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Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy.
Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathy
Cases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses.
Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions
Prescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
Letters and drug alerts sent to healthcare professionals in August 2019
A letter was sent to advise healthcare professionals about a restriction to the indication and route of administration for Mitomycin-C Kyowa 40 mg following the observation of increased sub-visible particles in the drug products.
Medical Devices Alerts issued in August 2019
An alert was issued advising against use of Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for Dermapen 3 since their safety cannot be verified.