TGA reports no safety issues with Vyvanse
30 Sep 2025
The Therapeutic Goods Administration (TGA) has cleared the medication Vyvanse (lisdexamfetamine dimesilate) of any safety concerns following an investigation prompted by a rise in reported adverse events.
The TGA’s assessment, published on Friday, found no issues with the medication’s safety, effectiveness, or quality. “Our testing found that all batches tested were compliant with expected strengths and quality,” the regulator said.
Vyvanse is commonly prescribed to treat attention deficit hyperactivity disorder (ADHD) and is also used for moderate to severe binge-eating disorder in adults.
The investigation began in March after an increase in reports of suspected adverse events, including drug ineffectiveness, anxiety, insomnia, and product label issues. In April, Takeda Pharmaceuticals Australia issued a product alert after discovering two typographical errors on the medication’s packaging, which had also been raised in customer complaints and on social media. From January to late July, more than 300 adverse event reports were received.
Associate Professor John Kramer, Chair of RACGP Specific Interests ADHD, Autism Spectrum Disorder and Neurodiversity, said the rise in reports was “frustrating” and largely influenced by social media discussions about the packaging errors, which led some patients to incorrectly question the medication’s effectiveness.
The TGA noted that social media likely contributed to the increased reporting and advised health professionals to be aware that patients may raise concerns about Vyvanse. However, the regulator emphasised that the medication’s quality, safety, and effectiveness remain uncompromised.
Source: Therapeutic Goods Administration (TGA)
