Skip to main content

Table 2 Number of neonates exposed to potentially hazardous excipients (PHEs) and prescriptions and products containing PHEs

From: Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan

Excipients PMA at dose (weeks), median (range) Weight at dose (g), median (range) Total Parenteral Enteral Topical
No. of neonates (N = 343) No. of prescriptions (N = 2360) No. of products (N = 426) No. of neonates (N = 225) No. of prescriptions (N = 1475) No. of products (N = 291) No. of neonates (N = 200) No. of prescriptions (N = 763) No. of products (N = 104) No. of neonates (N = 82) No. of prescriptions (N = 122) No. of products (N = 31)
Aspartame 45.4 (35.0–67.6) 3375 (1634–3962) 13 15 6 0 0 0 13 15 6 0 0 0
Benzalkonium chloride 41.6 (38.6–44.6) 2818 (263.–3006) 3 6 2 0 0 0 0 0 0 3 6 2
Benzyl alcohol 34.9 (23.3–71.1) 1808 (486–6665) 100 137 10 98 137 10 0 0 0 0 0 0
Ethanol 36.9 (23.9–71.1) 1820 (575–6665) 130 193 8 10 1 2 130 192 6 0 0 0
Parabens 38.0 (24.4–71.1) 2062 (410–7505) 86 107 8 13 5 4 43 53 3 49 49 1
Polysorbate 80 34.9 (23.3–71.1) 1792 (487–6665) 106 115 17 91 97 8 10 11 6 6 7 3
Propylene glycol 36.6 (23.7–55.7) 2116 (486–4175) 71 71 7 39 41 3 30 30 4 0 0 0
Saccharin sodium 35.7 (23.9–63.7) 1768 (575–5162) 67 78 8 0 0 0 67 78 8 0 0 0
Sodium benzoate 36.7 (23.9–67.6) 1768 (575–5162) 153 217 9 0 0 0 153 215 9 0 0 0
Sorbitol 36.9 (23.9–67.6) 1909 (410–5162) 161 170 6 23 30 3 140 140 3 0 0 0
At least one PHE 36.0 (23.3–71.1) 1808 (410–7505) 282 646 52 157 284 29 172 308 19 57 54 4
  1. PMA postmenstrual age