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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "presentationDate": "2023-03-28 00:00:00",
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  "notes": "The slide presents a specific pharmacovigilance case report, highlighting a positive dechallenge.",
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      "text": "With a positive dechallenge, the events of psychiatric issues, aggression, and hallucinations are assessed as possibly related to WAKIX.",
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      "text": "On 07-OCT-2020, a spontaneous report was received from a physician regarding a female patient (age not reported) who was being treated with WAKIX (pitolisant). Medical history and concomitant medications were not reported. On an unspecified date, the patient started treatment with WAKIX for daytime sleepiness associated with narcolepsy. On an unreported date after starting WAKIX, the patient experienced \"psychiatric issues\" for which she was hospitalized. According to the reporter, the police were called since the patient became violent and was hallucinating. The patient was also COVID positive during this time. WAKIX was withdrawn. Following WAKIX discontinuation she was \"back to normal,\" presumed to mean psychiatric issues, violence, and hallucinations resolved. As of(b)(6)******, the patient's COVID status and the status of her hospitalization were not reported. No additional information was provided. Comment: A female patient was hospitalized for \"psychiatric issues,\" aggression and hallucinations while receiving WAKIX. The patient was also COVID positive during this time. After WAKIX was withdrawn, she recovered. With a positive dechallenge, the events of psychiatric issues, aggression, and hallucinations are assessed as possibly related to WAKIX. COVID positive test result is assessed as unrelated to WAKIX.",
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      "text": "A female patient of unknown age was “hospitalized for ‘psychiatric issues,’ aggression and hallucinations while receiving WAKIX.” According to the physician who submitted the report, “the police were called since the patient became violent and was hallucinating.” Pitolisant was withdrawn and the patient was “back to normal.” The patient was also COVID-positive. “With a positive dechallenge, the events of psychiatric issues, aggression, and hallucinations are assessed as possibly related to WAKIX.”",
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      "text": "“hospitalized for ‘psychiatric issues,’ aggression and hallucinations while receiving WAKIX.” — Physician report",
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      "text": "Source: FDA FAERS – FOIA Case Report Information",
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      "kind": "title",
      "text": "Case ID: 18410926, Event date: 2020",
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