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Is Elmiron Safe?
Everything You Need To Know

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C.L. Mike Schmidt Published by C.L. Mike Schmidt
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Elmiron is a medicine used to treat bladder pain. It forms a layer around the wall of the bladder to protect the bladder from harmful urine substances.

However, claims have surfaced recently stating that taking Elmiron isn’t safe. 

Schmidt & Clark’s lawyers have helped countless people get damages after suffering consequences from defective medical devices and unsafe medication. Today, we’ll explain if Elmiron is safe and if you qualify for an Elmiron lawsuit.

Summary of the Key Findings

  • Elmiron is a drug used to alleviate bladder pain.
  • Recent research, such as one done by the Emory Eye Center, found that long-term use of Elmiron can cause retinal maculopathy.
  • You should consult a lawyer to help you get damages if you’ve experienced side effects due to Elmiron use.

What Is Elmiron, and Is It Safe?

Elmiron close up image Elmiron, also called pentosan polysulfate sodium (PPS), is the drug manufactured by Janssen Pharmaceuticals, and it’s generally considered safe. 

It’s approved by the FDA and prescribed for treating pain and bladder discomfort associated with interstitial cystitis (IC). It forms a thin layer in the bladder wall to protect the bladder from being irritated by the harmful substances found in urine.

Men and women suffering from interstitial cystitis can use Elmiron, but it more commonly happens to women. Between 3 and 8 million women in the US have interstitial cystitis, and between 1 and 3 million men [1].

Elmiron has been used for decades, but some new reports say long-term use of this medication isn’t safe. Some patients who’ve used Elmiron pentosan polysulfate sodium have experienced eye problems, especially retinal maculopathy, and retinal pigmentary endothelium injury.

The researchers at Emory University Medical School in Atlanta, Georgia, were the first to discover the connection between Elmiron and eye disorders. They studied people being treated for interstitial cystitis with Elmiron and found that people who used this drug long-term (between 2015 to 2017) were at a higher risk of having retinal maculopathy [2]

A more recent study done in 2019 by the American Academy of Ophthalmology researchers found links between changes in vision and Elmiron [3].

Nowadays, it’s known that taking Elmiron to treat pain in the bladder can lead to eye problems and potentially permanent vision loss in some cases.

What is Interstitial Cystitis?

Woman having abdominal pain in bed Interstitial cystitis is a chronic bladder condition. People with this condition experience pelvic pain and bladder pressure, and they need to urinate frequently. Pain is especially noticeable during urinating and sexual intercourse. 

It’s unknown why interstitial cystitis happens and why it occurs more commonly in women than men. 

People with interstitial cystitis experience damage to the bladder’s protective lining, resulting in certain substances in the urine causing inflammation of the bladder wall. 

The cause of the condition is unknown, but some researchers think it’s related to age, sex, diet, and certain activities.

Currently, there’s no cure for this condition. Elmiron is the most commonly prescribed medication and the only one approved by the FDA. Elmiron doesn’t cure interstitial cystitis, but it relieves some of the symptoms.

Side Effects of Using Elmiron

Most people will experience mild side effects that stop once the body is used to the medication. However, some clinical trials have shown long-term side effects. 

The most common Elmiron side effects that healthcare professionals warn about are:

  • Woman having hair loss after combing hair Hair loss
  • Nausea
  • Dizziness 
  • Headache
  • Diarrhea
  • Rash
  • Upset stomach 
  • Abdominal pain
  • Depression
  • Bruising
  • Blood in stool

Other rare side effects that a healthcare professional warns about are:

  • Weight gain
  • Allergic reactions
  • Colitis constipation
  • Pink eye
  • Itchy skin
  • Symptoms resembling cold
  • Blood abnormalities such as anemia
  • Ringing in the ears
  • Voting
  • Breath shortness 
  • Retinal hemorrhage
  • Mouth ulcers

People who used Elmiron for bladder pain syndrome most commonly experienced these vision impairment issues:

  • Woman hurting her eye while reading on a laptop Slow adjusting to low light conditions
  • Blurred vision
  • Difficulty reading
  • Dark spots in the center of the vision
  • Straight lines appear curved
  • Colors are less vivid
  • Halo vision
  • Blindness 
  • Maculopathy
  • Pigmentary maculopathy
  • Retinopathy
  • Scotoma

Out of all of the retinal damage that Elmiron can cause, retinal maculopathy is seen as one of the most serious side effects.

