PMDAsafety guidance72% confidence
[ANZEN]PMDA Alert for Proper Use of Drugs: Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group (follow-up report) posted
Source: PMDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as BioMarin Pharmaceutical.
Regulatory Analysis
PMDA document relevant to the signal.
Supporting Context
- Therapeutic area
- Pediatrics · Growth Disorders
- Sub-indication
- Ild
Related signal: BioMarin's Study on Growth in Children with Idiopathic Short Stature Underway