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Elmiron, a drug used to treat interstitial cystitis, a painful bladder condition, has been associated with eye damage and loss of vision. A 2018 study revealed ocular risks associated with Elmiron, leading to a 2019 FDA warning.

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Taking any medication involves risks. Most of the time, the risk of taking a medication is outweighed by the benefits. When medications are prescribed by a medical professional who understands your health history and medical needs, they are usually safe to take.

Sometimes drug manufacturers discover new risks associated with a medication. Or, sometimes drug manufacturers know about a risk related to the medication but fail to warn the public about it.

This can lead to some people developing serious health complications or negative outcomes. This can also result in drug recalls and lawsuits related to specific medications. Elmiron is one medication that may be linked to serious health problems. One major concern is the link between eye damage and Elmiron.

What is Elmiron, and What Is It Used For?

The generic name for Elmiron is pentosan polysulfate sodium. Elmiron was first approved by the Food and Drug Administration (FDA) in 1996. The main manufacturer of Elmiron is Johnson & Johnson.

Elmiron is used to help relieve symptoms related to the condition interstitial cystitis. Interstitial cystitis is when the bladder becomes inflamed. This can cause symptoms like bladder pain and discomfort.

The CDC notes that interstitial cystitis is a chronic condition that tends to affect more women than men. It is still unclear what actually causes interstitial cystitis. Some symptoms of interstitial cystitis include frequent urination, pain in the bladder or pelvic region, and severe abdominal pain as the bladder is emptied or filled.

Possible Elmiron Complications

When you take a medication, you may experience some side effects. Side effects can range from rare and minimal to common and severe. Sometimes the term adverse event is used to refer to more severe side effects.

As noted by the Mayo Clinic, it is possible to have an allergic reaction to Elmiron. Tell your doctor about any allergies you have before taking any new medications. It may also be unsafe to combine certain medications. Elmiron has the potential to react with some other prescription drugs. Make sure to tell your doctor about any medications you are currently taking.

Depending on what you take, your doctor may decide to change the dosage of your medication or to prescribe a different medicine.

Sometimes if you have certain medical conditions, Elmiron will impact your body differently. For example, if you have any abnormal bleeding conditions or vision problems, Elmiron make these problems worse. If you have liver disease, the effects of Elmiron may be more intense, as the medication stays in your body for longer.

Before starting any new medications like Elmiron, make sure to tell your doctor about your health history. Be as honest as you can to give your doctor access to thorough data. This includes disclosing any history of vision problems.

Elmiron Side Effects and Adverse Effects

Side Effects

Some side effects are minimal and only cause minor discomfort. You should always tell your doctor about any side effects or reactions you experience, particularly if they are severe or continuing.

Some side effects are more minor and can include the following:

  • Diarrhea, upset stomach, or stomach pain
  • Heartburn
  • Hair loss
  • Headache
  • Skin rash
  • Problems falling asleep or staying asleep
  • Moodiness
  • Dizziness

Adverse Events

It is possible to experience severe adverse effects while taking Elmiron. Some problems are related to blood clotting, which can be a serious concern. Make sure to tell your doctor if you notice any usual bleeding. This could include things like bleeding gums, having black, tarry stool, or seeing an increase in nosebleeds.

Other more severe side effects may include:

  • Chest pain or tightness
  • Difficulty swallowing or breathing
  • Fast heartbeat

Elmiron may also cause vision problems and eye damage. There is even the risk for blindness. Tell your doctor if you have any symptoms of vision changes such as blurred vision or if you find that it takes longer than normal for your eyes to adjust to different lighting.

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History of Elmiron

The FDA first approved Elmiron for use in 1996. Because it has been on the market for several years, many people have taken Elmiron. It is a highly popular treatment for interstitial cystitis.

In 2018, a study was published that suggested people taking Elmiron could be at risk for eye damage. The American Academy of Opthalmology further confirmed this suspicion in 2019.

In 2019, the FDA issued a warning about vision problems related to taking Elmiron. At this time, the FDA evaluated the need for action regarding new regulations.

In 2020, the FDA further added a specific warning to the Elmiron medication label about the risk of pigmentary maculopathy. The warning recommended that anyone taking Elmiron report any vision changes to his or her doctor and eye doctor and that patients should be sure to get regular eye exams, including retinal screenings.

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