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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2023-03-28 00:00:00",
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  "notes": "This is a pharmacovigilance case report summary.",
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      "text": "Given the known risk of psychiatric events including bipolar disorder and depression, an association with WAKIX cannot be ruled out.",
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      "text": "Event/Problem Narrative:\nOn 30-JUL-2020, a spontaneous report was received from a nurse practitioner via a company representative regarding a female in her mid-30s who was being treated with WAKIX (pitolisant). Medical history and concomitant products were not reported. On an unreported date, the patient started treatment with WAKIX for an unreported indication. On an unspecified date, the patient showed signs of psychosis. As of 30-JUL-2020, the status of treatment with WAKIX and outcome of signs of psychosis were not reported. No additional information was provided. Comment: A female patient in her mid-30s treated with WAKIX (pitolisant) for an unknown duration and indication showed signs of psychosis, not further described. Lack of further information, including medical history, psychiatric history, concomitant medications, treatment duration, and event details, precludes a complete assessment. Given the known risk of psychiatric events including bipolar disorder and depression, an association with WAKIX cannot be ruled out. Follow-up information is being pursued.",
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      "text": "A female patient in her mid-30's who was being treated with an unknown dose of pitolisant “showed signs of psychosis.” No information was provided as to hospitalization, outcome, time to onset after starting pitolisant. “Given the known risk of psychiatric events including bipolar disorder and depression, an association with WAKIX cannot be ruled out. Follow-up information is being pursued.”",
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      "kind": "quote",
      "text": "A female patient in her mid-30’s who was being treated with an unknown dose of pitolisant “showed signs of psychosis.” — FDA FAERS Case Report",
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      "text": "Source: FDA FAERS – FOIA Case Report Information",
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      "kind": "title",
      "text": "Case ID: 18135725, Event date: 2020 (unclear)",
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