Elmiron is the only drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of a painful bladder condition known as interstitial cystitis. However, side effects of Elmiron may lead to vision loss and eye damage for a significant percentage of those who take it.

What Is Elmiron?

Elmiron for interstitial cystitis is a prescription medication manufactured by Janssen Pharmaceuticals and approved by the FDA in 1996. The drug, pentosan polysulfate sodium, is taken orally and designed to treat interstitial cystitis’s painful symptoms. There are other drugs that can be used to relieve certain symptoms of interstitial cystitis, but Elmiron is the only drug approved to treat the condition, which affects between four million and 12 million people in the U.S., according to the Interstitial Cystitis Association. There is no generic version of Elmiron.

Elmiron was originally developed by Teva Pharmaceuticals, which was at the time licensed to Janssen Pharmaceuticals, a subsidiary of pharmaceutical giant Johnson & Johnson. Now, Janssen is both the manufacturer and distributor of Elmiron.

What Is Interstitial Cystitis?

Interstitial cystitis is a chronic bladder condition that causes bladder pain, bladder pressure, and pelvic pain. The pain may come and go and may range from mild to severe. Those who suffer from the condition may also feel the need to urinate more frequently and may produce a smaller output of urine. Pain may flare up after urinating and during sexual intercourse and some with the condition have also reported a burning sensation in the bladder and/or waking at night to urinate.

Although interstitial cystitis affects any gender, it is more common in women. Its cause is not known, although it appears that age, sex, skin color, and hair color may play a role. Additionally, having another chronic pain disorder may make increase the odds of developing interstitial cystitis.

It is thought that those with the condition suffer damage to the bladder’s protective lining, which may allow irritating substances in the urine to cause inflammation in the bladder wall.

There is no cure for interstitial cystitis, although medications and therapies may ease some of the symptoms. Without treatment, it may be debilitating and greatly reduce the patient’s quality of life.

Using Elmiron for Interstitial Cystitis

While Elmiron is not a cure, it may provide relief from some of the symptoms associated with the condition. It is believed that Elmiron works by coating the bladder wall and thus protecting it from irritants. This decreases inflammation and resulting pain, however, Elmiron may have serious side effects.

Elmiron Side Effects

One of Elmiron’s most common side effects is hair loss, or alopecia. In one study, 97% of patients who experienced alopecia after taking Elmiron for interstitial cystitis experienced hair loss in a single spot. The hair loss was generally reversed once patients ceased taking the drug. Other common side effects include diarrhea, nausea, headache, rash, and upset stomach. While these side effects may be minor, Elmiron has also been linked to a serious eye disease known as macular degeneration.

Elmiron Macular Degeneration Links

According to research into Elmiron’s side effects, the drug may be toxic to the retina, the part of the eye that senses light and allows people to see. Long-term Elmiron usage may result in damage to the macula, the central part of the retina. This part of the eye is responsible for crisp and clear vision, the ability to read, and the ability to discern fine details.

When the macula is damaged, it may make it difficult to read, adjust to changes in light, and partial or full vision loss. Many patients have reported blurry vision, blind spots in their central vision, or difficulty seeing details or colors.

Macular degeneration develops over time, and symptoms gradually worsen. The best way to detect and diagnose this issue early on is to have regular eye examinations with an ophthalmologist, and keep an eye out for these noticeable symptoms:

• Blurred central vision
• Difficulty reading
• Blurred, dark, or empty spots
• Distortion (objectively straight lines appear bent or wavy)
• Trouble recognizing faces

Unfortunately, macular problems may be linked to long term Elmiron usage. Although the damage caused by Elmiron does not appear to be reversible, it may be possible to stop the damage from increasing if patients cease taking the drug.

The link between Elmiron and eye disease was brought to light in 2018 by a Georgia doctor who saw six patients with macular damage and related vision problems. All six of these patients had been taking Elmiron for interstitial cystitis for about 15 years.

Since then, other doctors have heeded this new information and looked at their own patients for signs of Elmiron eye problems. Unfortunately, this has reportedly yielded new cases to support the trend.

For the October 2019 meeting of the American Academy of Ophthalmology, three ophthalmologists from Kaiser Permanente presented their findings after looking at Kaiser’s 4.3 million patient database. Of these patients, they found over 140 who had taken Elmiron long term (an average of 5,000 pills over 15 years). 91 of the patients agreed to be seen by the doctors to screen for Elmiron eye problems.

The researchers found that damage to the retina affects some 25% of long-term Elmiron users. In the study of 91 patients who took Elmiron for interstitial cystitis, 22 were found to have suffered toxicity.

The rate of toxicity in these patients reportedly rose with the amount of the drug taken. For patients who took between 500 to 1,000 grams of Elmiron, 11 percent showed toxicity. For patients who took 1,500 grams of more, 42 percent showed toxicity.

Since most Elmiron users take the drug for years or decades, and because long-term use increases risk, maculopathy may end up affecting a significant percentage of patients.ff

“It’s unfortunate,” researcher Dr. Robin A. Vora, M.D. said, according to Science Daily. “You have a patient with a chronic condition like interstitial cystitis, for which there is no cure and no effective treatment. They get put on these medications because it’s thought to have few side effects and few risks, and no one thinks about it again. And year after year, the number of pills they’re taking goes up and up.”

There are a few risk factors that have been identified that may increase the probability of developing macular degeneration, including age, genetics, race, and smoking history.

How to File an Elmiron Lawsuit

A growing number of patients have come forward with litigation alleging that taking Elmiron for interstitial cystitis has caused significant side effects, including macular degeneration. Lawsuits claim that Elmiron was intended for long-term use, yet the long-term use of the drug leads to a higher risk of these medical complications.

If you have taken Elmiron for interstitial cystitis and have suffered Elmiron maculopathy or vision loss, you may be eligible to speak with an experienced attorney about your legal options. Joining or filing a class action lawsuit against the drug’s manufacturer may be an option.

Filing a lawsuit cannot take away the pain and suffering caused by such vision problems, but it can at least help with the financial burden caused by these issues. Those who have been harmed by Elmiron may be able to recover compensation for medical expenses, injuries, and pain and suffering.

Filing a lawsuit can be a daunting prospect, especially while dealing with medical issues, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.