The connection between Elmiron and pigmentary maculopathy was made in 2018 and presented at the meeting of the American Academy of Opthalmology in 2019. The research presented demonstrated a link between the drug Elmiron and pigmentary maculopathy, a unique type of ocular damage that can result in permanent vision loss and even blindness.
Patients who have taken Elmiron long-term run the greatest risk for developing ocular damage as a result. Because pigmentary maculopathy is unique, it has been misdiagnosed by medical professionals as another type of eye disorder such as macular degeneration. However, additional testing showed for these patients that their ocular damage was actually caused by their long-term use of Elmiron to treat interstitial cystitis.
Some of these patients are considering filing a lawsuit against the division of Johnson & Johnson that manufactures Elmiron, Janssen Pharmaceuticals and Teva Branded Pharmaceuticals, another manufacturer of Elmiron.
Should I Consider an Elmiron Lawsuit?
If you have taken Elmiron for six months or longer in order to treat interstitial cystitis and experienced ocular damage due to pigmentary maculopathy as a result, you may have a case against the companies that manufactured Elmiron. It’s a good idea to consult with an attorney experienced in drug injury lawsuits to determine if you could be eligible for compensation. Drug injury lawsuits have resulted in compensation for lost wages and medical costs, among other things, for the plaintiff.
What Lawsuits Have Been Filed Against Johnson & Johnson?
In March of 2020, a lawsuit against Teva Branded Pharmaceuticals and Johnson & Johnson was filed in Connecticut. Both companies have marketed and manufactured Elmiron since the 1990s. The plaintiff of the lawsuit claims that she has suffered from pigmentary maculopathy as a result of having taken Elmiron for the long-term treatment of interstitial cystitis. The lawsuit alleges that this occurred due to the companies’ failure to warn patients of the risks of eye damage or the need to have regular eye exams to screen for pigmentary maculopathy.
Since then, many additional lawsuits were filed against Johnson & Johnson. The cases were consolidated into a multi-district litigation (MDL) in December 2020 and by December of 2021, there were 672 individual lawsuits included in the MDL. It’s expected that more will lawsuits will follow to bring the total into the thousands for the MDL. Lawyers for plaintiffs are asking for $10 million from the company.
Have There Been Any Settlements from Elmiron Lawsuits?
The lawsuits against Janssen Pharmaceuticals and Teva Branded Pharmaceuticals have not yet been settled and are still in progress. If the ongoing lawsuits against the manufacturers of Elmiron are successful, the plaintiffs will most likely receive compensation for pain and suffering, medical expenses, lost wages, and more.
Although the MDL lawsuits were filed in 2020 and 2021, the cases have not yet been settled. The COVID-19 pandemic has affected many cases by delaying them. Therefore, many cases that have been filed may have settlements delayed.
Are There Any Elmiron Class Action Lawsuits?
Of the patients who have taken Elmiron for six months or longer, up to 25% of them may develop pigmentary maculopathy. The lawsuits currently ongoing against the manufacturers of Elmiron are not class action, but the companies could be facing more legal action in the future. A class-action lawsuit could benefit both the plaintiffs and those who suffered from pigmentary maculopathy but aren’t involved in legal action as well.
Has Elmiron Been Recalled?
Despite the research linking Elmiron to pigmentary maculopathy in appearing as early as 2018, Elmiron is still on the market as of 2020. The manufacturers of Elmiron have not added any warnings about the dangers of ocular damage, nor have they issued a recall of the drug. The manufacturers are also not warning patients about the need for regular eye exams to catch any eye damage early. In addition, the FDA has not issued a recall of the drug or ordered a warning label be added.
Patients taking Elmiron to treat interstitial cystitis may continue taking the drug long-term without even knowing the risks the drug poses to their eyesight or knowing that they should be getting their eyes checked to screen for eye damage.
What Warnings Has the FDA Issued for Elmiron?
Though the connection between macular damage and Elmiron was identified in 2018 and studied the following year, no warnings have been added to prescribing information for Elmiron. Current labelling does not include any warnings for visual disturbance, macular damage, night blindness or any other eye conditions associated with pigmentary maculopathy.
What is Pigmentary Maculopathy?
Pigmentary maculopathy is a type of ocular disorder that affects the macula of the eye. The macula is the part of the eye that most clearly sees vision. Any eye disorder that has maculopathy in its name is one that affects the macula. Pigmentary maculopathy in particular is a unique type of maculopathy that is caused specifically by Elmiron toxicity. This type of maculopathy is named for the changes that occur in the pigmentation of the eye in patients that develop the condition.
What Are the Links Between Elmiron and Pigmentary Maculopathy?
Elmiron was linked to pigmentary maculopathy in 2018 by a team of opthalmologists who noticed a trend of eye damage in patients taking Elmiron long-term for treating interstitial cystitis. These researchers conducted a study in Northern California at Kaiser Permanente, reviewing patients taking Elmiron. It was through this patient review that they discovered that up to 25% of interstitial cystitis patients taking Elmiron for six months of longer developed pigmentary maculopathy.
These findings were presented in 2019 to the American Academy of Opthalmology. The research presented showed that, of 140 patients who had taken 5,000 doses, on average, of Elmiron over a period of 15 years, they obtained further examinations of 91 and found that 22, or around 25%, of those patients had developed pigmentary maculopathy. This showed that the longer a patient took Elmiron, the higher the risk of developing pigmentary maculopathy.
Due to their findings of the risk of developing pigmentary maculopathy with the long-term usage of Elmiron, ophthalmologists have recommended that anyone taking Elmiron for six months or longer should have annual eye exams. Stopping taking Elmiron if eye damage is discovered could prevent any further damage from occurring. It’s essential to catch pigmentary maculopathy early because if it’s discovered too late, vision loss could be inevitable.
How Many People Suffer from Pigmentary Maculopathy?
Thousands of people across the country take Elmiron long-term to treat interstitial cystitis. It’s estimated that of those, 25% could suffer from pigmentary maculopathy. However, pigmentary maculopathy is often misdiagnosed as another type of eye disorder. Most patients taking Elmiron long-term are older, so it’s often thought that the ocular damge is age-related macular degeneration or pattern dystrophy instead.
However, further testing can show that the true type of eye damage is pigmentary maculopathy. Anyone taking Elmiron who has been diagnosed with eye damage that is not pigmentary maculopathy should seek testing to determine whether their ocular condition is in fact Elmiron-related.
What Are the Symptoms of Pigmentary Maculopathy?
The symptoms of pigmentary maculopathy can include:
- Night blindness
- Loss of close vision
- Blurry vision
- Visual dimming
- Seeing dark spots
- Difficulty reading
What sets pigmentary maculopathy apart from other types of maculopathy is the hyperpigmentation that occurs on the macula of the eye. These darker spots on the macula are how opthalmologists can determine that the ocular disorder is pigmentary maculopathy rather than another type of eye disorder.
What is Elmiron?
Elmiron was developed by Teva Branded Pharmaceuticals before the company licensed the drug to Janssen Pharmaceuticals, a division of Johnson & Johnson, who submitted an application for the drug to the FDA in 1985. Elmiron is the brand name of pentosan polysulfate sodium and was, when it was approved, one of the only treatments available for interstitial cystitis, or IC.
Elmiron is a heparin-like compound with fibrinolytic and anticoagulant properties that has a low molecular weight. It’s unknown exactly how Elmiron works to treat interstitial cystitis, but patients with the condition who are prescribed Elmiron take the drug in 100mg doses three times a day on an empty stomach.
What is an Orphan Drug?
The FDA approved Elmiron and classified it as an “orphan drug,” which is a drug that is the only medication or one of only a few medications that can treat a certain rare condition, in this case interstitial cystitis. Because of the relative rarity of the condition an orphan drug is designed to treat, there are often financial incentives from the government for companies to develop these drugs on top of profits made selling the drug to patients. Interstitial cystitis was thought to be a rare condition when Elmiron was approved. However, further research since then has shown that it affects up to a million people across the US.
