{
  "id": "ARXO-2026-0323",
  "url": "https://arxo.io/findings/ARXO-2026-0323/",
  "record_kind": "discrepancy",
  "class": "act_text",
  "class_label": "Text of the act",
  "jurisdiction": "US",
  "jurisdiction_detail": "federal",
  "act": "pralsetinib prescribing information (SPL set ID 16edd46e-28b8-f06d-e063-6394a90ae31b)",
  "acts": [
    "FDA prescribing information published on DailyMed"
  ],
  "location": "Highlights, Warnings and Precautions",
  "text": {
    "en": {
      "title": "pralsetinib: Highlights, Warnings and Precautions has no instruction for a patient the label covers",
      "summary": "Highlights, Warnings and Precautions reads “Permanently discontinue for Grade 3 or 4 reactions”. Example: Grade 3 ILD or pneumonitis: Highlights requires permanent discontinuation; Table 2 has ILD rows only for Grade 1 or 2 and Grade 4, so it gives no action for Grade 3, and the general row for other adverse reactions allows resumption at a reduced dose. The text is in this label.",
      "impact": "Potential effect on a prescribing decision: medium. Arxo does not say which instruction is correct and gives no dose."
    }
  },
  "status": {
    "badge": "reported",
    "label": {
      "en": "Reported",
      "ru": "Сообщено"
    },
    "conclusion": "confirmed",
    "official_text": "unchanged",
    "addressee": "none",
    "last_checked": "2026-10-31",
    "fixed_on": null,
    "correction_type": null,
    "under_review": false
  },
  "origin": "The text of the act",
  "evidence": {
    "method": "Reproduced by execution",
    "quotes": [
      {
        "location": "q1",
        "source": "Prescribing information, Rigel Pharmaceuticals, Inc., SPL set ID 16edd46e-28b8-f06d-e063-6394a90ae31b, version 8 (DailyMed)",
        "role": "Official publication",
        "language": "en",
        "edition": "version 8",
        "locator": "Highlights, Warnings and Precautions",
        "text": "Permanently discontinue for Grade 3 or 4 reactions",
        "translations": {},
        "url": "https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/16edd46e-28b8-f06d-e063-6394a90ae31b.xml",
        "sha256": "a49c8c2828cc648d665007781d893be175b05ca8c23ad0cf8989212cb689b19f",
        "retrieved": "2026-10-29",
        "copy": "sources/a49c8c2828cc648d-16edd46e-28b8-f06d-e063-6394a90ae31b-v8.xml",
        "copy_sha256": "a49c8c2828cc648d665007781d893be175b05ca8c23ad0cf8989212cb689b19f",
        "copy_kind": "copy of the official file"
      }
    ]
  },
  "impact_shown": false,
  "notified": [
    {
      "date": "2026-10-31",
      "institution": "Rigel Pharmaceuticals, Inc.",
      "channel": "email",
      "role": "holder of the labeling"
    },
    {
      "date": "2026-10-31",
      "institution": "U.S. Food and Drug Administration, Center for Drug Evaluation and Research",
      "channel": "email",
      "role": "regulator of prescription drug labeling"
    }
  ],
  "responsible": [
    {
      "institution": "Rigel Pharmaceuticals, Inc.",
      "role": "holder of the labeling"
    },
    {
      "institution": "U.S. Food and Drug Administration, Center for Drug Evaluation and Research",
      "role": "regulator of prescription drug labeling"
    }
  ],
  "responses": [],
  "approval": "2026-10-31",
  "ai_role": {
    "en": "AI agents read the labels, compared their parts and, where marked, ran the example patient through executable rules; an AI agent then read each place in full, with tables and footnotes, and confirmed it. No clinician has assessed these places. A person at Arxo approved publication (2026-10-31)."
  },
  "credit": [],
  "press_date": null,
  "earlier_publications": [],
  "reproduction": [],
  "sources": [],
  "related": [],
  "first_published": null,
  "history": [
    {
      "date": "2026-10-31",
      "event": "confirmed",
      "text": "Confirmed by Arxo"
    },
    {
      "date": "2026-10-31",
      "event": "reported",
      "text": "Reported to Rigel Pharmaceuticals, Inc. (e-mail)"
    },
    {
      "date": "2026-10-31",
      "event": "reported",
      "text": "Reported to U.S. Food and Drug Administration, Center for Drug Evaluation and Research (e-mail)"
    }
  ]
}