ROSENBAUM & ROSENBAUM, P.C. | March 10, 2021 | Products Liability
The Food and Drug Administration (FDA) requires that labels for the prescription drug Elmiron warn prescribing physicians and patients of the dangers of taking the drug. The primary adverse reactions include changes in vision, alopecia, thrombosis, and hemorrhage. Studies show that the long-term use of Elmiron increases the risk of serious issues.
For some, the side-effects of Elmiron have become so severe that they have pursued product liability claims against the makers of the drug.
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 everyone who takes Elmiron receive a comprehensive retinal examination that includes three specialized retinal procedures. Also, the FDA urges doctors to re-evaluate the risks and benefits of continuing Elmiron therapy after a patient develops pigmentary changes to the retina.
Retinal and vision changes can continue to worsen even if the patient stops taking Elmiron. The patient can develop a progressive eye disease that can include loss of nighttime vision, dark spots, loss of detailed vision, blurry vision, and 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. As with other blood thinners, Elmiron carries a risk of hemorrhage. Bleeding of the gums is a reported side effect of Elmiron. Also, 6.3 percent of people who take Elmiron report having rectal hemorrhage.
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.
The Mayo Clinic describes alopecia areata as sudden hair loss that begins as one or more round patches of baldness. Sometimes, the skin becomes painful or itchy before the hair falls out.
Clinical Trials of Elmiron for Treating Interstitial Cystitis
The FDA reports that Elmiron pills are similar to the blood-thinner heparin. According to the FDA, how pentosan polysulfate sodium (Elmiron) works to relieve the symptoms of interstitial cystitis is unknown, even though the drug is approved to treat the condition.
The FDA reported on two clinical trials that evaluated how well Elmiron relieved pain in patients with chronic interstitial cystitis. The study followed 155 patients, approximately half of whom received Elmiron and about half received a placebo.
The patients did not know whether the pills they received were the drug or the placebo. The patients assessed the effect of the pills on their bladder pain. Thirty-eight percent of the study participants who took Elmiron claimed to have bladder pain reduction of more than 50 percent, while 18 percent of the placebo-taking patients reported a drop in bladder pain of more than 50 percent.
The second study assessed the long-term effectiveness of Elmiron on the treatment of chronic interstitial cystitis. This clinical trial began with 2499 patients. Before the end of the first three months, 52 percent had dropped out of or were ineligible for continuing in the study.
Six months into the trial, 64 percent of the participants had dropped out 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.
A paltry five percent of all the original study participants said that their bladder pain or interstitial cystitis discomfort improved when taking Elmiron. Nonetheless, the healthcare industry considers Elmiron an effective treatment for bladder pain.
The vision changes that can be the result of taking Elmiron for interstitial cystitis are sometimes called “Elmiron Maculopathy.” Elmiron Maculopathy can include a variety of eye diseases and damage, including:
- Macular degeneration
- Retinal deterioration
- Macular retinopathy
- Pigmentary maculopathy
- Pattern dystrophy
- Other types of maculopathies
Critics argue that the drug maker, Janssen Pharmaceuticals, should have issued warnings about the risk of eye damage much earlier. If people had been informed of this risk, they could have avoided serious issues associated with the long-term use of Elmiron.