North America – December 17, 2020 – Health Canada, a government agency responsible for Canada’s federal health policies, issued an “Important Safety Information” letter (RA-74549) warning healthcare providers about Elmiron (Pentosan Polysulfate Sodium) Pigmentary Maculopathy Risks. Health Canada announced two new updates concerning the “Canadian Product Monograph” for prescription drug Elmiron. The updates include a new contraindication as well as further information regarding the increased risk of pigmentary maculopathy. The letter was issued to Canadians, and all healthcare professionals, including urogynecologists, urologists, optometrists, ophthalmologists, pharmacists, and family physicians.
The Important Safety Information included the following key messages:
- Long-term use of Elmiron has been linked to the development of pigmentary maculopathy.
- Patients with a medical history of macular pathology should not be prescribed Elmiron.
- Healthcare professionals are urged to:
- Judge the benefits and risks before prescribing Elmiron to patients and make the assessment periodically.
- Collect comprehensive ophthalmologic history in all patients prior to initiating Elmiron treatments.
- Perform baseline retinal examinations and conduct regular retinal examinations to detect the early stages of pathology.
- Instruct patients to notify you of any vision changes, including slow adjustment to low or reduced light, difficulty reading, blurry vision, wavy vision near or in the center of their field of vision.
- Health Canada has updated the Canadian Product Monograph for Elmiron to incorporate a new contraindication and to extend the warnings about an increased risk of developing pigmentary maculopathy with long-term Elmiron use.
Elmiron (pentosan polysulfate sodium) is a glycosaminoglycan replacement therapy used to treat the initial and recurring symptoms of interstitial cystitis.
Health Canada is one of the first government agencies to affirm that long-term use of Elmiron increases the chance of developing pigmentary maculopathy. The visual symptoms of pigmentary maculopathy include blurred vision, slow adjustment to low or reduced light environments, and difficulty reading. These retinal and vision changes may be irreversible and may even progress even though the patient is no longer taking Elmiron.
Elmiron is now contraindicated in patients who have a medical history of macular pathologies. The Canadian Product Monograph for Elmiron has been updated to include the new contraindication and pigmentary maculopathy risks on the “Serious Warnings and Precautions Box” and the “Consumer Information” section.
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