Elmiron is a medication for treating pain and discomfort associated with interstitial cystitis (IC). Most of the adverse effects of Elmiron are minor and go away once the body adjusts to the medication. Most people have a good tolerance for the drug.
In clinical studies, the longest time researchers have to observe study subjects is one year. The most common adverse effects of Elmiron are dehydration, nausea, hair loss, diarrhoea, and severe abdominal discomfort.
What is Elmiron?
The National Organization of Diabetes and Digestive and Kidney Diseases displays that 3 to 8 million women and 1 to 4 million men grieve from IC, a chronic bladder disease.
Elmiron, often called pentosan polysulfate sodium, is a prescription medication approved to treat interstitial cystitis associated with discomfort and pain. It also works as a minor blood thinner.
Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, makes this drug. It was approved for use by the U.S. Food and Drug Administration in 1996. It remains the only approved oral treatment for bladder uneasiness and pain caused by interstitial cystitis.
Nausea, diarrhoea, and hair loss are common adverse effects. Bleeding and eye problems are essential but rare side effects.
Common Elmiron Adverse Effects
Based on the drug’s prescription requirements, researchers analyzed the adverse effects of Elmiron in 2,627 people. Between one and four per cent of subjects reported experiencing common side effects.
Thirty-three people, or about 1.3%, experienced serious adverse effects. Six people died. However, it appears that they did so because of other medical problems.
The most frequently reported adverse effect is alopecia or hair loss. Within four weeks of using the conduct, hair loss began. In about 97% of people with alopecia who report cases, there is only one area of hair loss. The hair grew back after the medication was stopped.
The most common side effects in another clinical study involving 2,499 patients with interstitial cystitis were diarrhoea (4%), hair loss (4%), and nausea (4%).
Elmiron Rare Side Effects
The drug’s prescribing advice states that 1% or less of trial participants experience unusual adverse effects.
Rare but thoughtful side effects of Elmiron include:
- Allergy symptoms and photosensitivity.
- A blood disorder called anaemia.
- Retinal hemorrhage
- Mouth ulcers
- Difficulty breathing
- Itchy skin
- Constipation from colitis
- Vomiting
- Evident in the auricles (tinnitus)
- Conjunctivitis (pink eye)
- Cold-like signs
Side Effects of Elmiron Described to the FDA
A search for “Elmiron” and “pentosan polysulfate sodium” in postmarketing numbers on the FDA’s Adverse Event Reporting System (FAERS) Dashboard from 1997 to June 30, 2020, turned up 2,570 reports of reactions.
Of those complaints, 1,748 were serious, and 24 persons died as a result. The Diet and Drug Administration (FDA) cannot approve whether the drug caused an adverse reaction because FAERS data comes from voluntary reporting. There are 202 eye conditions recorded. These include visual impairment, maculopathy, and blurred vision.
On FAERS, the top five adverse events are:
- Alopecia, 252
- Diarrhoea, 166
- Headache, 173
- Dizziness, 120
- Nausea, 156
Lawsuit Against Elmiron Manufacturers
Attorneys estimate that as of September 2020, there were 50 lawsuits nationwide, with the Eastern District of Pennsylvania hosting nearly half of them. They predict more cases will emerge. Learn more about the Elmiron case here.
Conclusion
Elmiron is no longer remembered. An investigation conducted between 2018 and 2020 found that the drug was linked to potentially permanent vision problems. Ophthalmologists have linked long-term use of the drug to a rare form of pigmentary maculopathy.
In June 2020, Janssen included a warning about retinal pigmentation changes, but the Food and Drug Administration has not yet issued a safety approval or suggested a recall.
Patients who took Elmiron and experienced vision loss sued Janssen Pharmaceuticals. According to Elmiron’s complaints, the pharmacist knew the drug could lead to vision problems but failed to inform patients and doctors.