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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Kir Kahlon",
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  "presentationDate": "2023-04-03 00:00:00",
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  "notes": "The slide uses a comparative historical analogy (Seldane) to frame the current safety concerns as a 'tragedy in the making'.",
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      "text": "Petitioner's analysis indicates that the post-marketing safety signal from Wakix, particularly with regard to cardiotoxicity, is exponentially worse than that which led to terfenadine's recall.",
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      "text": "An unreported case of drug-induced arrhythmia and hospitalization, which occurred in January 2022, that Petitioner obtained during an hour-long research interview with a physician.",
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      "text": "A case narrative obtained via FOIA (Case ID 21248927) of a 70-year old male who experienced a fatal heart attack in July 2022, two weeks after starting Wakix.",
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      "text": "Petitioner believes that Wakix is a regrettable repeat of the Seldane (terfenadine) saga... Petitioner's analysis indicates that the post-marketing safety signal from Wakix, particularly with regard to cardiotoxicity, is exponentially worse.",
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      "kind": "paragraph",
      "text": "The case deserves the utmost scrutiny for two reasons: 1) Petitioner only interviewed 16 Wakix prescribers, and to so easily find a near-fatality within a small sample (n=16) is an alarming safety signal...",
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      "text": "Wakix has been prescribed to a very small number of patients... Petitioner's report documents sales/marketing practices and prescribing behavior suggestive of recklessness and complacency.",
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      "text": "One individual report can make a difference. Many drug withdrawals began with one clinical report that initiated further investigation.",
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      "text": "One individual report can make a difference. Many drug withdrawals began with one clinical report that initiated further investigation. In the example case in this module, a single report ultimately led to the removal of terfenadine from the market. This report potentially saved many lives and led to a better understanding of the mechanism involved in causing torsades de pointes. Almost all drugs are now evaluated prior to being released on the market for their potential to induce cardiac arrhythmias, also as a result of this single case report. — FDA.gov Adverse Drug Reaction module",
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