Table 3

Evidence supporting withdrawal, revocation or suspension

INN (n=18)Case reportAnimalObservationalCase-controlCohortCross-sectionalRCTMeta-analysis/
Systematic review
In vitro/in silico/ex vivoNon-placebo controlledNon-randomised/open label or non-blinded/non-comparativeOtherOther (epidemiological)
Meprobamate X X XX
Calcitonin X X X X XX X
Tolperisone X X X X X X X
Nicotinic acid/laropiprantXXX X XXXX X X
Tetrazepam X X X
Almitrine X XXX X XX X X
Cyproterone acetate/ethinylestradiol X X XX X X X X X
Hydroxyethyl starch intravenous infusionXXX X X X
Ergot derivatives X X X XX X XX X X X X
Ketoconazole X X X X X X X XX
Numeta G13%E X X X X
Metoclopramide X XX X X X X X X X
Ephedrine hydrochloride, lidocaine and arsenous anhydride X X X X X X X
Methadone containing high molecular weight povidone X X X X X X X
Domperidone X X X X X X X XX
Codeine monohydrate X
Codeine phosphate X X X XX X X X
Fusafungine X X X X X
N1 (%)17 (94.4%)13 (72.2%)8 (44.4%)6 (33.3%)10 (55.6%)2 (11.1%)13 (72.2%)13 (72.2%)13 (72.2%)9 (50.0%)12 (66.7%)6 (33.3%)4 (22.2%)
N2 (%) cited by regulatory agency, of total actions16 (88.9%)7 (38.9%)4 (22.2%)2 (11.1%)3 (16.7%)2 (11.1%)12 (66.7%)9 (50.0%)5 (27.8%)7 (38.9%)7 (38.9%)4 (22.2%)1 (5.6%)
  • X’ denotes evidence cited by regulatory agencies +/– in scientific literature; ‘X’ denotes evidence sourced solely from the published scientific literature.

  • INN, International Non-proprietary Name; RCT, randomised controlled trial.