Its symptoms include:

  • Eye pain
  • Irregular vision
  • Changed vision in low light condition
  • Permanent vision loss 

If you notice any adverse effects of Elmiron while taking this medication, call your eye doctor straight away and schedule laboratory tests. In general, it’s a good idea to have an eye exam every six months from starting the treatment with Elmiron.

“Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes. Your doctor will discuss with you when to get your first eye examination and follow-up exams, and whether the treatment should be continued.” Elmiron Official Website

Elmiron side effects can be especially damaging if you have:

  • Bleeding disorders — Elmiron is a blood thinner, so you should stop using it if you’ve had surgery or are taking other drugs that increase bleeding.
  • Elevated liver enzymes — Some users experience elevated liver enzymes, and the effects persist up to a year after starting medication. If you have liver problems, Elmiron can make the situation worse.
  • Pregnancy and breastfeeding — According to the label, Elmiron should be used during pregnancy only when the doctor approves it. Research on pregnant women taking this medication still hasn’t been done, so it isn’t known if it causes impaired fertility. However, as drugs can be excreted through human milk, women who are breastfeeding shouldn’t use the medication.

Who Qualifies for an Elmiron Lawsuit?

A session with a lawyer when client filing a lawsuitPeople who have taken the medication for at least two years and are diagnosed with eye disease, such as maculopathy, qualify for an Elmiron lawsuit. 

If you have any of the symptoms listed above, you should visit your healthcare provider and an ophthalmologist to get an official diagnosis.

You are eligible for a lawsuit and damages once you’re diagnosed with a chronic condition or an eye disease due to Elmiron usage. 

After getting an official diagnosis, you should hire an attorney. In recent years, a number of patients have sued the company behind Elmiron, and your lawyer can sue Janssen Pharmaceuticals on the grounds of potential negligence.

The lawyer can claim the drug was intended for long-term use, but long-term use leads to an increased risk of medical complications. 

Damages in Elmiron Lawsuits

An attorney can help you join a legal class action lawsuit and get damages. This won’t take away all the pain and suffering you’ve gone through due to vision problems, but you can get help with the financial expenses.

The lawsuit is valued at the total losses you had because of the injury you sustained. 

Damages you can get include:

  • Expenses for medical treatments; past and future.
  • Pain and suffering. This includes both mental and physical pain.
  • Lost wages due to inability to work because of the vision changes.
  • Loss of future earnings, in case your ability to work is lost.
  • Loss of life enjoyment.
  • Tangible and intangible costs.

A lawyer can help you calculate the extent of the damages and the amount you can get.

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How Long Should You Take Elmiron?

You should take Elmiron for at least 6 to 8 weeks. You won’t experience relief from symptoms if you take the medication for a shorter period. For persistent relief, you should continue the therapy for longer than this.

What Happens if I Miss a Dose?

In case of a missed dose, you should take medicine as soon as you can. Skip the dose if it’s almost time for the next dose, and never take two doses at a time.

Should You Take Elmiron?

Elmiron can help alleviate pain in the bladder, and the medication doesn’t list other drug interactions, so it should be safe to use with other medications and herbal supplements. Make sure to consult your doctor about the Elmiron use. 

However, recent research linked Elmiron with serious side effects, such as loss of eyesight and various eye diseases. If you experience any side effects, you should contact your doctor straight away.

You should also hire a trustworthy lawyer to help you get damages. Schmidt & Clark, LLP lawyers have years of experience helping many patients who suffered health issues due to faulty medication.

Contact us today for a free case evaluation.





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