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Clinical studies have begun to illuminate the relationship between semaglutide and blood pressure, with data suggesting that semaglutide can lead to improvements in blood pressure readings

The firms own SOP states that OOS results must be immediately reported to Quality and the pharmacist-in-charge, and that investigation, root cause analysis, recall, and customer notification procedures shall be followed when applicable. The FDA pointedly notes that the when applicable language effectively makes investigation and notification optional rather than mandatory

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"If NAION is confirmed, treatment with semaglutide should be stopped." EMAs regulatory action stems from mounting scientific evidence, including groundbreaking research published in JAMA, along with multiple large-scale epidemiological studies showing a higher risk of NAION in patients prescribed semaglutide compared with patients prescribed other medications for diabetes or obesity