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According to the Elmiron lawsuits recently filed in the US, the potentially dangerous drug originally used to treat bladder discomfort and pain linked to interstitial cystitis (IC) can subsequently cause serious eye damage through long-term or chronic exposure to the drug. Plaintiffs claim the substance manufactured by Janssen Pharmaceuticals is linked with a certain type of retina damage known as pigmentary maculopathy that could lead to ocular damage and even permanent vision loss or blindness.
If you or a loved one developed any eye condition or symptoms associated with an eye disorder after taking Elmiron for interstitial cystitis or osteoarthritis, please fill in our form. We will do our best to ascertain whether your case qualifies to be brought to court, and if you may be entitled to compensation.
Elmiron is a drug known as pentosan polysulfate sodium (PPS), a semi-synthetic medication manufactured by Johnson & Johnson and its subsidiary Janssen Pharmaceuticals from beech-wood hemicellulose. Since its release in 1996, Elmiron is prescribed for interstitial cystitis, a painful bladder condition associated with symptoms such as abdominal cramps and discomfort that are often very hard to treat. Pentosan polysulfate sodium provides relief from bladder pain syndrome by forming a protective coating to the organ’s wall. If the patient suffers from chronic interstitial cystitis, Elmiron must be taken for extended periods of time to provide relief from symptoms.
Pentosan polysulfate sodium has also been tested a disease modifying osteoarthritis drug (DMOAD) to improve pain and function in patients with this disorder. According to some recent studies, the drug ameliorated the symptoms and enhanced the mobility of patients in terms of pain while walking, climbing stairs, flexing knees, etc.
In 2019, three ophthalmologists from Kaiser Permanente in Northern California found convincing evidence of a link between the use of Elmiron in cystitis patients and maculopathy. The researchers presented their finding at the 123rd Annual Meeting of the American Academy of Ophthalmology, and they were not the only doctors who found a link between Elmiron and a number of vision problem along with vision loss. PPS can very well be toxic to the retina according to Dr. Nieraj Jain, MD, from Emory Eye Center in Atlanta, GA, who found that another six patients being treated with Elmiron eventually developed macular degeneration that could not be explained otherwise.
Since PPS is taken to treat a painful bladder syndrome, very few doctors initially believed it could cause serious eye problems such as macular degeneration and even vision loss. However, the apparently safe Elmiron can subtly cause blindness over time. Unfortunately, the potentially dangerous medication is even recommended for long-term use and many patients take it for a longer period of time and are even often forced to take increasing doses of this drug to keep up with their symptoms.
Other vision issues named in Elmiron lawsuits include retinal pigmentary change or pigmentary maculopathy, blurred vision, macular degeneration, problems adjusting to darkness, eye pain, and even permanent eye damage or vision loss.
The manufacturer updated the Elmiron label in June 2020. Specifically, Janssen added a warning that a type of retinal damage called pigmentary maculopathy had been identified with use of the drug. Elmiron came on the market in 1996 without warnings.
Even with the addition of warning for “retinal pigmentary change,” the manufacturer still has not indicated that it acknowledges claims of eye damage related to Elmiron, or that it will issue a recall because of these increasing cases of eye condition.
At least 120 Elmiron lawsuits have been filed against the producer Janssen. All of the federal cases are consolidated into the District of New Jersey in December 2020. More cases are expected.
If you or a loved one are under treatment with Elmiron for interstitial cystitis or osteoarthritis, you might develop a dangerous maculopathy. Although this means that you may be entitled to financial compensation if your lawsuit is successful, we care about your safety above all else. It is important that you speak with your doctor immediately if you experience any of these symptoms. They might be suggestive of ongoing vision damage or retinal maculopathy:
These symptoms may, however, get confused by doctors with signs of other vision impairment such as pattern dystrophy or age related macular degeneration.
It is also important to note that before you make any decision about your treatment, you should seek your physician’s advice first and foremost. If you stop taking this bladder drug, in fact, its positive effects will gradually wear off and the pain for which you originally took Elmiron will slowly reappear.
