Elmiron is prescribed to treat the condition interstitial cystitis, or Painful Bladder Syndrome. It isn’t known exactly how the medication helps ease the symptoms of interstitial cystitis. Elmiron has been linked to eye damage in patients who have taken the drug for a long period of time. Despite studies that have linked Elmiron to eye damage in patients taking it long-term, the FDA has not issued any recalls for the drug.
Many mistake the eye damage caused by Elmiron as due to age or another cause, but ophthalmologists have linked the eye damage to long-term usage of Elmiron. If you are taking Elmiron and are experiencing changes to your vision, consult a doctor. You may need to stop taking Elmiron right away to prevent further damage. Even though Elmiron has been linked to pigmentary maculopathy, no recalls have been issued and the FDA has not even provided a warning to consumers.
If you or a loved one has interstitial cystitis, has taken Elmiron long-term to treat it, and has experienced eye damage, especially pigmentary maculopathy, you may have a case. Farah & Farah’s attorneys are experienced in fighting pharmaceutical companies that have put profits over people. Let us help you get the compensation and justice you deserve. Don’t wait to contact us.
What Is Elmiron?
Elmiron is the brand name of pentosan polysulfate sodium. There is no generic version of the medication available in the United States and a prescription is required to take it. Elmiron is a semi-synthetic, or partly man-made, drug that is similar to heparin, which is an anticoagulant, or blood-thinner.
What Does Elmiron Treat?
Elmiron is used to treat interstitial cystitis. Interstitial cystitis is also called painful bladder syndrome. It’s not known exactly how Elmiron relieves the symptoms of interstitial cystitis. Some scientists believe that Elmiron coats the bladder’s lining and prevents any substances in the urine that could irritate the lining from reaching the cells there.
What Is Painful Bladder Syndrome?
In a normal bladder, the bladder sends a signal to the brain when it’s full. This is what causes the urge to urinate. When someone has interstitial cystitis, the bladder’s signals to the brain get mixed up. They’re sent more frequently and at a much lower volume of urine than normal. The syndrome is painful, typically in the pelvic region of the body.
It’s most common in women but can affect men as well. There is no cure for it, but some therapies and medication like Elmiron can help ease the symptoms.
Causes of Painful Bladder Syndrome
What causes interstitial cystitis isn’t known. It’s most likely that there is no one single cause of the syndrome and that instead, multiple factors contribute to someone developing it. One possible cause is a defect in the epithelium, or the lining of the bladder. If there is a leak in this protective lining, then the toxic substances that are found in urine could irritate the cells on the wall of the bladder.
Other factors that could contribute to Painful Bladder Syndrome include:
- Autoimmune reactions
- Toxins in urine damaging the bladder
- Nerve problems
These factors aren’t proven to contribute to the development of interstitial cystitis, however.
Risk Factors for Painful Bladder Syndrome
Even though the exact cause of interstitial cystitis is unknown, there are certain factors that can increase your risk of developing the syndrome.
- Gender: Even though men can have interstitial cystitis, up to 90% of the people who have it are female. In fact, the same symptoms that indicate interstitial cystitis in women may indicate prostatitis or inflamed prostate.
- Age: Typically, most patients who are diagnosed with interstitial cystitis are in their 40s or older. It’s possible to get it in your 30s, but generally, people younger than that don’t get it. The risk also goes up as you get older.
- Chronic pain: If you already have a chronic pain disorder of some kind, that can increase your risk of also developing interstitial cystitis.
- Skin color and hair color: People with fairer skin and lighter hair colors are at a higher risk of interstitial cystitis than those with darker skin and darker hair.
Between 3% and 6% of women in the United States have interstitial cystitis and 1.3% of American men. That’s a total of up to 8 million American women with the syndrome.
Complications of Painful Bladder Syndrome
Interstitial cystitis, or Painful Bladder Syndrome, can in turn cause some complications. These include both physical and lifestyle complications. Over time, interstitial cystitis can cause the bladder’s wall to stiffen, which reduces its capacity to hold urine. It can also lead to a lower quality of life. With more frequent trips to the bathroom and the pain that comes with the condition, it can interfere with daily activities, social interactions, and even work.
