{
 "query": "phentermine / topiramate",
 "ingredient": "phentermine / topiramate",
 "slug": "phentermine-topiramate",
 "rxcui": "1302826",
 "brands": [
  "Qsymia"
 ],
 "names": [
  "phentermine / topiramate"
 ],
 "components": [
  {
   "ingredient": "phentermine",
   "slug": "phentermine",
   "grade": "B",
   "total": 80,
   "scores": {
    "safety": "A",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": true,
   "first_approval_fmt": "08/14/1973",
   "first_approval": "19730814"
  },
  {
   "ingredient": "topiramate",
   "slug": "topiramate",
   "grade": "B",
   "total": 81,
   "scores": {
    "safety": "B",
    "evidence": "C",
    "regulatory": "B",
    "conflict": "A",
    "options": "C"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "12/24/1996",
   "first_approval": "19961224"
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "19730814",
  "first_approval_fmt": "",
  "anda": 51,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 143971.94,
  "records": 2228,
  "by_name": [
   [
    "Qsymia",
    143971.94
   ]
  ],
  "names_checked": [
   "phentermine / topiramate",
   "Qsymia"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 84,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, topiramate (84)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)",
    "4,040 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (0.8x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 35,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, phentermine (35)",
    "35 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, topiramate (86)",
    "Recalls since 2016: 0 Class I, 0 Class II, 2 Class III across 51 generic makers (-1)",
    "25 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": 85,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, phentermine (100)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL",
    "For the combination product itself:",
    "Pharma paid doctors $143,972 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, topiramate (70)",
    "Generic versions approved (51 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 71,
 "grade": "C",
 "questions": [
  "This is a fixed combination of phentermine and topiramate. Why both together, instead of only the one I need?",
  "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 nausea, fatigue, pain. How would we recognize and handle those?",
  "Why this one over cathine, clobenzorex, dexfenfluramine? 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.)",
  "In 2011 the FDA issued a safety communication about this drug (Topamax - Risk of oral clefts in children born to mothers taking Topamax (topiramate)). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are headache, 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?"
 ]
}