Spike in adverse event reports for ADHD medication Vyvanse
Adverse event reports linked to medication Vyvanse have spiked massively this year, and the manufacturer says no changes in the chemical production have been made.
'The Therapeutic Goods Administration (TGA) is currently investigating a potential safety signal associated with Vyvanse, including independent testing of the medicine through the TGA Laboratories,' a spokesperson told NewsWire.
'The investigation is the result of a recent increase in adverse event notifications relating to concerns about the quality, safety, and reduced effectiveness of the drug.'
The TGA issued an alert about a typo on the Vyvanse label earlier this year. Picture: TGA
'There are no compliance signals currently under investigation for the facilities used in the manufacture of this product.'
A 'signal' is detection of a pattern which requires further investigation.
While not formally a pattern in the TGA's eyes, reports of adverse events such as anxiety, ineffectiveness and insomnia have increased massively this year. There have also been 88 reports of issues with the medicines label, which was flagged by the TGA earlier this year for minor typos; however, one of the typos added an extra 'S' to the word capsule; 'Each capsules contains 60mg lisdexamfetamine dimesilate'.
The TGA maintains the Database of Adverse Event Notifications, where people report issues with medications.
There have been 320 adverse events linked to Vyvanse in the first half of this year, compared to nine reports in the second half of 2024.
Inclusion in the database does not confirm the incident is caused by the medication.
Reports of ineffective Vyvanse have hit 150 so far this year, along with 88 reports of anxiety, and 73 reports that the therapeutic response has decreased.
Last year, 1.8m Vyvanse prescriptions were written in Australia, excluding Department of Veterans' Affairs patients, over-the-counter drugs, private prescriptions and public inpatient prescriptions. Picture: NewsWire / Martin Ollman
Prescriptions of Vyvanse have been steadily increasing for the past few years. More than 958,000 scripts were written by public system health workers in 2022, rising to 1.4 million in 2023, and then 1.8m last year, government data shows.
In a statement, supplier Takeda Pharmaceuticals Australia said a change of manufacturing facility in 2024 did not alter the chemical composition of the medicine.
'There have been no changes to the formulation,' a Takeda spokesperson told the ABC.
Vyvanse was produced with strict quality controls, in line with Australia's Therapeutics Goods Act, the spokesperson said.
The labelling typo did not affect the quality of the medication, they said.
Blair Jackson
Reporter
Blair's journalism career has taken him from Perth, to New Zealand, Queensland and now Melbourne.
Blair Jackson
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
News.com.au
5 hours ago
- News.com.au
Concerning daycare images show children with their mouths taped shut in yoga exercise
A Sydney daycare centre has received a warning from the NSW Department of Education after concerning images emerged of children with their mouths covered with tape. The toddlers at Heritage House in Wahroonga, on Sydney's north shore, were participating in a breathing exercise as part of a yoga session last year. No injuries were reported from the exercise which was meant to be relaxing, but the Department launched an investigation into the matter after concerns were raised by a parent. 'While no children were harmed in this incident, it was an inappropriate activity that should not have taken place in an early learning centre,' a spokesperson from the NSW Early Childhood Education and Care Regulatory Authority told 'A thorough investigation was immediately conducted and a compliance action issued to the approved provider, which remains on their record.'  An external visitor was not running the yoga session, and the centre provided evidence to the Department that the mouth taping exercise has since been discontinued.  In a statement, Heritage House told the Sydney Morning Herald: 'It was a well-intentioned activity led by one of our educators, a yoga instructor.' 'We accept that the Department issued a warning and as a result we took steps to ensure that the activity was not repeated.' Photos of the activity were shared on the centre's parents app alongside a caption where an educator described the activity as 'unique'. 'The children gathered for a unique lesson combining breathwork, gentle yoga, and the tape-mouth technique. Guided to focus on nasal breathing, they playfully mimicked animals in yoga poses, learning to breathe deeply and calmly through their noses, fostering early mindfulness,' they wrote, according to SMH. A number of parents whose children attend the daycare threw their support behind the centre and its educators on Tuesday. One parent told 7News: 'They've always been very careful about the kids, their growth, their education, everything.' Another said: 'People are friendly, they seem engaged, kids are happy here.' Mouth taping, specifically for adults prone to mouth breathing while sleeping, has become a recent trend on TikTok but concerns have been raised about the dangers of restricting airflow.
