‘No issues of concern’ with Vyvanse: TGA

The Therapeutic Goods Administration (TGA) has given lisdexamfetamine dimesilate, sold as Vyvanse, the all-clear, after an increase in reported adverse events prompted an investigation.
 
The TGA published its findings on Friday, reporting its assessment of the medication’s effectiveness, quality and safety ‘found no issues of concern’.
 
‘Our testing found that all batches tested were compliant with expected strengths and quality,’ it said.
 
Vyvanse is commonly prescribed for the treatment of attention deficit hyperactivity disorder (ADHD) and also used to treat moderate to severe binge-eating disorder in adults.
 
The TGA investigation began in March following a sharp rise in suspected adverse events reports regarding Vyvanse, which included drug ineffectiveness, anxiety, insomnia and product label issues.
 
In April, manufacturer Takeda Pharmaceuticals Australia issued a product alert after it became aware of two typographical errors on the medication’s packaging.
 
The errors were raised in customer complaints, and concerns expressed on social media. From January to late July, more than 300 adverse event reports were made.
 
At that time, Chair of RACGP Specific Interests ADHD, Autism Spectrum Disorder and Neurodiversity, Associate Professor John Kramer, told newsGP that coverage of the increase in adverse reports was ‘frustrating’.
 
He attributed the increase to a combination of social media over the packaging’s typographical errors – which he said led some people to believe ‘that had something to do with the efficacy or otherwise of the medication’ – and potentially incorrect titrating.
 
In its findings, the TGA also noted that the increased reporting ‘appeared to be stimulated by social media commentary’.
 
It recommended health professionals be alert to the potential for patients to raise concerns about Vyvanse, but to advise that the TGA ‘found no issues’ with the medication’s quality, safety or effectiveness.
 
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ADHD attention deficit hyperactivity disorder investigation medication Vyvanse