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Latest revision as of 08:26, 13 November 2025


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Young additionally observed customer complaints just like those found through the 2011 inspection: arrhythmia, chest pain, headaches, dizziness, tingling, allergic reactions, high blood strain, hallucinations, psychological decline, blood sugar issues, sleeping issues, and vision problems. During dialogue of the inspection with Quincy management, she wrote, "I acknowledged these aren't typical complaints related to supplements. Two additional inside critiques by the FDA that year would also elevate considerations concerning the patterns of complaints associated with Prevagen. Shortly after Young finished her in-person inspection, the center for Drug Evaluation and Research’s Office of Surveillance and Epidemiology carried out an summary of Prevagen circumstances within the adverse reporting system for medicine. The abbreviated review, dated March 19 and obtained via FOIA, covers eight cases, together with stories of elevated dizziness and loss of steadiness that resulted in damage. "Despite the fact that the vast majority of instances would not have medical affirmation, they provide a sample of events that are temporal with the administration of Prevagen, some of which resolved with discontinuation of Prevagen," the medical reviewer wrote.