On May 4, 2020, plaintiff Tina Pisco filed the first Elmiron lawsuit claiming she developed maculopathy after being prescribed the drug for her interstitial cystitis. The woman received her diagnosis of cystitis in 2012, and started taking Elmiron to treat it for several years. In March 2019, Pisco started suffering from a number of vision damage symptoms, which were apparently unrelated with the original disease. Eventually, because of chronic exposure to Elmiron, she was diagnosed with a pigmentary maculopathy in both eyes, a much more serious eye disease that leads to permanent retinal injury.
According to her claim, the long term use of Elmiron was the reason of her vision loss, but the manufacturer never warned her or the other Elmiron patients of side effects which could lead to a number of eye injury and even a serious retinal disease. In fact, Janssen Pharmaceuticals kept claiming that PPS was completely safe. If the woman’s lawsuit will be successful, she may be entitled to a large monetary compensation, and many other Elmiron litigation will likely follow.
According to Elmiron’s original label, the cystitis drug is associated with just a handful of minor side effects. In particular, those listed by the manufacturer’s official website are:
Note that maculopathy is not included among them. Some vision problems are included among the uncommon side effects, but the particularly serious eye disease is not listed among them. In particular, Elmiron may cause:
In Canada, the national regulatory agency required the pharmaceutical company to update its warnings last year. They requested the inclusion of a specific indication about reported cases of the eye disease known as pigmentary maculopathy associated with the use of pentosan polysulfate. Patients who are long-term Elmiron users are also required to have regular ophthalmic examinations for early detection of possible vision issues due to Elmiron toxicity.
In the United States, the prescribing information that accompanies Elmiron does not include these details. On the contrary, it laconically states “Warnings: None.” Therefore, not one Elmiron patient has ever been adequately warned of the risks of eye injury and other potentially permanent eye damage. Because of this, the recently filed lawsuit claims that the pharmaceutical company released a potentially dangerous drug without ensuring its safety with proper tests. The company has been accused of negligence and, more importantly, of voluntarily withholding critical material about side effects and adverse events associated with taking Elmiron which could lead to pigmentary maculopathy along with a number of other serious eye condition and even blindness.
A common question that we are often asked is whether it is really worth to invest your time and money to file a civil action against those who allegedly harmed you. Being scared by the idea of facing a court is completely understandable, especially if you’re not sure of your winning chances. However, that’s exactly why we’re here: to answer all your questions and dispel any doubts you have.
During our initial consultation, we will properly evaluate your case to determine if your chances of winning are high enough to file a case. We understand how hard and challenging it could be to fight with a disease or injury, and having to face the stress of a trial. That’s why we will do our best to take all necessary steps and help you find the best Elmiron attorney to maximize your chances of winning and minimize the pressure you’re going to face. Needless to say, the initial consultation is completely free and without any obligation.
To put it shortly: Nothing unless you win. We will put you in contact with lawyers that are only paid on a contingency basis. This means that unless you successfully reach a settlement and your case is victorious, you do not owe anything to the law firm that will handle your Elmiron litigation – not even trial expenses. The fee you will be charged in case of victory is standardized as well, and is set by the corresponding national bar.
Nobody wants to face a disease or be harmed. We all want to live healthy and serene lives, but no matter how careful we are, bad things happen sometimes. In the United States, dealing with a physical issue requires money, even more so if it’s a serious eye condition or a long term, impairing disability such as a retinopathy or maculopathy. If your case is successful, however, you may be entitled to sufficient money to pay your medical debts. In some instances, filing an Elmiron lawsuit can very well be the only way to ensure you have the necessary money to deal with the medical bills and mounting expenses from the vision damage you have suffered.
But that’s not all. A patient filing an Elmiron case means seeking justice against those who harmed them or a loved one by causing them to suffer from Elmiron vision problems. From a broader perspective, it is the responsibility of a patient, most importantly as an American citizen, to do all they can to stop those who willfully harm others for their own profits. Many pharmaceutical companies such as Janssen Pharmaceuticals are negligent and unscrupulous in releasing to the market unsafe or poorly tested drugs and medical devices. Pinning them to a wall with the instruments provided to us by the law is a civil responsibility that we all share to prevent them from causing more damage to other patients in the future.
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