On top of that, interstitial cystitis can cause problems with sexual intimacy, which can put a strain on personal relationships and intimacy with a partner. The syndrome can also lead to interrupted sleep, which can have an effect on both health and quality of life. The lower quality of life, interrupted sleep, and chronic pain can contribute to emotional stress and even depression.
About 5% to 10% of people with interstitial cystitis can also get bladder ulcers.
Symptoms of Painful Bladder Syndrome
The symptoms of interstitial cystitis vary from person to person. The symptoms may also vary over time as well as vary in severity. The most common symptoms of interstitial cystitis are:
- Pain in the pelvis
- Pain between the vagina and anus (in women)
- Pain in the scrotum, testicles, or penis (in men)
- Chronic pain in the pelvis
- Pain during sex
- A persistent need to urgently urinate
- Urinating small amounts often (up to 60 times throughout the day and night)
- Pain as urine fills the bladder with relief after urination
The symptoms aren’t necessarily chronic. Some people have periods with no symptoms at all, followed by periods of experiencing symptoms. The severity will also differ from person to person. The pain can vary from a dull ache to a more piercing pain. It can also hurt to pee, which can vary in severity from stinging to a burning sensation.
Some of the symptoms are similar to those in a urinary tract infection. Typically, there isn’t an infection, however. If someone who does have interstitial cystitis develops a urinary tract infection as well, the symptoms can increase in severity.
Triggers of Painful Bladder Syndrome Symptoms
There are some triggers that can actually make the symptoms of interstitial cystitis worse. These include:
- In women, having a period
- Mental or emotional stress
- Physical stress
- Certain foods:
- Soda pop
- Spicy foods
- High-acid foods
- Artificial sweeteners
What can trigger symptoms or make them worse can vary from person to person. People with interstitial cystitis may want to consult a nutritionist or a dietitian in order to make an eating plan that avoids foods that trigger symptoms. First, however, you should keep track of what foods you ate right before experiencing painful symptoms.
How Is Painful Bladder Syndrome Diagnosed?
There isn’t actually a test that definitively proves that someone has interstitial cystitis. Diagnosis instead typically involves ruling out other conditions that have the same symptoms first. Doctors want to rule out the following conditions:
- Urinary tract infections
- Bladder cancer
- Kidney stones
- Endometriosis (in women)
- Inflamed prostate (in men)
- Chronic pelvic pain syndrome (in men)
Once your doctor has ruled out other possibilities that have similar symptoms, there may be a diagnosis of interstitial cystitis. It’s important to rule out the other possible conditions that can cause those symptoms because some of them are temporary and more easily treatable while others, like cancer, need to be caught early to have the best chance of beating it.
Treatments for Painful Bladder Syndrome
Treatment for interstitial cystitis is mostly about managing the symptoms rather than treating the condition. For many people, interstitial cystitis goes away on its own. Others make lifestyle changes to avoid triggers and to manage the symptoms. The first stage of treatment is typically avoiding foods that trigger symptoms, managing stress, trying to retrain your bladder to go for longer before urinating or some light exercise such as walking. It can take several weeks or even months for the symptoms to stop, however, if these changes work.
The second stage of treatment may be necessary if lifestyle changes haven’t worked. This stage includes physical therapy to relax the pelvic muscles and medication. Elmiron is the only prescription medication that is approved in the United States for treating interstitial cystitis. Over the decades since it was first approved, hundreds of thousands of patients have taken it to treat the symptoms of Painful Bladder Syndrome.
Even though for some patients with interstitial cystitis, the symptoms do ease after a few months, for many, the condition is chronic and they take Elmiron for years.
