Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: a cross-sectional study

Table 7 Essential medicines for children unapproved in the US, UK, and Japan with supporting evidence in adults but not in children

Name	ATC^a	Therapeutic use	Adult efficacy^b	Paediatric efficacy^b	Dosage form^c
Fresh-frozen plasma	B	Coagulation factor deficiency	Effective	No evidence	A
Dopamine	C	Heart failure	Effective	No evidence	A
Fludrocortisone	H	Adrenal insufficiency	Effective	No evidence	A
Lugol’s solution	H	Thyroid storm	Effective	No evidence	A
Levofloxacin	J	Tuberculosis	Favours efficacy	No evidence	A
Amphotericin B	J	Leishmaniasis	Effective	No evidence	A
Clofazimine	J	Leprosy	Effective	No evidence	A
Ribavirin	J	Viral haemorrhagic fevers	Favours efficacy	No evidence	A
Amitriptyline	N	Pain in palliative care	Effective	Inconclusive	A
Sodium stibogluconate	P	Leishmaniasis	Favours efficacy	No evidence	NA
Melarsoprol	P	African trypanosomiasis	Favours efficacy	No evidence	NA
Suramin sodium	P	African trypanosomiasis	Favours efficacy	No evidence	NA
Eflornithine	P	African trypanosomiasis	Effective	No evidence	NA
Triclabendazole	P	Infection by Paragonimus	Favours efficacy	Inconclusive	NA
Epinephrine (Adrenaline)	S	Mydriasis induction in cataract surgery	Favours efficacy	No evidence	A
Fomepizole	V	Ethylene glycol toxicity	Effective	Inconclusive	A
Mesna	V	Prophylaxis of ifosfamide-induced haemorrhagic cystitis	Effective	No evidence	A

^aAnatomical Therapeutic Chemical (ATC) classification code: B, blood and blood-forming organs; C, cardiovascular system; H, systemic hormonal preparations, excluding sex hormones; J, general anti-infectives for systemic use; N, nervous system; P, antiparasitic products; S, sensory organs; V, various
^bAdult or paediatric efficacy: Inconclusive, evidence is inconclusive; Favours efficacy, evidence favours efficacy
^cDosage Form: A, available; NA, not available

ISSN: 2052-3211