Janssen Pharmaceuticals Finally Adds Eyesight Damage Warning To Elmiron Label

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According to research studies, many people who have taken the drug Elmiron for a painful bladder condition called interstitial cystitis (IC), have developed significant retinal damage, which may cause permanent vision loss. 

For years, Janssen Pharmaceuticals, the manufacturer of Elmiron and a subsidiary of Johnson & Johnson, excluded permanent vision loss in the drug’s list of side effects. 

However, because of mounting lawsuits, studies and articles (such as this one published in Science Daily), and pressure from consumers via an FDA citizens petition, Janssen Pharmaceuticals recently updated the list of Elmiron side effects. 

New Elmiron Warning 

The following is the updated, full warning from Elmiron’s package insert and product monograph

“Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® … Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.

“Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment.

“Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment.

“If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

Eye Damage Not Necessarily From Long-Term Use, New Users May Be At Risk

The article, Lawsuits Mounting Over Eye-Damaging Elmiron, discusses how taking Elmiron for a long period of time can lead to the eye disorder, maculopathy. However, Elmiron has also caused vision problems in people who have only taken the drug for a short while, sometimes within the first year of taking the drug. 

At the conclusion of the article, there is the option to get a free case review if you have a history of using Elmiron for IC. 

According to ScienceDaily, if identified early, the damage may be mitigated by discontinuing the usage of Elmiron. However, with long-term use, toxicity can mimic late-stage dry atrophic age-related macular degeneration and result in permanent vision loss.

Interstitial Cystitis Sufferers Rejoice at Updated Warning

As for the updated warning, a website devoted to interstitial cystitis says:

“This is a tremendous success. We believe that it is vital that patients know the full risks vs. benefits of any medication that they are considering. For some patients, long-term Elmiron use has led to significant, potentially permanent, vision changes and/or blindness. It encourages urologists to ask patients if there is any family history with eye disease and recommends baseline retinal examinations for every patient within six months of beginning ELMIRON® treatment and on an on-going basis to determine if their retinas are being effected [sic].”

You can read the full article on the IC Network here.

Proper Dosage Unknown, Problems May Develop After Drug Is Discontinued

If you take Elmiron, ask your physician if he or she is aware of the latest research and problems associated with the drug. The most recent study was published July 9 in JAMA Ophthalmology. The research suggests that damage to the macula, which is the functional center of the retina and processes sharp, clear, straight-ahead vision, may occur after discontinuing Elmiron. Furthermore, neither a uniform safe dosage, a cumulative safe dosage nor the safe length of time taking the drug has been established. Make sure both you and your doctor are weighing the pros and cons of taking the drug. Having to go to the bathroom more often and putting up with a little discomfort (if your IC condition is not severe) is better than going blind. 

Have You Been Injured By Elmiron? Get A Free Case Review

If your eyesight has been damaged by Elmiron, you may be eligible for a free case review to see if you are eligible for financial compensation.

Get My Free Case Review


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