Studies Show Long Term Use Of Elmiron Increases Risk Of Serious Issues

The Food and Drug Administration (FDA) mandates that labels for the prescription drug Elmiron include a warning about the drug’s risks to prescribing physicians and patients. The most common adverse reactions include vision changes, alopecia, thrombosis, and bleeding. Studies indicate that long-term Elmiron use increases the risk of serious side effects.

Retinal Pigmentary Changes With Elmiron

The FDA says that people who take Elmiron long-term can experience changes in the pigment of the retina, leading to vision changes. Most, but not all of these adverse reactions, happened in patients who used Elmiron for three years or longer. The studies did not reveal how or why FDA-approved Elmiron causes this condition, called pigmentary maculopathy, but it appears that cumulative doses contribute to the complication.

When a person develops pigmentary maculopathy from taking Elmiron, the patient can have blurred vision, difficulty reading, and struggle to adjust to low light environments. The studies indicate that the damage to the retina can be permanent and irreversible.

The FDA recommends that all Elmiron patients undergo a comprehensive retinal examination comprising three specialised retinal procedures. In addition, the FDA urges physicians to reevaluate the risks and benefits of continuing Elmiron therapy in patients with retinal pigmentary changes.

Retinal and visual changes may continue to worsen even if the patient discontinues Elmiron treatment. The patient may develop a progressive eye disease that causes night vision loss, dark spots, loss of detail, blurred vision, and eventual blindness.

Sometimes the retinal damage does not happen until after the person stops taking Elmiron. Elmiron patients who do not experience symptoms of eye damage should have a thorough retinal examination every six months while taking Elmiron and after stopping treatment.

Hemorrhage Risk of Taking Elmiron

Elmiron works as an anticoagulant and breaks down blood clots. Elmiron, like other blood thinners, poses a risk of haemorrhage. Bleeding of the gums is a reported side effect of Elmiron. Additionally, 6,3 percent of Elmiron users report rectal haemorrhage.

Elmiron and Alopecia

Another distressing complication of Elmiron is alopecia, which happened within four weeks of starting treatment during the clinical trials of the drug. Almost all cases of alopecia that developed during the clinical trials were alopecia areata.

According to the Mayo Clinic, alopecia areata is an abrupt hair loss that manifests as one or more round patches of baldness. Sometimes, the skin becomes itchy or painful before hair loss.

Clinical Trials of Elmiron for Treating Interstitial Cystitis

According to the FDA, Elmiron pills are comparable to the blood thinner heparin. The FDA does not know how pentosan polysulfate sodium (Elmiron) relieves the symptoms of interstitial cystitis, despite the drug’s approval for treating the condition.

The FDA reported on two clinical trials that evaluated how well Elmiron relieved pain in patients with chronic interstitial cystitis. Approximately half of the 155 patients in the study received Elmiron, while the other half received a placebo.

The patients were unaware of whether the pills they received contained the actual medication or a placebo. Patients evaluated the effectiveness of the medication on their bladder pain. 38 percent of study participants who took Elmiron reported a reduction in bladder pain of more than 50 percent, while 18 percent of placebo-treated patients reported a reduction in bladder pain of more than 50 percent.

The second study evaluated the long-term efficacy of Elmiron for treating chronic interstitial cystitis. This clinical trial initially enrolled 2499 patients. Before the end of the first three months, 52 percent of participants had dropped out of the study or were ineligible to continue.

Six months into the study, 64 percent of participants had withdrawn or lost eligibility. Fewer than one-fourth of the original study participants stayed in the clinical trial for one year. Only 13 percent of the patients who stayed in the study for six months reported bladder pain relief.

Five percent of the original study participants reported that Elmiron alleviated their bladder pain or interstitial cystitis discomfort. However, the healthcare industry considers Elmiron to be an effective bladder pain treatment.

Elmiron Maculopathy

The vision changes that can result from taking Elmiron for interstitial cystitis are referred to as “Elmiron Maculopathy” at times. Elmiron Maculopathy can include a variety of eye conditions and damage, such as:

  • Macular degeneration
  • Retinal deterioration
  • Macular retinal disease
  • Pigmentary maculopathy
  • Pattern dystrophy
  • Other types of macular disorders

Critics argue that the drug manufacturer, Janssen Pharmaceuticals, should have issued much earlier warnings about the risk of eye damage. If people had been made aware of this risk, they could have avoided serious problems associated with Elmiron use over the long term.

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