Recent research has linked Elmiron, the only FDA-approved medication to treat a bladder condition called interstitial cystitis, to potentially serious vision problems.
Interstitial cystitis is commonly known as painful bladder syndrome. Patients experience painful and frequent trips to the bathroom, sometimes up to 60 times a day. The disorder predominantly affects women. Common symptoms include stomach, back and pelvis pain, a constant need to urinate, pressure on the bladder and a burning sensation while urinating. It’s estimated that more than 1 million Americans are afflicted with interstitial cystitis, which has no cure.
Elmiron works by coating the inside of the bladder and protecting it from irritants, which reduces many of the symptoms associated with interstitial cystitis. But Elmiron users should be concerned about their risks of developing a condition called pigmentary maculopathy.
How Taking Elmiron Can Affect Your Vision
In 2020, the FDA added a warning to Elmiron’s label stating it may impact the retina, leading to potential vision loss. Many taking Elmiron have experienced blurred vision, difficulty reading, and trouble adjusting to dark and well-lit environments. Studies show that pentosan polysulfate sodium, Elmiron’s active ingredient, may change the pigmentation of the retina – leading to pigmentary maculopathy. Researchers believe the condition could lead to permanent vision loss if left unmonitored and untreated.
Elmiron users should have a baseline retinal exam within six months of beginning the medication. This should include autofluorescence imaging, ocular coherence tomography, and a color fundoscopic photograph scan – all of which involve taking close-up images of the eye to check for abnormalities. Regular follow-ups should be conducted during long-term use.
Pigmentary maculopathy has only been found in long-term Elmiron users. In one study conducted in California, ophthalmologists found that 25% of patients with significant exposure to Elmiron showed signs of damage to the eye. Other retinal disorders like pattern dystrophy or atypical macular degeneration may also be attributed to Elmiron exposure.
The retina is the thin, light-sensing tissue at the rear of the eye. It is responsible for light and color detection and aids in other light-sensitive activities. Retinal damage often goes unnoticed because, without specialized medical training and the ability to evaluate the rear of the eye, the retina is nearly impossible to view. In degenerative eye disorders like pigmentary maculopathy, pattern dystrophy or atypical macular degeneration, the thin layer of tissue is damaged. There is no treatment to restore the retina. Vision loss from retinal damage may be irreversible.
Elmiron Lawsuits Filed Due to Vision Issues
In the four years since Elmiron was first connected to pigmentary maculopathy, hundreds of people have filed lawsuits against Elmiron’s manufacturer, a Johnson & Johnson subsidiary called Janssen Pharmaceuticals. Plaintiffs in these cases allege that Janssen failed to warn doctors and patients of the potential risks. The warning label added in 2020 came nearly 25 years after Elmiron was first prescribed for interstitial cystitis.
Elmiron patients who developed pigmentary maculopathy say the company knew its drug was defective and hid this information from federal regulators, patients and doctors. Plaintiffs claim they were only made aware of mild side effects – such as stomach pain, hair loss, headache and nausea – not potentially life-altering side effects like vision loss. Many have said they would have stopped taking Elmiron had they known its potential for pigmentary maculopathy.
In 2020, the existing lawsuits were combined into multidistrict litigation (MDL) under the same federal court to ease the burden on the legal system. Legal experts anticipate more cases will be filed as more knowledge is revealed about the link between Elmiron and pigmentary maculopathy. The first cases are expected to go to trial in 2023.
If you or a loved one is taking Elmiron, it’s important to seek medical attention should symptoms of vision loss begin. If you decide to take legal action, you must prove that you experienced injury from Elmiron with an official diagnosis by an ophthalmologist.
You should also contact a personal injury attorney experienced in dangerous drug lawsuits. They can help you win compensation for medical expenses, lost wages, economic disability, bodily injury, pain and suffering, and more.
When you are prescribed medication for a health condition, it’s crucial to learn and ask your doctor and pharmacist questions. As a patient, consider all the side effects, whether mild or severe. Taking a prescribed drug to treat a health problem should not place you or your loved ones at risk of developing additional health problems.