{ "docId": "019dd923-622c-750b-8b9a-21918ac10c17", "docSlug": "f3db2294dcf9", "documentTitle": "Harmony Biosciences (HRMY)", "authorId": "58_Scorpion_Capital", "authorName": "Scorpion Capital", "documentKindSlug": "research-note", "documentKindLabel": "Research note", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2023-03-28 00:00:00", "orientation": "landscape", "aspectRatio": 1.3333334, "pageNumber": 200, "pageCount": 366, "prevPage": 199, "nextPage": 201, "slideType": "other", "function": "illustrate_case", "density": "dense", "nDataPoints": 0, "notes": "This is a pharmacovigilance case report summary.", "elementsJson": [ "headline_text", "paragraph", "footnote" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/200", "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-200", "components": [ { "bbox": null, "kind": "callout", "text": "Based on the temporal association between event onset and the start of WAKIX, and as the primary inciting events of anxiety and depression are labeled, the subsequent mental health issues and associated dyspnea are assessed as possibly related to WAKIX, which was ongoing as of last report.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-70f3-714d-84c6-4229e31dba89", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.41 }, "kind": "paragraph", "text": "On 04-MAY-2020, a solicited report was received from a consumer via a company representative (Case ID: 050420-R114980) regarding a 48-year-old female who was being treated with WAKIX (pitolisant). On 19-MAY-2020, additional information was received from a consumer via a company representative (Case ID: 051920-R114980) and based on the information received the case was reassessed as serious, unexpected, and possibly related to WAKIX. On 01-JUN-2020, additional information was received from a consumer via a company representative (060120-R114980). Medical history and concomitant products were not reported. On 30-APR-2020, the patient started treatment with WAKIX for an unreported indication. On 04-MAY-2020, after starting the product, the patient's MD (presumed to mean medical doctor) felt she had depression and or anxiety, but she did not yet have a confirmed diagnosis. The MD was going to be prescribing a new medication for the anxiety and depression, but the patient was not sure which medication they would prescribe as it depended on her ultimate diagnosis. On (b)(6)*****, it was learned from the patient that she had been hospitalized for \"mental health issues\" and had not taken the product since 11-MAY-2020. She was restarting the product \"now\" (relative to 19-MAY-2020). Since her hospitalization, the patient was newly prescribed Vistaril (hydroxyzine pamoate), Toprol XL (metoprolol succinate), and trazodone (routes, doses, frequencies and indications for use were not reported). As of 04-MAY-2020, the statuses of the patient's anxiety and depression were both unknown and as of 19-MAY-2020, the status of the patient's mental health issues was not reported. No additional information is expected, as contact information for the consumer was not provided. On 01-JUN-2020, the status treatment with WAKIX and outcomes of extreme leg swelling, difficulty catching her breath, and anxiety were ongoing. No additional information is expected, as contact information for the consumer was not provided. Comment: A 48-year-old female, treated with WAKIX since 30-APR-2020, was hospitalized for mental health issues with depression and/or anxiety since 04-MAY-2020, and had not taken the product since 11-MAY-2020. She was newly prescribed Vistaril, Toprol XL, and trazodone, and the outcome was not reported. More recently reported events include transient lower extremity swelling and difficulty catching her breath which was possibly related to anxiety, all of which were ongoing. Based on the temporal association between event onset and the start of WAKIX, and as the primary inciting events of anxiety and depression are labeled, the subsequent mental health issues and associated dyspnea are assessed as possibly related to WAKIX, which was ongoing as of last report. Peripheral edema is confounded by trazodone and Toprol XL, for which edema and peripheral edema are labeled, respectively and unlikely related to WAKIX.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "2c4953e4-1867-47f0-92d0-05023528757d", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.15, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A 48-year old female patient was hospitalized for mental health issues with depression and/or anxiety, five days after starting pitolisant. Patient also reported “difficulty catching her breath” (dyspnea) and peripheral edema. “Based on the temporal association between event onset and the start of WAKIX, and as the primary inciting events of anxiety and depression are labeled, the subsequent mental health issues and associated dyspnea are assessed as possibly related to WAKIX, which was ongoing as of last report.”", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d709dbba-074b-47e1-acb8-3cffef20dc47", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.3, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: FDA FAERS – FOIA Case Report Information", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "6791a41f-179f-4bcf-9ef9-d6be7e533bd7", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "w": 0.5, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 17849858, Event date: 2020 (unclear)", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "eb9554bd-f69a-469c-8b71-cadf1fa88860", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.2, "x": 0.07, "y": 0.38 }, "kind": "title", "text": "Event/Problem Narrative:", "attrs": null, "subkind": "subtitle", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "3122ba46-0fb5-4bb8-b7ca-2271da26c795", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }