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elmiron [2020/08/24 00:47] – created Scott Larsonelmiron [2025/04/18 20:40] (current) – external edit 127.0.0.1
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 The purpose of this letter is to inform you of an important safety update relating to ELMIRON® capsules, which is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis (IC).1 The purpose of this letter is to inform you of an important safety update relating to ELMIRON® capsules, which is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis (IC).1
  
-A new WARNING for pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, has been added to the ELMIRON® United States Prescribing Information (USPI) June 2020.1+A new WARNING for **pigmentary changes in the retina**, reported in the literature as **pigmentary maculopathy**, has been added to the ELMIRON® United States Prescribing Information (USPI) June 2020.1
  
-Cases of pigmentary changes have been reported 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. These changes may be irreversible, and retinal and vision changes may progress even after cessation of therapy.2-5+Cases of pigmentary changes have been reported 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**. These **changes may be irreversible**, and retinal and **vision changes may progress even after cessation of therapy**.2-5
  
 The ELMIRON® USPI is being updated to include a new WARNING for Retinal Pigmentary Changes (included below) and to add additional information about retinal pigmentary changes in the PRECAUTIONS, Information for Patients, and Post-Marketing Experience Adverse Reactions sections. The ELMIRON® USPI is being updated to include a new WARNING for Retinal Pigmentary Changes (included below) and to add additional information about retinal pigmentary changes in the PRECAUTIONS, Information for Patients, and Post-Marketing Experience Adverse Reactions sections.