One question, from the first study to the label.
A real question, the kind a trial team asks: was the harm knowable before the label warned? The answer cites the 2018 study, FDA’s review of the company’s proposal and the 2020 label.
Ask in plain English.
Was eye damage from Elmiron knowable before the label warned of it?
Yes, in the published literature. A 2018 study in Ophthalmology (Pearce et al.) described a distinctive maculopathy in patients taking Elmiron long-term.
The manufacturer proposed adding a warning on 24 June 2019. FDA approved the change on 16 June 2020, and the label now warns of retinal pigmentary changes in its Warnings section.
About two years passed between the publication and the label change.
- Ophthalmology, 2018
- FDA review
- Elmiron label
Two years from the first study to the label warning.
Each date says what kind of date it is, and each entry is cited.
- Published2018A study in Ophthalmology describes the eye damage.Pearce et al., 2018
- Submitted24 June 2019The manufacturer proposes adding a warning.FDA review of the proposal
- Approved16 June 2020FDA approves; the label warns of retinal pigmentary changes.Elmiron label, June 2020
The original words, highlighted.
One click opens the label text beside the answer.
WARNINGS
Retinal Pigmentary Changes Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use.
The passage sits in the Warnings section of the label, under the run-in heading “Retinal Pigmentary Changes”. The study, FDA’s review and the label all sit behind the answer’s citations.
The same record answers other questions.
A pattern across a drug class. What FDA reviewed and decided. The law around it.
The Elmiron question is one use. Kelsey searches safety reports, label history, FDA decisions, studies and case law together, so the same record answers questions about a whole drug class, about FDA’s own reviews, and about the rulings around a drug.
Drugs, classes and portfolios can go on a watch list, with an alert and its source when new dated evidence appears.
Working product. Test links upon request.
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