Patients should be educated about red flag symptoms requiring immediate medical attention, including severe persistent abdominal pain (especially if radiating to the back, suggesting possible pancreatitis), right upper quadrant pain with fever or jaundice (potential gallbladder disease), inability to keep fluids down for more than 24 hours, syncope, chest pain, or difficulty breathing
Potency verification, sterility testing, and stability data may be less extensive than what the FDA requires for approved drugs
Ann Pediatr Endocrinol Metab
J Investig Allergol Clin Immunol 29(4):251261 Manson JJ, Crooks C, Naja M, Ledlie A, Goulden B, Liddle T et al (2020) COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study