For the first time since Elmiron® came on the market in 1996, the prescription bladder medication will come with warnings about the risk of vision damage.
The significant changes to the label reflect the mounting concern of researchers who have found Elmiron linked to vision problems, and the growing number of patients who are coming forward saying they have been injured by the drug.
Elmiron (pentosan polysulfate sodium) is a medication prescribed for the treatment of interstitial cystitis (IC). It is the only drug approved by the U.S. Food and Drug Administration (FDA) to treat IC. For years, Elmiron was thought to be a fairly safe drug with few dangerous side effects.
Now, Elmiron sold in the United States will come with a new warning about the potential risk of permanent eye damage.
It’s important that people who currently use Elmiron — or have used it in the past for an extended period of time — understand these new risks.
New Elmiron Warnings and Recommendations
The FDA approved changes to Elmiron’s label include additional warnings for patients, as well as new guidance for physicians.
Elmiron May Cause Damage to Retina
The new warning section begins, “Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON®.”
What this means: Current research suggests that Elmiron may be toxic to the retina, which is the light-sensitive inner lining at the back of the eyeball. The drug is suspected to cause abnormalities in the pigmented layer of tissue in the macula, located at the center of the retina.
This emerging, unique type of eye disease, called pigmentary maculopathy, has been detected in several studies of people who have used Elmiron.
Some of the symptoms from the reported cases were distorted vision, problems with reading, and having to wait longer for their vision to adapt to a dark setting.
The label informs patients that:
- Most cases occurred after 3 years of use or longer
- Some cases have occurred with shorter duration of use
- The total amount of the drug a person has had over time (cumulative dose) appears to be a risk factor
Changes in retinal pigment can be caused by other factors, and the label says “Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment.”
Along with the updated warning about retinal pigmentary changes, the label includes recommendations for Elmiron users and those considering taking the drug.
Elmiron Users Should Report Changes in Vision
The Patient Information section of the label has been updated to inform Elmiron users that they should report changes in vision to their physician and have them evaluated.
Although the changes caused by Elmiron are not fully understood, some of the common visual symptoms reported include:
- Blurred vision
- Difficulty reading
- Slow adjustment to low or reduced light environments
At-Risk Populations Should Get Exam Before Using Elmiron
Prior to treatment, it’s recommended that patients obtain a detailed history of their eye health. This is because genetics and pre-existing eye conditions may cause similar pigmentary changes in a person’s retina.
Those with a family history of hereditary pattern dystrophy are advised to consider genetic testing before beginning therapy. Those who have pre-existing eye conditions should have a retinal exam first.
The recommended tests include:
- Auto-fluorescence imaging
- Color fundoscopic photography
- Ocular coherence tomography (OCT)
Understanding a person’s baseline retinal health is important for making a safe decision about whether or not to use Elmiron, and accurately determining its effects once therapy begins.
All Elmiron Users Should Have Routine Exams
After starting treatment, it's recommended that all patients receive a retinal examination within 6 months to determine whether or not pigmentary changes in the retina develop.
Patients should return for similar exams periodically during treatment, reevaluating the treatment if changes appear. The change or loss in vision may be irreversible. Since retinal and vision changes can progress even after treatment has ended, follow-up visits are encouraged.
Risks to Patients Shouldn’t Be Hidden
Patients have a right to know all of the risks associated with the drugs they take. Unfortunately, many prescription medications enter the market long before the extent of the danger is fully understood.
Last year, the FDA issued a safety communication that required a boxed health warning on the labels of Xeljanz® and Xeljanz XR®, two drugs made by Pfizer to treat arthritis and ulcerative colitis.
After reviewing the drugs postmarket performance, the FDA determined that people taking these medications twice daily could be at increased risk of blood clots or death.
Until the FDA approved the new warning, people taking either type of Xeljanz were unknowingly putting themselves in danger, especially if they had a medical history of heart problems or blood clots.
Sometimes, drugmakers will actively hide risks from consumers or present information in a misleading way to make a dangerous product appear safe. Perhaps the most notorious case of downplaying risks on drug labeling is OxyContin®, the prescription opioid manufactured by Purdue Pharma that kickstarted the opioid epidemic.
When Purdue launched OxyContin, they did everything they could to downplay the addictive potential of their powerful narcotic painkiller.
The original label said that addiction was “very rare” if opioids were used for pain management. There was no significant evidence to back this claim, which has been proven false by the ongoing public health tragedy associated with opioid addiction.
In 2018, overdoses involving opioids killed nearly 47,000 people, according to the U.S. Centers for Disease Control and Prevention (CDC). Approximately 32% of those deaths involved prescription opioids.
Purdue has since filed for bankruptcy and recently spent $24 Million on an ad campaign to help people who had been injured file opioid lawsuits. To this day, the company has denied any wrongdoing, despite the fact that its deception has been exposed.
Elmiron, Jannsen, Johnson & Johnson and the Dangers of Deceptive Marketing
The company that manufactures Elmiron, Jannsen Pharmaceuticals, is a subsidiary of Johnson & Johnson. Like Purdue Pharma, both Jannsen and Johnson & Johnson have been implicated for their role in igniting the opioid epidemic.
In August 2019, Johnson & Johnson was ordered to pay the State of Oklahoma $572 Million over allegations regarding its deceptive marketing practices of opioids. Despite the high figure, it was a small amount compared to the billions of dollars state prosecutors had asked for.
Unsurprisingly, Johnson & Johnson has disputed the ruling, saying that the company has always been upfront and honest with consumers about the risks posed by their products.
Nothing could be further from the truth. Consider Johnson’s® Baby Powder, one of the most recognizable products on the American market.
For years, the company privately worried about asbestos contamination in their talc mines. Talc is the key ingredient in baby powder, and Johnson & Johnson knew that if it was tainted by asbestos, the product could cause mesothelioma, ovarian cancer, and other deadly asbestos-related diseases.
An investigation of internal memos by Reuters revealed that Johnson & Johnson had detected asbestos in its talc mines several times without ever alerting regulators or the public. Even when confronted by the evidence, Johnson & Johnson said they had done nothing wrong. There was never any warning about asbestos on the bottles of Johnson's baby powder.
In response to the Reuters investigation, the FDA stepped up their testing of talc products, and in 2019, the agency announced that they had detected asbestos in a bottle of Johnson’s Baby Powder. The company disputed the findings, but earlier this year, they took the unprecedented step of removing all talc-based baby powder from the North American market.
Currently, Johnson & Johnson faces some 18,000 talcum powder lawsuits filed by people who claim the company’s products caused their cancer.
Elmiron Lawsuits Help Victims and Force Corporate Transparency
Elmiron was not the first drug to enter the market without a warning label that adequately protected consumers.
And it will not be the last.
One of the most powerful ways to promote safer behavior on the part of drug manufacturers is to file a dangerous drug lawsuit. For more than 40 years, Sokolove Law has represented individuals hurt and killed by dangerous drugs. We help clients build a strong case and stand tall against the powerful corporations that injured them.
If you or a loved one has taken Elmiron and experienced any negative changes in vision, contact us today for a free legal case review.
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