The Australian
7 hours ago
- The Australian
EMVision to start two key studies
EMVision receives ethics approval for two studies that will advance prototype First Responder toward commercial production Studies designed to demonstrate First Responder brain scanner can fit into emergency workflows and collect valuable data in pre-hospital setting EMVision non-dilutive milestone payment received under Australian Stroke Alliance Project Agreement Special Report: EMVision Medical Devices has passed a major milestone with ethics approval granted for two key studies to advance its First Responder prototype portable device to detect stroke and traumatic brain injury (TBI). EMVision Medical Devices (ASX:EMV) said the Royal Flying Doctor Service (RFDS) pre-hospital aeromedical study and Melbourne Mobile Stroke Unit (MSU) study would advance its First Responder brain scanner toward commercial production. The studies are designed to demonstrate that the First Responder device can fit seamlessly into emergency workflows and collect valuable data in the pre-hospital setting. First Responder is EMVision's second device and designed to address significant unmet needs in stroke and TBI care by enabling earlier triage, transfer or treatment decisions at the scene. The device is being advanced in parallel with its emu bedside scanner to rapidly diagnose stroke at the point-of-care, which is currently in a pivotal trial to support US Food and Drug (FDA) de novo (new device) clearance. RFDS pre-hospital aeromedical study Ethics approval has been granted for a feasibility, usability and workflow implementation aeromedical study. The study is a collaboration of RFDS, South Australia Ambulance Service's emergency retrieval service MedStar, South Australia Health's Rural Support Services, the Royal Adelaide Hospital and the Australian Stroke Alliance. The study will evaluate the First Responder device's usability, reliability, functionality, workflow metrics and other tests as necessary to meet user and international regulatory requirements. EMVision said the study was on track to start recruitment this quarter, with study results expected to be reported next quarter. Melbourne Mobile Stroke Unit (MSU) Ethics approval has also been granted for a First Responder study during acute suspected stroke cases attended by the Melbourne Mobile Stroke Unit (MSU). EMVision said the study provided a unique opportunity to collaborate with the only MSUs in Australia and one of a few MSUs globally who participate in clinical research. The study aims to evaluate the use of First Responder during pre-hospital emergency response to acute suspected stroke patients, while gathering contemporaneous ground-truth MSU CT-scan data. This study is forecast to start later this quarter. Milestone payment of $400,000 from ASA In a further boost EMVision has reached a key development milestone under its project agreement with the Australian Stroke Alliance (ASA), supported by the Federal Government's Medical Research Future Fund (MRFF). The company has received a $400,000 non-dilutive payment for completing the Telemedicine and Road/Air Integration milestone, an achievement that advances its First Responder portable brain scanner program. EMVision's CEO Scott Kirkland said the company was delighted to report successful achievement of the important milestone, which brings together the power of its point-of-care neurodiagnostic capabilities with the reach of telehealth. 'This combination has the potential to transform patient workflows and outcomes, particularly in the pre-hospital setting,' he said. 'In the coming months, EMVision will be conducting several studies to progress development of its First Responder device, which will be integral to expediating its commercialisation via the FDA 510(k) regulatory pathway. 'We look forward to communicating the results of these studies to the market in due course.' First responder pathway to market entry Source:EMVision This article was developed in collaboration with EMVIsion, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
News.com.au
8 hours ago
- News.com.au
Albanese government praises ‘critical' program in teen vape fight
The Albanese government is celebrating after a key study found an anti-vaping program is helping curb the spike in fuming teens. A randomised controlled trial involving some 5000 students from 40 schools found participants were 65 per cent less likely to vape after 12 months when compared to students who did not take part in the program. The findings were published on Tuesday in the world leading health journal, The Lancet. Health Minister Mark Butler praised the results, calling the program 'a critical part of our vaping strategy'. 'Vaping rates exploded, especially in the last five years, literally exploded year on year,' Mr Butler told reporters at Parliament House, flanked by students. 'This was sold to countries around the world as a therapeutic good that would allow hardened smokers, usually in middle age, to kick the habit if other attempts to kick smoking had not worked. 'But what we found relatively quickly was this was quite a different strategy by big tobacco. 'It was a strategy to recruit a new generation to nicotine addiction.' He said he was 'delighted we have been able to fund' the program, run by the Our Futures Institute. Under the program, students learn about the harms of vaping through visual stories and game-like activities, such as quizzes. In 2019, 9.6 per cent of teens aged 14-17 were estimated to have used vapes, according to official data. It nearly tripled to 28 per cent by 2023. Earlier this year, the Albanese government said numbers the numbers were falling after a series of measures aimed at curbing the uptake among young Australians. Among the measures were banning single-use vapes. According data put out in January, vaping rates for Australian 15 and had fallen more than a third since 2023. The data also showed the number of 'never-vapers' among 14-17-year-olds had reached a record high of 85 per cent.