What Does Elmiron Treat?
Elmiron is used to treat interstitial cystitis, a bladder condition also known as painful bladder syndrome. It can take up to three months of taking Elmiron to determine whether or not it is successful at treating interstitial cystitis for a particular patient. If it’s not successful, the patient’s doctor would typically stop prescribing it after six months. Patients for whom the drug successful treats IC may end up taking the drug for long periods of time, if not perpetually.
For patients that have seen success with Elmiron in treating interstitial cystitis who then take the drug long-term to treat the condition, there’s an increased risk of developing eye damage in the form of pigmentary maculopathy. The longer a patient takes Elmiron, the greater the risk of developing the condition as a result of Elmiron toxicity.
What is Interstitial Cystitis?
Interstitial cystitis, or IC, is also known as painful bladder syndrome. IC is characterized by the frequent urge to urinate as well as pain in the pelvic region. Sufferers of IC feel the need to urinate as frequently as 40-60 times daily. Most of those affected by the condition are women, but it can affect men as well.
The symptoms of IC can start out slowly but then gradually worsen over the following months. Symptoms can also change on a daily basis and can be either triggered or worsened by other conditions such as endometriosis or irritable bowel syndrome.
Interstitial cystitis can be excruciatingly painful. This can make it difficult for patients suffering from the condition to work full-time.
Who is Most at Risk of Developing Interstitial Cystitis?
Interstitial cystitis is far more common in women than in men, although members of both genders can develop the condition. In men, the symptoms of interstitial cystitis often turn out to be an inflamed prostate instead of IC. Most people who do develop IC are older, with the youngest generally in their 30s. It’s also more common in people with fair skin and red hair.
The risk factors that increase the likelihood of developing IC are:
- Having a pre-existing chronic pain condition
- Having fair skin and red hair
It’s unknown exactly what causes interstitial cystitis, but it’s often associated with other conditions, including:
- Migraine headaches
- Irritable bowel syndrome
- Chronic fatigue syndrome
What Are the Symptoms of Interstitial Cystitis?
The symptoms of interstitial cystitis can include:
- A frequent and persistent urge to urinate
- Frequent urination, typically in small amounts, up to 60 times a day
- Pain in the anus and the vagina (in women) or scrotum (in men)
- Chronic pain in the pelvis
- Pain during sexual intercourse
- Pain as the bladder fills that is only relieved by urinating
The symptoms can vary in both severity and which symptoms are most common. Some IC sufferers may have symptom-free periods in-between episodes of symptoms. Others experience symptoms constantly.
The symptoms of IC can be similar to those of OAB, or overactive bladder syndrome, which can also cause a frequent and urgent need to urinate. However, IC is different from OAB in that it can actually cause changes to the cells in the tissue of the urothelium, which is the layer of tissue surrounding the bladder.
The symptoms of interstitial cystitis can also mirror those of a urinary tract infection, although there won’t actually be any infection. If someone with IC does develop a urinary tract infection on top of interstitial cystitis, the symptoms of IC will likely grow worse in severity.
What Complications Can Arise from Interstitial Cystitis?
Interstitial cystitis is a chronic condition that can be treated, often with Elmiron. In addition to the risk of pigmentary maculopathy, there are other complications that can arise from the condition itself:
- Smaller bladder capacity
- Lack of intimacy
- Emotional stress
- Interrupted sleep
- Poor quality of life
Many people who suffer from IC have difficulty maintaining a normal quality of life. Social activities are frequently interrupted by the need to urinate, making it difficult to maintain relationships. Pain during sex can lead to a lack of intimacy, making romatic relationships difficult as well.
While it’s important to treat interstitial cystitis in order to prevent both symptoms of IC and the complications that can arise from it, Elmiron is no longer the only drug on the market for treating the condition. In the time since Elmiron was approved by the FDA and classified as an orphan drug, the medical community’s understanding of interstitial cystitis has improved dramatically. There are also other treatment options for the condition that don’t run the risk of Elmiron toxicity and the pigmentary maculopathy that can result from long-term usage of Elmiron.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.