NC Elmiron Lawsuit

Elmiron is a commonly prescribed drug for the treatment of bladder pain associated with interstitial cystitis (IC) and less frequently for the treatment of osteoarthritis. Elmiron contains the active ingredient pentosan polysulfate sodium and is the only FDA-approved pill to treat IC. However, published medical studies have linked Elmiron to serious retinal damage and vision loss.

Multiple Elmiron users have filed product liability lawsuits seeking compensation for injuries and other losses they have suffered due to the previously undisclosed risk of side effects from this dangerous drug. Due to the numerous people who have filed Elmiron lawsuits because of drug side effects, the claims against Janssen Pharmaceuticals could become a class action lawsuit or multidistrict litigation (MDL).

The dangerous drug attorneys at Younce, Vtipil, Baznik & Banks, P.A., are investigating complaints of retinal damage and vision loss among users of Elmiron. If you have experienced any adverse side effects associated with Elmiron, you should contact a dangerous drug lawyer in North Carolina by calling 919-661-9000. Please contact Younce, Vtipil, Baznik & Banks today for a free review of your legal options. If you are taking Elmiron, do not stop taking the medication immediately but consult your doctor about your use of Elmiron.

What is Elmiron Used For?

The Mayo Clinic describes interstitial cystitis (IC) as a chronic condition causing bladder pressure, bladder pain and sometimes pelvic pain. The pain ranges from mild discomfort to severe pain. The condition is a part of a spectrum of diseases known as painful bladder syndrome.

In addition to pain, IC typically causes the individual to feel the need to urinate more often and then to produce smaller volumes of urine than most people. The condition most often affects women but can be diagnosed in men, as well. Most people with interstitial cystitis are diagnosed during their 30s or older.

IC may also be referred to as painful bladder syndrome (PBS), bladder pain syndrome (BPS), and chronic pelvic pain.

There is no cure for IC. Medications and other therapies are meant to offer relief from pain.

The Food and Drug Administration (FDA) approved Elmiron as a treatment for the relief of pain and discomfort associated with interstitial cystitis in 1996.

Patients take one 100 mg capsule three times per day. Relief from the symptoms of IC can take three to six months to occur, and patients must remain on Elmiron for continuing benefit.

In June 2020, the FDA approved a new warning on the labeling of Elmiron, informing patients that retinal pigmentary changes, also known as pigmentary maculopathy, a progressive eye disease, is a possible side effect of taking Elmiron.

Elmiron Side Effects: Links to Eye Problems

In 2018, Emory Eye Center in Atlanta, Ga., reported that six patients who had been taking Elmiron for about 15 years had developed unusual changes in their macula, the central part of the retina responsible for delivering clear, crisp, central vison. Afterward, eye doctors at Kaiser Permanente examined 91 patients who had taken Elmiron for 15 years and found “clear signs of drug toxicity” in 22 of them, the American Academy of Ophthalmology reported.

In June 2020, Elmiron maker Janssen Pharmaceuticals updated the drug’s product labeling to warn of vision problems as a possible side effect of taking the medication. The label says taking Elmiron over time can cause changes to pigments in the retina that lead to blurred vision, difficulty reading and slow adjustment to low light.

The warning label states that changes in a patient’s eyesight may be irreversible and can continue to worsen even if the patient stops using Elmiron.

On its website, Elmiron’s manufacturer says the drug’s most common side effects are:

  • Hair loss
  • Diarrhea
  • Nausea
  • Blood in the stool
  • Headache
  • Rash
  • Upset stomach
  • Abnormal liver function tests
  • Dizziness
  • Bruising
  • Weight gain and swelling caused by fluid buildup.

Can Elmiron Cause Blindness or Vision Loss?

Doctors in the Kaiser Permanente study searched Kaiser’s entire database of 4.3 million patients and found 140 patients who had taken an average of 5,000 pills each over the course of 15 years. Of those 140 patients, 91 agreed to an exam.

The three doctors “took detailed images of the back of (each patient’s) eyes and then divided the images into three categories: normal, possible abnormality, definite abnormality.

Twenty-two of the 91 patients showed clear signs of drug toxicity. The rate of toxicity rose with the amount of drug consumed, from 11 percent of those taking 500 to 1,000 grams to 42 percent of those taking 1,500 grams or more,” according to the American Academy of Ophthalmology’s report about the October 2019 study.

The IC Network, a social advocacy health education company dedicated to interstitial cystitis, has published a history of research into the relationship between Elmiron and vision loss due to pigmentary maculopathy. A maculopathy affects the center of the retina and damages vision.

Prior to the Kaiser Permanente study, researchers at the Emory School of Medicine published “Pigmentary Maculopathy Associated With Chronic Exposure to Pentosan Polysulfate Sodium” in the May 2018 Journal of Ophthalmology. The study focused on six women with interstitial cystitis who also had pigmentary maculopathy.

The patients at Emory were tested for any genes associated with hereditary retinal loss, family history of retinal disease or any pathogenic process (disease), and none existed. But each of them had used Elmiron for long periods – a median of 15.5 years.

In May 2019, the Emory team submitted a new study of 10 IC patients who had taken Elmiron and experienced macular disease.

In November 2019, the Harvard Medical School Department of Ophthalmology published a case study that was the first to indicate continued vision loss after discontinuation of the use of Elmiron. A 62-year-old IC patient who has used Elmiron for 18 years suffered from blurry vision in her left eye and difficulty seeing at night. She returned to the clinic six years later, after having quit using Elmiron at age 63, and was found to have significantly more retinal atrophy and damage and worsening vision in both eyes. The patient returned another two years later with even more extensive eye damage.

Your Lawsuit Against Elmiron and Janssen Pharmaceuticals

Pharmaceutical companies have a legal responsibility to ensure that their products are effective and safe when used as directed and to warn consumers adequately of any side effects that the drug causes.

In too many cases, a defective drug’s most harmful side effects are not publicly acknowledged until numerous patients have been injured or died. The law says a drug maker can be held liable for the harm a dangerous drug causes if the manufacturer knew or should have known the drug was harmful and failed to adequately warn consumers.

A patient who has taken Elmiron as prescribed and suffered maculopathy or other vision loss may be able to demand compensation for medical expenses connected to treating their vision, as well as for their pain and suffering and other financial and personal losses.

As your North Carolina dangerous drug injury attorneys, Younce, Vtipil, Baznik & Banks would obtain and analyze your medical records and, if necessary, help you have other tests to rule out genetic or other potential causes of your vision loss. We would gather information about Elmiron and its links to retinal damage, some of which are outlined above.

We may be able to file a lawsuit on your behalf seeking to hold the drug manufacturer responsible for the harm you have suffered. Investigations of pharmaceutical cases often identify numerous patients who have been harmed by a dangerous drug, and the cases become multidistrict litigations. An MDL allows multiple people who have been injured by the same conduct of the Defendant to bring their individual lawsuits where the cases are grouped together.

As a member of the MDL, you would share in any compensation the court ordered Janssen Pharmaceuticals to pay.

Dangerous Drug Lawyers in Raleigh, North Carolina

Younce Vtipil Baznik & Banks personal injury law teamIf you have been prescribed Elmiron for interstitial cystitis (IC) or osteoarthritis and developed pigmentary maculopathy or similar vision loss, you should understand your legal options. The Raleigh defective drug attorneys at Younce, Vtipil, Baznik & Banks, P.A., are ready to help you. We are experienced in taking on large drug companies and are dedicated to helping clients seek full compensation for harm caused by other’s negligence or disregard for safety.

Contact us today to set up a free discussion of your case and the legal options available to you.