Eye Damage Now a Possible Elmiron Side Effect
With an estimated 8,000,000 women in the U.S. suffering from Interstitial Cystitis (IC), Elmiron is still the only oral prescription drug approved to treat symptoms (IChelp.org). Until recently, Elmiron side effects have been little concern to the medical community.
The painful bladder syndrome drug, also known by the generic name Pentosan Polysulfate Sodium, has been on the market for 24 years. Yet recent studies have shown an alarming link between Elmiron and a newly discovered side effect; an eye disease known as retinal maculopathy.
What does this mean for thousands of Americans, particularly women?
If you are one of the countless individuals who have used Elmiron, the following is urgent information that concerns your health. Whether you took the medication for a short or extended period of time, every patient — both past and present — is advised to see a trained ophthalmologist as soon as possible and begin documenting their vision health.
The dangerous drug attorneys at Hodes Milman Ikuta are currently accepting claims for anyone who has suffered eye damage after taking Elmiron. If you’re interested in learning about your potential for compensation, please contact our firm today at (949) 640-8222.
The Research Behind Elmiron’s Long Term Side Effects
Elmiron’s makers, Janssen Pharmaceuticals, have recently come under criticism for the IC drug’s link to permanent vision problems. However, what many are unaware of is that Janssen Pharmaceuticals knew about this risk since the late 1990s when a four-year clinical trial revealed optic neuritis and retinal hemorrhage in participants.
Rather than researching these side effects further, Janssen determined they weren’t significant enough to require extended study.
Since then, several studies have raised concerns for patients and the medical community alike.
Emory Eye Center’s Discovery in Atlanta, GA
It wasn’t until 2015, when doctors at Emory Eye Center in Atlanta, GA brought Elmiron’s eye damage risks to light again when it released a report on six of their patients. They noticed the patients — all of whom were women — were diagnosed with the same new eye disease. Even though none of them had any previous conditions to point to their diagnoses, they each had retinal maculopathy.
A deeper analysis of each woman’s medical history gave Emory’s doctors the answer they were looking for: all six patients were taking Elmiron. The youngest of them was just 37 years old, yet she began to take notice of her symptoms when she was 30.
The study was published in 2018, and ophthalmologists across the U.S. began to conduct their own research on Elmiron side effects.
Kaiser’s Study in Oakland, CA
When doctors at a Kaiser hospital in Oakland learned of Emory’s study, they took it upon themselves to find every patient using Elmiron in their database. Their records showed 140 people with Elmiron prescriptions, and 91 of them agreed to be tested for retinal maculopathy.
A startling 25% of those examined showed signs of the new eye disease.
In spite of this second study, which showed even more distressing results than those from Emory’s findings, Elmiron sales continued as usual and Janssen Pharmaceuticals remained quiet on the research.
IC Network Survey, 2019
Yet the most troubling news for Elmiron users came from a survey given by the president and founder of the Interstitial Cystitis Network, Jill Osborne in December of 2019. Osborne invited readers to participate in a survey to help understand how many of them were dealing with eye problems after using Elmiron.
Of those surveyed, 54% reported having eye damage.
The unfortunate reality is that hundreds of thousands of people living with IC and using Elmiron have been unknowingly exposed to eye damage risks. Because Janssen Pharmaceuticals failed to educate medical professionals, patients taking Elmiron, and even themselves about serious eye disease risks, thousands of women may suffer as a result.
Even now, as doctors and patients grow in their awareness, much is yet to be learned about how and what is strengthening the link between Elmiron and retinal maculopathy.
Retinal Damage More Severe Than Other Elmiron Side Effects
With mounting research revealing vision problems in Elmiron patients, how do these numbers compare with the risk and severity of other side effects?