Side-Effects of Taking Elmiron
Just like with any medication, taking Elmiron is not without its risks and side-effects. Some common side effects of taking the drug can include:
- Hair loss
- Stomach or abdominal pain
- Upset stomach
- Skin rash
If any of these side-effects is persistent or gets worse over time, you should see a doctor. More serious side-effects that warrant immediately contacting your doctor include:
- Discomfort during swallowing
- Changes in mood or mental state
- Unusual bruising
- Unusual bleeding (ex. Bloody stools)
- Fast heartbeat
- Persistent sore throat
- Shortness of breath
- Dark urine
- Yellowing eyes and/or skin
- Vomiting and/or nausea
- Eye pain
- Changes in vision
Symptoms of an Allergic Reaction to Elmiron
Allergic reactions to Elmiron are rare but can be serious. The symptoms of an allergic reaction include:
- Difficulty breathing
- Severe dizziness
If you experience any of these symptoms, contact your doctor immediately. The rash, itching, and swelling are particularly a cause for concern if they appear in the throat, tongue, and face.
Elmiron Linked to Eye Damage
Elmiron has been linked to eye damage, particularly to the retinas. Ophthalmologists at Kaiser Permanente in California did a study on 140 patients who had taken Elmiron over the course of fifteen years. That study found that in about a quarter of patients who have taken large amounts of Elmiron had experienced damage to their retinas. Often, this damage was mistaken for pattern dystrophy or the age-related macular degeneration rather than maculopathy caused by Elmiron toxicity.
The study didn’t determine exactly how much Elmiron was too much Elmiron. The author of the study, Dr. Robin Vora, said that patients who don’t yet show signs of Elmiron toxicity should still be screen at least once yearly. This is to catch eye damage early so that further damage can be prevented by stopping taking Elmiron.
What Is Pigmentary Maculopathy?
Maculopathy is a disease that affects the macula, which is a spot on the retina that sees vision the keenest. Researchers found that Elmiron toxicity could cause a unique pigmentary maculopathy in patients who took Elmiron for long periods of time. Because of its uniqueness, this form of maculopathy is often mistaken for a different type of eye condition, such as macular degeneration, especially since many patients who take Elmiron for interstitial cystitis are older.
Symptoms of Pigmentary Maculopathy
The primary symptoms of Elmiron-related pigmentary maculopathy are blurred vision, dark adaptation taking longer periods of time, and metamorphopsia, which is vision distortion that causes those suffering from it to see straight lines in a grid as wavy or even blank.
Ophthalmologists have found that subtle changes in the pigmentation of the macula had occurred and that abnormalities appeared on tests. The changes in pigmentation that occur in the macula are spots of hyperpigmentation, or spots that appear darker than the surrounding area. These spots were also accompanied by spots of light yellow or orange.
Despite the evidence linking Elmiron to eye damage, the FDA has not issued a recall of the drug. Nor has the FDA issued a warning to alert patients of the risks of taking Elmiron long-term. Elmiron is still the only drug available to treat interstitial cystitis. There’s not even a generic version of the drug available within the United States. This means that patients could be taking the drug for years without realizing the damage it could do to their eyes. It also means that doctors could continue prescribing the drug without knowing and then mistake the symptoms for another eye condition like macular degeneration.
On March 26, 2020, a lawsuit against the manufacturers of Elmiron, Teva Branded Pharmaceuticals R&D and Janssen Pharmaceuticals, was filed in Connecticut. The lawsuit is on behalf of several patients who have taken Elmiron for extended periods of time to treat interstitial cystitis and have experienced vision loss and retinal damage as a result.
If you or a loved one has taken Elmiron for long periods of time to treat interstitial cystitis, or Painful Bladder Syndrome, and has experienced eye damage and vision loss because of it, you may have a case against the company that produced the drug. Despite the known links between long-term use of Elmiron and damage to the macula in the eye, which includes vision loss, the drug continues to be manufactured and sold. The FDA has not issued a recall or even a warning.
Let us help you fight against the companies that choose profits over people’s health. Farah & Farah’s highly skilled team of lawyers is experienced in drug lawsuits against pharmaceutical companies. Don’t wait to seek the justice and compensation that you deserve. Contact us today for a free consultation. You pay absolutely nothing unless your case is successful.