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  "documentTitle": "Harmony Biosciences (HRMY)",
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      "text": "the FDA stated that “based on a temporal association, a contributory role of WAKIX cannot be ruled out.”",
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      "text": "A 45-year old female was diagnosed with hepatic cytolysis 20 days after starting pitolisant. Lab tests for viral causes were negative, suggesting it may be drug-induced. The report notes the lack of info regarding dose, baseline hepatic function, clinical course, or outcome. Nor does it state if the patient was hospitalized. The patient had a complex medical history including “chronic kidney failure,” dialysis, diabetes, pancreatic failure, and narcolepsy. The pitolisant label suggests 17.8mg daily for patients with moderate or severe renal impairment, although the full prescribing information contains a PK chart that shows 5-fold higher plasma levels in patients with severe impairment at the 90% confidence interval. The patient’s medical history is hardly unusual for narcolepsy patients who present with myriad comorbidities such as obesity, diabetes, cardiovascular history, etc. The report notes that the physician thought it was unrelated to pitolisant and continued treatment, while the FDA stated that “based on a temporal association, a contributory role of WAKIX cannot be ruled out.”",
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      "text": "“based on a temporal association, a contributory role of WAKIX cannot be ruled out.” — FDA",
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      "text": "Source: FDA FAERS – FOIA Case Report Information",
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      "kind": "title",
      "text": "Case ID: 21323707, Event date: May 2022",
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