TGA investigates spike in Vyvanse adverse event reports

A spike in the reporting of adverse events related to the attention deficit hyperactivity disorder (ADHD) medication lisdexamfetamine dimesilate (sold as Vyvanse) could be due to a combination of dosage issues and social media, according to one ADHD expert.
 
The Therapeutic Goods Administration (TGA) is investigating a sharp rise in the reporting of suspected adverse event reports regarding Vyvanse. 
 
Last year, there were 21 reports of the popular medication to the TGA’s Database of Adverse Event Notifications (DAEN).

However, from 1 January to 14 July 2025, there have been 330 reports – more than 15 times the total of the previous year.
 
‘Following social media commentary about this matter, there has been a recent increase in suspected adverse event reports submitted to the TGA regarding Vyvanse,’ said the TGA.
 
‘We are continuing our investigations into these reports, including reports of decreased effectiveness of Vyvanse. We are working with [manufacturer] Takeda to obtain more information, as well as undertaking independent testing in our own laboratories.’
 
Associate Professor John Kramer, Chair of RACGP Specific Interests ADHD, Autism Spectrum Disorder and Neurodiversity, told newsGP that recent coverage of the increase in adverse reports of Vyvanse is ‘particularly frustrating’.
 
‘It’s undermining confidence in the alternative to methylphenidate, which many people are having to take, or many people are having to switch to Vyvanse because they can't get the longer acting forms of methylphenidate,’ he said.
 
'I’ve actually been using much more Vyvanse this year when people need to start a trial because of the availability problems with all of the various forms of methylphenidate.’
 
The predominant suspected adverse reaction reported of Vyvanse to the DAEN is drug inefficacy (165), with other reported issues including anxiety, insomnia, condition aggravation and attention disturbance.
 
There have also been 91 reports of issues with the product packaging, with two typographical errors identified in the labelling earlier this year – first, an incorrect pluralising of ‘capsule’ to ‘capsules’, and secondly, the misspelling of ‘pharmaceuticals’ as ‘pharmaceutivals’.
 
Associate Professor Kramer said this led some people to believe ‘that had something to do with the efficacy or otherwise of the medication’.
 
‘That was enough to set off a certain amount of people, and then that feeds into social media, and then it generates its own momentum, and the facts don’t get in the way,’ he said.
 
‘It plays into a narrative where there’s always people looking for a problem with any sort of drug. It doesn’t matter what it is.’
 
Associate Professor Kramer said the reports of drug inefficacy may also be due to the medication not being correctly titrated.
 
‘It’s interesting that the first negative story was that Vyvanse didn’t work on some people, rather than it was causing side effects,’ he said.
 
‘The advice from the experts with Vyvanse is that you’ve got to carefully titrate the dose upwards as long as it’s tolerated, with no significant side effects, and then go one dose adjustment past the ideal one, which the patient will tell you, “60 milligrams doesn’t work any better than 50”, for instance, so the decision then is, “OK, go back to the 50. That’s your sweet spot”.’
 
Associate Professor Kramer said the reports on Vyvanse were a topic of conversation at last weekend’s annual Australasian ADHD Professionals Association conference in Sydney. 
 
‘It was certainly talked about a little bit, but it was more with a bit of resignation. You know, there’s nothing to this story,’ he said.

'There was a phrase that came up a number of times; “ADHD is easy to treat, but not easy to treat well”. It does require a bit of experience with the medications.’
 
A spokesperson for the manufacturer of Vyvanse, Takeda Pharmaceuticals Australia, said while the company acknowledges the typographic errors on the product packaging ‘may be a source of concern to the patient and clinical communities, they do not impact the medicine’s safety or quality’.
 
‘The errors have been corrected for future deliveries and Takeda is working with the Therapeutic Goods Administration regarding this matter,’ the spokesperson told newsGP.
 
‘We encourage anyone with questions about their treatment to discuss these with their prescribing clinician or pharmacist.’
 
A TGA spokesperson confirmed its investigation into ‘a potential safety signal associated with Vyvanse’ is continuing.
 
‘The TGA does not comment on open investigations and cannot pre-empt the outcomes or likely actions that might arise from our assessments,’ the spokesperson told newsGP.
 
‘However, the outcomes of the investigation will be communicated and published once completed, including any regulatory action if necessary.’
 
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ADHD attention deficit hyperactivity disorder medication methylphenidate Vyvanse