Overview

• TGA records show adverse event notifications for Vyvanse surged to 320 in the first half of 2025, a steep rise from nine in the latter half of 2024.
• The TGA Laboratories has started independent testing of Vyvanse samples to investigate potential quality or safety concerns.
• Reports primarily involve anxiety, diminished effectiveness and insomnia, though database listings do not establish causation.
• The regulator flagged a minor label typo earlier this year and confirms there are no compliance breaches at the drug’s manufacturing facilities.
• Vyvanse prescriptions climbed from 958,000 in 2022 to 1.8 million last year as ADHD diagnoses increased and self-diagnosis inquiries rose fivefold.