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Food and Drug Administration approves Elmiron label changes

On Behalf of | Jul 9, 2020 | Pharmaceutical Litigation

Ohio residents suffering from a particular bladder disorder may take Elmiron for the pain and discomfort associated with it. They may or may not know that certain previously unknown and/or unreported dangers from extended Elmiron use became known in recent years. This medication comes with some significant side effects, but up until now, the labels have not indicated that prolonged use could lead to vision problems, including blindness. Only recently did the Food and Drug Administration approve a new label that includes these issues as side effects.

The drug appears to have a cumulative effect in the body, which is why the vision problems may not manifest for months or years. Most people involved in a study regarding this issue took the medication for at least three years before having trouble reading or blurred vision. Patients also complained of their eyes taking longer to adjust to reduced or low light environments. Retinal pigmentary changes can also occur and may serve as a warning sign of more degenerating effects to come.

The new warnings recommend that patients begin to evaluate their eyes six months after starting Elmiron and continue as long as they take the medication. If changes do occur, the need for the medication should be reevaluated. The research so far indicates that any damage already done cannot be reversed, but further damage could be avoided if the patient stops taking it.

The fact that the Food and Drug Administration approved the label changes in order to warn health care professionals, pharmacists and patients of the danger of serious vision problems is a good thing. However, it may be too late for some people. Ohio residents who take Elmiron and experience issues with their vision may want to contact their doctors right away.


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