies indicate Elmiron is highly toxic to retina tissue.
In 2019, the Elmiron label in Canada was amended to include information about the risks. Yet, the drug maker continued to market the medication to innocent American patients without additional warning. Our FDA did not act in 2018 or 2019 when research studies raised serious injury risk questions. Our FDA delayed its action despite ongoing research results. The FDA finally added a new label warning in June 2020 alerting doctors and their patients to the risk of serious vision side effects. The new label includes information about the risks of retinal pigmentary changes and maculopathy. It’s too late for many injured patients.
At the Blackwell Law Firm, we are continuing to follow this medical research closely. In light of the current findings and updated warning label, we believe medical professionals will be closely studying this drug.Can I File an Elmiron Eye Injury Case? How Blackwell Law Firm can Help
The Blackwell Law Firm is currently investigating individual Elmiron personal injury cases. We are looking at potential personal injury cases with the following criteria:
- Elmiron use on a daily basis for a period of 6 months or longer; and,
- After using Elmiron, you suffered vision problems with a diagnosis of one of the following:
- Maculopathy / Macular Retinopathy
- Retinal Dystrophy
- Age-Related Macular Degeneration
- Other Retinal Conditions
Injured patients are beginning to file Elmiron cases across the United States. As the number of cases increases, they are likely to be consolidated for pre-trial purposes into what is commonly known as a multi-district litigation (MDL) proceeding before a single federal judge. MDL proceedings are common in defective drug and medical device cases where thousands of patients suffer similar injuries across the United States. At the Blackwell Law Firm, we have represented many injured Alabama consumers in prior MDL proceedings involving other dangerous drugs.
If you or a family member suffer personal injuries from a dangerous drug or defective medical device, look for an attorney experienced with all the following: (1) Federal court cases; (2) Complex medical injuries and evidence; and, (3) Your local physicians. Too often, patients injured by dangerous drugs contact a lawyer who lacks experience in these complex injury cases. Drug companies use lawyers who understand the legal procedures and medical science. You need an attorney who can fight them. Too often, patients injured by dangerous drugs contact a lawyer who mass advertises across the country. These mass advertising lawyers treat you like a number. Yet, you deserve individual attention. You need a lawyer who knows his or her clients personally. You need a lawyer who has worked with physicians and experts in Alabama. We know all our clients personally and study every detail of their cases. We regularly work with local Alabama physicians to prepare our personal injury cases. If you have questions about any Alabama personal injury, let us know. Our consultations are always free and confidential. We are happy to answer your questions.