The edition · Clinical Pharmacology
One in five children starting methylphenidate dropped 10 or more weight centiles within three months
Korean hospital records put numbers on the FDA's stimulant weight warning; a decade of FDA approvals shows CYP3A interactions are still being worked out after launch; and extended cefepime infusion hits target more often against less susceptible bacteria in children.
The edition in brief
In 2,087 Korean children and adolescents starting methylphenidate, mean weight fell 0.33 kg and 2.5 centiles within three months, and 21.6% dropped 10 or more centiles, rising to 28.6% in preschool children, supporting the FDA's 2025 warning about stimulant-related weight loss in young children. Of 332 new small-molecule drugs approved by the FDA between 2015 and 2024, 51 (15%) carried post-marketing requirements or commitments to study CYP3A interactions, two-thirds of them cancer drugs; 58% of those studies led to label updates. In 75 critically ill children, prolonged cefepime infusion achieved target concentrations more often than intermittent dosing when the pathogen MIC was 1 mg/L or higher. Among 24 medicines authorised by the EMA in 2022 to 2024, pivotal trials frequently excluded people with cardiovascular, hepatic or renal disease, often without documented scientific justification. On the regulatory side, the FDA recorded a supplement to Novartis's everolimus (Zortress) application on 16 September; no details of the change are given.
About one in seven new FDA drugs launched with CYP3A interaction questions still open
For any recently approved drug, especially a kinase inhibitor, check current interaction guidance before adding or stopping a CYP3A inhibitor or inducer.
FDA records a supplement to Novartis's everolimus (Zortress) application
No action is needed now; check the Zortress label for changes once the updated version appears.
Prolonged cefepime infusion reached target more often than intermittent dosing against higher-MIC bacteria in children
For less susceptible Gram-negative infections in critically ill children, prolonged cefepime infusion improves target attainment; watch for overexposure.
EMA pivotal trials often excluded kidney, liver and heart disease without stating why
For a new drug in a patient with kidney, liver or heart disease, assume the trial evidence may not include them and monitor accordingly.
A short list of CYP3A drugs to check before any co-prescription
Clarithromycin, azoles, ritonavir, rifampicin and carbamazepine account for most dangerous CYP3A interactions; check before combining.
One in five children starting methylphenidate dropped 10 or more weight centiles within three months
Weigh and plot every child starting methylphenidate, and review at three months; in this cohort about one in five dropped 10 or more centiles.
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