{ "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": 199, "pageCount": 366, "prevPage": 198, "nextPage": 200, "slideType": "other", "function": "illustrate_case", "density": "dense", "nDataPoints": 0, "notes": "This is a clinical case study/adverse event report sourced from FDA FAERS data.", "elementsJson": [ "headline_text", "paragraph", "footnote" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/199", "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-199", "components": [ { "bbox": null, "kind": "callout", "text": "In the absence of alternative etiologies, an association with Wakix is possible.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-64d1-73a9-abb6-ab69e328b3a0", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.45, "w": 0.86, "x": 0.07, "y": 0.48 }, "kind": "paragraph", "text": "Event/Problem Narrative: On 09-MAR-2020, a spontaneous report was received from a consumer, via a company representative (Case ID: 030920-R112068), regarding a 36-year-old female who was being treated with WAKIX (pitolisant). On 13-MAR-2020, additional information was received from a consumer via a company representative (Case ID: 031320-R112068) and the case was re-assessed as serious and unexpected. On 06-MAY-2022, the Report Type for this case is being revised from spontaneous to solicited since the initial case information originated from a company-sponsored patient support program. This case has been assessed as serious, unexpected, and possibly related to WAKIX. Medical history included bipolar disorder, an underlying connective tissue disorder, and migraines. Concomitant products were not reported. On 03-MAR-2020, the patient started treatment with WAKIX. The doses, route(s) and frequencies of administration, and indication(s) of usage were not reported. On an unspecified date(s) in MAR-2020, after starting the product, the patient experienced major anxiety, problems with her mood, mania, musculoskeletal pain, and joint pain. Additionally, since starting therapy, the patient noticed an increase in the severity of her migraines. On an unspecified date in (b)(6)** (\"recently\" relative to (b)(6)*****), the patient started having an anaphylactic reaction. The symptoms were described as swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and she lost her voice. The patient went to urgent care and was given epinephrine and steroids for the reaction. An ambulance then transported her to the ER (emergency room). The patient was treated in the ER and a D-dimer test was completed to check for pulmonary embolisms. The results showed an increase in the D-dimer test. Treatment with WAKIX was discontinued on 07-MAR-2020. As of(b)(6)******, the events of anxiety, mania, joint pain, increased migraine severity, and anaphylactic reaction (including swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and loss of voice) were resolved. The current status of problems with mood and musculoskeletal pain were unknown. No further information could be obtained, as the contact information for the reporter was not provided. Comment: An unknown time (within days) after the start of WAKIX, a 36-year-old female had an anaphylactic reaction with symptoms described as swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and losing her voice. She recovered after treatment with epinephrine, steroids, and unspecified medications in the emergency room. Treatment with WAKIX was discontinued on 07-MAR-2020 and the events had resolved. In the absence of alternative etiologies, an association with WAKIX is possible.", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "c352e896-13f4-47fb-befb-222562803409", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.25, "w": 0.86, "x": 0.07, "y": 0.11 }, "kind": "paragraph", "text": "A few days after starting pitolisant (started treatment on Mar 3,2020 and discontinued on Mar 7, suggesting the event occurred in between), a 36-year old female patient experienced mania, migraines, and an anaphylactic reaction “described as swelling and burning of the lips, itching, tongue swelling, chest pain, wheezing, and lost her voice. Patient went to urgent care and was taken by ambulance to an ER. D-dimer test was conducted to check for pulmonary embolism, and “results showed an increase in D-dimer test.” Pitolisant was discontinued and the patient recovered after treatment in the ER with epinephrine and steroids. “In the absence of alternative etiologies, an association with Wakix is possible.”", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "d8763ff1-49ee-404e-97ee-ea9b7d9ca8d0", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "In the absence of alternative etiologies, an association with Wakix is possible. — FDA FAERS Case Report", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-64d1-73a9-abb6-aeebfdd7aaf1", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.25, "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": "4c7d34bd-401a-4561-9d42-f7fc7b75c354", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.03, "w": 0.45, "x": 0.07, "y": 0.07 }, "kind": "title", "text": "Case ID: 17585737, Event date: 2020", "attrs": null, "subkind": "headline", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "2ad4eab6-2307-46f8-a688-32d7e99ae540", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }