{
 "query": "atropine / diphenoxylate",
 "ingredient": "atropine / diphenoxylate",
 "slug": "atropine-diphenoxylate",
 "rxcui": "594040",
 "brands": [
  "Lomotil"
 ],
 "names": [
  "atropine / diphenoxylate"
 ],
 "components": [
  {
   "ingredient": "atropine",
   "slug": "atropine",
   "grade": "C",
   "total": 74,
   "scores": {
    "safety": "C",
    "evidence": "D",
    "regulatory": "C",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "05/15/1973",
   "first_approval": "19730515"
  },
  {
   "ingredient": "diphenoxylate",
   "slug": "diphenoxylate",
   "grade": "B",
   "total": 78,
   "scores": {
    "safety": "A",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": true,
   "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": "19730515",
  "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": [
   "atropine / diphenoxylate",
   "Lomotil"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 741981,
  "beneficiaries": 311469,
  "spend": 15398523.92,
  "by_brand": [
   {
    "brand": "Diphenoxylate-Atropine",
    "claims": 741208,
    "per_claim": 20.441802369,
    "is_generic": false
   },
   {
    "brand": "Lomotil",
    "claims": 773,
    "per_claim": 319.40034929,
    "is_generic": false
   }
  ],
  "per_claim": 20.75325907267167
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 71,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, atropine (71)",
    "7,573 FDA reports naming it as the suspect drug per million Medicare fills, 2.7x the median drug on this site (-9)",
    "Death appears in 1.9x the share of reports seen across all of FAERS (-5)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 26,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, diphenoxylate (26)",
    "14 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 68,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, atropine (68)",
    "Recalls since 2016: 1 Class I, 3 Class II, 0 Class III across 19 generic makers (-24)",
    "6 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, atropine (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, atropine (100)",
    "Generic versions approved (19 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "This is a fixed combination of atropine and diphenoxylate. Why both together, instead of only the one I need?",
  "The most-reported problems in FDA's adverse event data are diarrhoea, nausea. 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 cyclopentolate, homatropine, hyoscyamine? 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.)",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are diarrhoea, nausea, fatigue. How would we recognize and handle those?",
  "Why this one over difenoxin, eluxadoline, loperamide? 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?"
 ]
}