{
 "query": "fluticasone / vilanterol",
 "ingredient": "fluticasone / vilanterol",
 "slug": "fluticasone-vilanterol",
 "rxcui": "1424888",
 "brands": [
  "Breo"
 ],
 "names": [
  "fluticasone / vilanterol"
 ],
 "components": [
  {
   "ingredient": "fluticasone",
   "slug": "fluticasone",
   "grade": "B",
   "total": 83,
   "scores": {
    "safety": "A",
    "evidence": "B",
    "regulatory": "B",
    "conflict": "F",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "12/14/1990",
   "first_approval": "19901214"
  },
  {
   "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": "19901214",
  "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": [
   "fluticasone / vilanterol",
   "Breo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2789395,
  "beneficiaries": 704534,
  "spend": 1427586472.25,
  "by_brand": [
   {
    "brand": "Breo Ellipta",
    "claims": 2617269,
    "per_claim": 519.8275915,
    "is_generic": false
   },
   {
    "brand": "Fluticasone-Vilanterol",
    "claims": 172126,
    "per_claim": 389.58572005,
    "is_generic": false
   }
  ],
  "per_claim": 511.79071886556045
 },
 "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": 63,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, vilanterol (63)",
    "106 randomized trials and 15 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": 86,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, fluticasone (86)",
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 25 generic makers (-1)",
    "17 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 35,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, fluticasone (35)",
    "Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)",
    "Pharma paid doctors $1,294,173 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, vilanterol (40)",
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "This is a fixed combination of fluticasone and vilanterol. Why both together, instead of only the one I need?",
  "The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, headache. 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?",
  "Why this one over amcinonide, beclomethasone, betamethasone? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?"
 ]
}