{
 "query": "miconazole / polymyxin b / prednisolone",
 "ingredient": "miconazole / polymyxin b / prednisolone",
 "slug": "miconazole-polymyxin-b-prednisolone",
 "rxcui": "1008294",
 "brands": [],
 "names": [
  "miconazole / polymyxin b / prednisolone"
 ],
 "components": [
  {
   "ingredient": "miconazole",
   "slug": "miconazole",
   "grade": "B",
   "total": 82,
   "scores": {
    "safety": "A",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "01/08/1974",
   "first_approval": "19740108"
  },
  {
   "ingredient": "polymyxin b",
   "slug": "polymyxin-b",
   "grade": "B",
   "total": 77,
   "scores": {
    "safety": "B",
    "evidence": "F",
    "regulatory": "B",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "06/29/1964",
   "first_approval": "19640629"
  },
  {
   "ingredient": "prednisolone",
   "slug": "prednisolone",
   "grade": "B",
   "total": 85,
   "scores": {
    "safety": "B",
    "evidence": "C",
    "regulatory": "B",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "05/22/1955",
   "first_approval": "19550522"
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "19550522",
  "first_approval_fmt": "",
  "anda": 9,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "miconazole / polymyxin b / prednisolone"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, prednisolone (85)",
    "9,307 FDA reports naming it as the suspect drug per million Medicare fills, 3.4x the median drug on this site (-10)",
    "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 30,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, miconazole (30)",
    "94 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 30% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, prednisolone (84)",
    "Recalls since 2016: 0 Class I, 2 Class II, 1 Class III across 72 generic makers (-3)",
    "8 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": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, miconazole (100)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, miconazole (100)",
    "Generic versions approved (18 applications)",
    "50 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "C",
 "questions": [
  "This is a fixed combination of miconazole and polymyxin b and prednisolone. Why both together, instead of only the one I need?",
  "The most-reported problems in FDA's adverse event data are vulvovaginal burning sensation, vulvovaginal pain, vulvovaginal pruritus. How would we recognize and handle those?",
  "Why this one over acetic acid, aluminum acetotartrate, amphotericin b? What would make you pick one of those instead?",
  "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 pain, drug hypersensitivity, malaise. How would we recognize and handle those?",
  "Why this one over acetic acid, aluminum acetotartrate, amikacin? What would make you pick one of those instead?",
  "The most-reported problems in FDA's adverse event data are pyrexia, dyspnoea. 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 alclometasone, beclomethasone, betamethasone? What would make you pick one of those instead?"
 ]
}