{
 "query": "fluticasone / salmeterol",
 "ingredient": "fluticasone / salmeterol",
 "slug": "fluticasone-salmeterol",
 "rxcui": "284635",
 "brands": [
  "Advair",
  "AirDuo",
  "Wixela"
 ],
 "names": [
  "fluticasone / salmeterol"
 ],
 "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": "salmeterol",
   "slug": "salmeterol",
   "grade": "B",
   "total": 80,
   "scores": {
    "safety": "C",
    "evidence": "B",
    "regulatory": "A",
    "conflict": "A",
    "options": "C"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "02/04/1994",
   "first_approval": "19940204"
  }
 ],
 "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 / salmeterol",
   "Advair",
   "AirDuo",
   "Wixela"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2012,
   "company": "GlaxoSmithKline",
   "amount_usd": 3000000000.0,
   "amount_text": "$3 billion ($1B criminal, $2B civil)",
   "violations": "Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program",
   "products": "Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2012/July/12-civ-842.html",
    "https://web.archive.org/web/20240714112314/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report"
   ],
   "matched": "advair"
  }
 ],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, salmeterol (70)",
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, salmeterol (75)",
    "580 randomized trials and 44 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist",
    "Only 46% of completed registered trials posted results (-8)"
   ],
   "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",
    "For the combination product itself:",
    "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 $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, salmeterol (70)",
    "No generic version approved: brand-only pricing (-30)",
    "15 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 68,
 "grade": "C",
 "questions": [
  "This is a fixed combination of fluticasone and salmeterol. 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.)",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma, cough. How would we recognize and handle those?",
  "Why this one over albuterol, bitolterol, clenbuterol? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?"
 ]
}