{
 "query": "umeclidinium / vilanterol",
 "ingredient": "umeclidinium / vilanterol",
 "slug": "umeclidinium-vilanterol",
 "rxcui": "1487518",
 "brands": [
  "Anoro"
 ],
 "names": [
  "umeclidinium / vilanterol"
 ],
 "components": [
  {
   "ingredient": "umeclidinium",
   "slug": "umeclidinium",
   "grade": "B",
   "total": 84,
   "scores": {
    "safety": "A",
    "evidence": "D",
    "regulatory": "A",
    "conflict": "A",
    "options": "F"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "04/30/2014",
   "first_approval": "20140430"
  },
  {
   "ingredient": "vilanterol",
   "slug": "vilanterol",
   "grade": "B",
   "total": 79,
   "scores": {
    "safety": "B",
    "evidence": "C",
    "regulatory": "A",
    "conflict": "A",
    "options": "F"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "",
   "first_approval": ""
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "20140430",
  "first_approval_fmt": "",
  "anda": 0,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "umeclidinium / vilanterol",
   "Anoro"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 83,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, vilanterol (83)",
    "Death appears in 3.7x the share of reports seen across all of FAERS (-12)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "Graded by its riskiest ingredient, umeclidinium (59)",
    "63 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, umeclidinium (100)",
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, umeclidinium (100)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, umeclidinium (40)",
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "This is a fixed combination of umeclidinium and vilanterol. Why both together, instead of only the one I need?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma, wheezing, cough. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)",
  "The most-reported problems in FDA's adverse event data are abdominal pain, dyspnoea, constipation. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?"
 ]
}