The most common Elmiron side effects according to Janssen Pharmaceuticals are:
- Hair loss
- Weight gain
- Swelling due to fluid buildup
- Abnormal liver function tests
- Blood in stools
Few of these conditions might require immediate medical attention, though most are considered minor. They are also experienced by a relatively low percentage of patients, as an FDA clinical trial showed:
- Alopecia (4%)
- Diarrhea (4%)
- Nausea (4%)
- Headache (3%)
- Rash (3%)
- Dyspepsia (2%)
- Abdominal pain (2%)
- Liver function abnormalities (1%)
- Dizziness (1%)
In contrast to this, the news of Elmiron patients suffering from eye problems is much more serious. Not only are early analyses showing the damage may not be reversible, but the number of patients experiencing retinal damage is far higher than the number of those dealing with all other Elmiron side effects combined.
The number of patients experiencing retinal damage is far higher than the number of those dealing with all other Elmiron side effects combined.
Worse, many women dealing with the new eye disease are learning about it from their doctors rather than from the manufacturer. They are finding out after having used Elmiron for decades in certain cases, rather than having this knowledge before they agree to take the drug as it is supposed to be.
It’s important to note that drug manufacturers have a responsibility to notify patients and doctors of serious side effects associated with their drugs at the earliest known time. Patients have a right to weigh for themselves whether a drug’s benefits are greater than its risks. This is a term in ethics and law known as informed consent.
An example of informed consent is providing the patient with a document that lists all known side effects and risks associated with a drug. The patient is required to “sign off” on this, agreeing that they have been formally presented with the information before they can receive a prescription.
When drug makers fail to do this, they can be held liable. This type of lawsuit is known as a product liability lawsuit, as explained here:
A marketing defect occurs when a manufacturer fails to warn consumers about a product’s hazardous characteristics, or may have the product prescribed ‘off-label’ meaning the drug is used for a reason it was not approved for by the Food and Drug Administration. This type of defect is commonly associated with pharmaceutical medications, commonly referred to as ‘dangerous drugs.’
Little is known about retinal maculopathy since it has only recently been discovered, though it has been compared to another condition known as retinal toxicity. Here is what we know so far.
What Is Retinal Toxicity and How Does It Relate to Retinal Maculopathy?
Retinal toxicity is a term used to describe damage to the retina by toxins, typically from a drug. It is most understood by its symptoms, which include a loss of color vividness, trouble reading, and a blurred spot in the center of a person’s vision often called bull’s eye maculopathy.
Until now, retinal toxicity has mostly been associated with antimalarial medication hydroxychloroquine. However, Elmiron patients have been showing many of the same symptoms.
This drug-induced retinal toxicity is what doctors believe is behind the cause of retinal maculopathy:
“The authors (of Emory’s study) suggest that the retinal cells may be accumulating PPS (pentosan polysulfate sodium or Elmiron) or a toxic metabolite over time.” – Jill Osborne, IC Network
Symptoms of Retinal Maculopathy
Retinal maculopathy is a “novel” disease, meaning it’s a disease never seen before. As doctors search for answers, they are noticing a list of commonly reported symptoms among Elmiron patients, including:
- Trouble reading
- Blurred vision
- Trouble adjusting to dark environments
- Seeing “spots” in the center of eyesight
- Image distortion or a “warped” appearance
- Color dullness
However, retinal maculopathy diagnosis is not as straightforward as it might seem. There are several reasons for this:
1. Retinal maculopathy symptoms are similar to age-related macular degeneration (AMD) and pattern dystrophy.
Age-related Macular Degeneration (AMD) is a term for retinal damage wherein a person loses their central vision. As the primary cause of vision loss in people age 50 and above, other risk factors include obesity, smoking, high blood pressure, and family history (American Academy of Opthalmology)
Pattern dystrophy (PD) is a broad category term referring to several types of retinal diseases that involve a buildup of waste in the macula. Unlike AMD, PD is caused by a gene mutation and is passed on through genetics. Though it has similar symptoms to AMD, it progresses much more slowly (MacularSociety.org).
The similarity in symptoms between AMD, PD, and retinal maculopathy is striking; however, each of their causes differs vastly.
2. Only an ophthalmologist can diagnose retinal maculopathy.
Both AMD and PD can be detected by a typical visit to an optometrist. However, retinal maculopathy requires advanced retinal imaging by an ophthalmologist. This might mean that hundreds, if not thousands of Elmiron patients are being misdiagnosed.
If you have used Elmiron for any period of time and are experiencing eye problems, doctors are urging you to be scanned for retinal maculopathy by a trained ophthalmologist right away.
Eye Damage After Discontinuing Elmiron
In the most recent news surrounding Elmiron’s connection to eye disease, a Harvard University doctor named Rachel Huckfeldt found that one of her patients had worsening vision loss even years after she stopped taking Elmiron.
More than ten years after she stopped taking Elmiron, her vision became worse.
The patient, who she began seeing in 2001, complained of blurry vision and trouble adjusting to dimly lit environments. When after several visits Huckfeldt found no family history or reason for the woman’s failing vision, she concluded that a toxic substance was responsible for the inexplicable eye disease.
She called this condition “toxic retinopathy.”
When Huckfeldt saw Emory’s published findings in May 2018, she immediately confirmed the woman’s medical history. The patient had used Elmiron but had discontinued taking the drug in 2003. Even more than ten years after she stopped taking Elmiron, her vision became worse.
Elmiron Lawsuit Information
As news of Elmiron’s dangers continues to reach more and more patients, we understand you might have questions. We have provided a quick list of answers for anyone who may be thinking about filing a lawsuit.
If you have a question that isn’t answered here, please contact our dangerous drug attorneys at Hodes Milman, LLP completely free of charge at (949) 640-8222. Your call is complimentary and without obligation.
Will it cost me to join the Elmiron lawsuit?
No, there is no upfront cost to filing a lawsuit for your injuries against Janssen Pharmaceuticals. Our Elmiron lawyers will provide you with a free consultation, during which we will assess your unique circumstances without any pressure or obligation to hire us for your legal needs. Our firm works on what is known as a contingency fee basis, which simply means there are no out of pocket fees and no fees unless we win your case. This fee is drawn from any recovery amount you receive.
Other law firms are taking Elmiron cases, how is yours different?
While there are many law firms taking Elmiron cases, not all of these firms have the necessary experience to effectively handle your case.
First, Hodes Milman, LLP is highly skilled and well-versed in the area of pharmaceutical litigation. We have an established reputation as a medical malpractice law firm and are intimately acquainted with the nuances of what it takes to challenge pharmaceutical companies. Much of our strategy is drawn from a keen understanding of healthcare laws and science. Our attorney backgrounds combine to bring you over 30 years of experience, including trial experience. We’ve helped our clients receive $250+ million in verdicts and settlements and have the financial backing necessary to see your case through.
Secondly, large medical conglomerates like Janssen Pharmaceuticals are fully equipped with adept legal teams that relentlessly protect their own interests. It will require robust resources, such as field experts, investigation, and extensive preparation. Hodes Milman, LLP has the means to compete with sophisticated defense teams such as those cushioning big drug companies.
Lastly, we are available, resourceful, and completely committed to you. This is what sets Hodes Milman, LLP apart from other respectable law firms. You will always be a client to us, and even when your case is resolved, our door remains open to you.
How do I know if I qualify?
Since the details surrounding each person’s story will be different, the best way to understand whether you qualify for the Elmiron lawsuit is to call us today and have our experienced attorneys review your potential case.
Speak to Our Elmiron Lawyers Today
Elmiron’s eye disease danger concerns all patients, both past and present. Please be advised that if you’ve stopped taking the drug or do not have symptoms, you might still be at risk for developing retinal maculopathy.
Our dangerous drug attorneys stand ready to help you choose the best option for you and your family. Don’t wait to see if you qualify; contact Hodes Milman Ikuta today.
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