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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Scorpion Capital",
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      "text": "The report noted that \"with a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.\"",
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      "text": "Event/Problem Narrative: On 11-JUN-2020, a spontaneous report was received from a nurse practitioner via a company representative regarding a 45-year-old male who was being treated with WAKIX (pitolisant). On 20-JUL-2020, additional information was received from a nurse practitioner. Medical history included bipolar disorder, depression, anxiety, and visits to the psychiatric ED (emergency department; last in 2017). Concomitant products were not reported. On an unspecified date in 2020 (reported as (b)(6)************ relative to (b)(6)*****), the patient started treatment with WAKIX for narcolepsy. On(b)(6)******, around the time WAKIX was titrated to the maximum dose of 35.6 mg once daily (also reported as \"when he got up to the full dose\"), the patient had a manic episode and went to a psychiatric hospital ER (emergency department), and required inpatient hospitalization for approximately (b)(6) weeks. While hospitalized, the patient was diagnosed with paranoid schizophrenia and was started on Latuda (lurasidone hydrochloride). The patient also felt sad, was screaming, very aggressive, and said he felt like he was God. On an unspecified date (reported as \"recently\" relative to(b)(6)******), the patient was discharged to home. The patient was taken off WAKIX and subsequently felt \"fine\" which was presumed to mean manic episode, aggression, screaming, and sad feeling were resolved. As of 11-JUN-2020, the event of paranoid schizophrenia was ongoing. No additional information was provided. On 20-JUL-2020, the nurse practitioner reported that the patient was Caucasian and that there was a big lag time between when she prescribed the product and when the patient started it. No additional information was provided. Comment: A 45-year-old male, with a history of bipolar disorder, treated with WAKIX for narcolepsy, experienced a manic episode requiring inpatient hospitalization. While hospitalized, he was diagnosed with paranoid schizophrenia. WAKIX was discontinued, and subsequently he felt \"fine.\" Paranoid schizophrenia was ongoing. With a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.",
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      "text": "A 45-year old male patient, “around the time WAKIX was titrated to the maximum dose of 35.6 mg once daily (also reported as \"when he got up to the full dose\"), the patient had a manic episode and went to a psychiatric hospital ER (emergency room), and required inpatient hospitalization for approximately (b)(6) weeks.” The patient also “felt sad, was screaming, very aggressive, and said he felt like he was God.” Patient was also diagnosed with paranoid schizophrenia while in the hospital. Pitolisant was discontinued and the patient “subsequently felt ‘fine’ which was presumed to mean manic episode, aggression, screaming, and sad feeling were resolved.” The report noted that “with a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.”",
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      "kind": "quote",
      "text": "\"with a positive dechallenge, a causal association with WAKIX for the events cannot be ruled out.\" — 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: 17930672, Event date: 2020",
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