{
 "query": "fenfluramine",
 "ingredient": "fenfluramine",
 "slug": "fenfluramine",
 "rxcui": "4328",
 "brands": [
  "Fintepla"
 ],
 "names": [
  "fenfluramine",
  "fenfluramine hydrochloride"
 ],
 "classes": [
  {
   "id": "A08AA",
   "name": "Centrally acting antiobesity products"
  }
 ],
 "alternatives": [
  "cathine",
  "clobenzorex",
  "dexfenfluramine",
  "diethylpropion",
  "lorcaserin",
  "mazindol",
  "mefenorex",
  "phentermine",
  "setmelanotide",
  "sibutramine"
 ],
 "label": {},
 "faers": {
  "total": 5549,
  "serious": 4551,
  "death": 129,
  "hospitalization": 1556,
  "primary_suspect": 5523,
  "top_reactions": [
   [
    "Seizure",
    2251
   ],
   [
    "Drug Ineffective",
    822
   ],
   [
    "Off Label Use",
    812
   ],
   [
    "Tricuspid Valve Incompetence",
    720
   ],
   [
    "Decreased Appetite",
    645
   ],
   [
    "Somnolence",
    544
   ],
   [
    "Weight Decreased",
    488
   ],
   [
    "Mitral Valve Incompetence",
    420
   ],
   [
    "Diarrhoea",
    362
   ],
   [
    "Fatigue",
    354
   ],
   [
    "Generalised Tonic-Clonic Seizure",
    323
   ],
   [
    "Pneumonia",
    264
   ],
   [
    "Pulmonary Valve Incompetence",
    260
   ],
   [
    "Hospitalisation",
    246
   ],
   [
    "Epilepsy",
    241
   ]
  ],
  "by_year": {
   "2019": 11,
   "2020": 45,
   "2021": 453,
   "2022": 813,
   "2023": 690,
   "2024": 1098,
   "2025": 1663,
   "2026": 756
  },
  "by_year_primary": {
   "2019": 11,
   "2020": 45,
   "2021": 451,
   "2022": 807,
   "2023": 687,
   "2024": 1093,
   "2025": 1655,
   "2026": 754
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 2,
  "nda": 1,
  "anda": 0,
  "first_approval": "20200625",
  "rems": true,
  "rems_last": "20260522",
  "labeling_supplements": 7,
  "labeling_recent": 7,
  "sponsors": [
   "APOTEX INC",
   "UCB INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/25/2020"
 },
 "trials": {
  "total": 30,
  "completed": 16,
  "terminated": 4,
  "with_results": 10,
  "industry": 20,
  "phase3": 12,
  "results_share": 0.625,
  "terminated_share": 0.13333333333333333
 },
 "pubmed": {
  "rct": 123,
  "meta": 11,
  "recent_rct": 10,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 1075592.16,
  "records": 8633,
  "by_name": [
   [
    "Fintepla",
    1075592.16
   ]
  ],
  "names_checked": [
   "fenfluramine",
   "Fintepla"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2456,
  "beneficiaries": 292,
  "spend": 40885327.13,
  "by_brand": [
   {
    "brand": "Fintepla",
    "claims": 2456,
    "per_claim": 16647.120167,
    "is_generic": false
   }
  ],
  "per_claim": 16647.12016693811
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Infectious diseases",
  "names": [
   "fenfluramine"
  ],
  "reason": "Fenfluramine is an amphetamine authorised as an add-on to antiepileptic therapy in Dravet syndrome and Lennox-Gastaut syndrome, two rare and serious forms of infantile epilepsy. Despite a decrease in the overall frequency of seizures, fenfluramine appears to increase the incidence of convulsive status epilepticus. Fenfluramine can provoke heart valve disease and pulmonary arterial hypertension, which is why its use as an appetite suppressant was discontinued. It can also cause neuropsychiatric disorders and other cardiovascular disorders (Prescrire Int n\u00b0 233, 263).",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "fenfluramine"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 75,
   "letter": "B",
   "why": [
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "Death share in reports is near or below the FAERS average (0.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 48,
   "letter": "F",
   "why": [
    "123 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 82,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "REMS program in force (-10)",
    "7 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,075,592 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 68,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are seizure, tricuspid valve incompetence. 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 cathine, clobenzorex, dexfenfluramine? 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?",
  "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.)"
 ]
}