BY: Attorney Mark Wolfe

Elmiron is an oral medication approved by the FDA to treat the pain and discomfort of the bladder condition known as interstitial cystitis (IC). Numerous recent medical studies have now been released that have linked those who have taken Elmiron to a vision loss condition known as pigmentary maculopathy. Maculopathy is a pathological condition of the macula, which is the area of the retina that is associated with highly sensitive and accurate vision. In the case of those who have taken Elmiron, there is evidence that a buildup of pentosan polysulfate sodium, the active ingredient in Elmiron, in the retinal cells causes these irreversible vision problems. These problems appear to be more common with women who have used Elmiron.

Elmiron has not been recalled despite studies linking long-term use of the IC drug to potentially permanent vision damage. The drug is manufactured by Janseen Pharmaceuticals (Janssen). Janssen is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. The drug has been on the market since 1996. However, Janssen did not warn about the risk of retinal pigmentary maculopathy until it updated the drug’s prescribing information at the direction of the FDA in June of 2020. The FDA published the new label with the maculopathy warning but it has not issued a statement or safety communication about it. At this point, the agency has not required Janssen to recall the drug and the drug maker has not said it plans to issue a voluntary recall.

Some of the most common symptoms associated with pigmentary maculopathy include the following:
– Difficulty reading
– Blindness
– Eye pain
– Difficulty adapting to dim lighting
– Vision disturbances or distorted vision, or
– Trouble seeing things up close

If you or a loved one has suffered vision loss or vision difficulty and taken the drug Elmiron before June 2020, you may have a claim for compensation and restitution. Please call Mark Wolfe at Boteler Richardson Wolfe – Injury Lawyers today. 251 410-7761. Or email Mark at, please put “Vision Loss Claim” in the subject line. Consultations are always free. Boteler Richardson Wolfe – Injury Lawyers have been helping people with injury claims and cases since 1987. Our lawyers are licensed in Mississippi, Alabama, Florida and Georgia.

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