Spike in ADHD medication reports
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.'
'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.
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
Pharmacies warn of unsustainable demand for weight loss medication
The booming demand for weight loss jabs may be unsustainable, pharmacists warn. Many more patients are interested in using weight loss medication than are actually suitable for treatment, according to the National Pharmacy Association (NPA), which represents more than 6,000 independent community pharmacies. Some 21% of people who were interviewed in a NPA-commissioned poll agreed they had attempted to access weight loss treatments in the last year, either online or in person at a pharmacy, rising to 35% of 16 to 34-year-olds. This is compared to only 7% of those over 55. There were also 41% who agreed they would opt for weight loss treatments on the NHS if they were made available to them. This figure rose to 64% among 25 to 34-year-olds, despite many of these patients being unlikely to be clinically eligible. The NPA says the poll, in which 2,002 people were interviewed, reflects an increasing demand for private and NHS weight loss services. NPA chairman Olivier Picard said: 'Weight loss jabs are one of the biggest drug innovations this century, but growing demand for weight loss treatment highlights the need to make sure this is appropriate for those who want it. 'It's clear from this polling that many more people are interested in getting weight loss jabs than would actually be suitable for treatment. 'We want to make sure supplies are carefully managed so that those in most clinical need can benefit from weight loss medication.' Spiralling demand, fuelled partly by social media, could see people being tempted to resort to unregulated online suppliers instead of regulated pharmacies staffed by medical professionals, they fear. Online suppliers may not be offering weight loss jabs alongside a structured programme aimed at helping them change their behaviour. Wegovy and Mounjaro are among a number of drugs that are recommended to help tackle obesity on the NHS. Mounjaro and Wegovy are licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in patients with a BMI of over 30 or between 27 and 30 but with a weight-related co-morbidity. This occurs when an individual who has obesity develops another medical condition due to their weight. The NHS currently rolls out Mounjaro to patients with a BMI of over 40 and at least four co-morbidities, the NPA says. The NPA is calling for new regulations to protect patients buying weight loss medication online, so there is a full two-way consultation and all relevant historical medical records are reviewed before the treatment is prescribed. They are waiting for more details about the role pharmacies could play in the rollout of the NHS weight management programme. At least 85% of weight loss medication prescriptions were made by pharmacies in April this year, the NPA estimates. Mr Picard said: 'Pharmacists are experts in medication and many have extensive experience delivering weight loss injections as part of a package of care, including lifestyle advice. 'Pharmacies are well placed to help roll this treatment out on the NHS, and help people make the best use of these powerful medicines.'
Yahoo
3 hours ago
- Yahoo
AESTURA, Korea's #1 Dermatologist-Recommended Dermocosmetic Brand Launches Exclusively at Sephora Australia
Premium dermocosmetic brand specialising in sensitive skin launches from August 26th, bringing clinically-proven innovation to Australian skincare market SYDNEY, July 28, 2025 /PRNewswire/ -- AESTURA, Korea's #1 dermatologist-recommended dermocosmetic brand for sensitive skin[1], breaks new ground in the Australian skincare market with its exclusive launch at Sephora Australia stores and on beginning August 26th, 2025. This strategic partnership with Sephora Australia answers the growing demand for advanced, science-backed solutions in the dermatologist skincare category. AESTURA is more than just a skincare brand. It is the culmination of over 40 years of scientific research and dermatological expertise. AESTURA's specialised sensitive skin solutions are trusted by dermatologists at Korea's leading medical institutions. The brand has been ranked as the No. 1 cosmetic brand sold in skin clinics for 9 consecutive years[2], and has widespread distribution, reaching 100% of tertiary general hospitals in South Korea[3]. "We are thrilled to introduce AESTURA to our Australian beauty community," says Sheila Dam, Brand General Manager at AESTURA. "Our products and formulas have been trusted by Korean dermatologists and sensitive-skin users alike for decades, and now, with this launch at Sephora Australia, we are excited to share these innovative sensitive-skin solutions to a wider audience." AESTURA's innovative skincare harnesses patented Triple-Lipid Technology™, featuring one million ceramide capsules in every bottle engineered to mimic the skin's natural structure and target the fundamental pillars of skin health: hydration, protection, and restoration. The ATOBARRIER365 Collection: Hero Products for Sensitive Skin At the heart of AESTURA's breakthrough skincare is the ATOBARRIER365 Collection, featuring the viral sensation ATOBARRIER365 Cream. The hero product has become a phenomenon in Korea, with one cream sold every 7 seconds[6] due to its proven ability to strengthen, protect and hydrate the skin. The ATOBARRIER365 Cream features patented technology with one million capsules packed with ceramides in every bottle[4]. These capsules stay on the skin for up to 18 hours[5], delivering hydration while strengthening, repairing, and protecting the moisture barrier which can be weakened in sensitive skin. "Sensitive skin often struggles with compromised skin barrier, making it more susceptible to dryness and irritation," says Dr. Richard D. Granstein, an academic dermatologist and Chair of AESTURA's Derma-Science Advisory Board. Additionally, according to Dr. Y. Claire Chang, board-certified dermatologist at UnionDerm and clinical instructor at Mount Sinai Hospital, "For those with sensitive skin, ceramides are crucial. It's not just about any ceramides, though. Sensitive skin benefits most from specific ceramides that mimic those naturally found in the skin. AESTURA's innovative capsule technology, used in the ATOBARRIER365 Cream, encapsulates these barrier-boosting ceramides, allowing for deeper penetration to help rebuild and strengthen the skin's natural barrier. Results reported from a clinical trial of the ATOBARRIER365 Cream demonstrated significantly enhanced skin hydration and improved barrier function." The complete ATOBARRIER365 Collection includes products formulated to address specific skin concerns like dryness, irritation, and barrier damage while enhancing overall skin health. Each product is designed for daily use, providing a complete routine specifically developed for sensitive skin needs. Exclusive Launch at Sephora Australia The exclusive partnership with Sephora Australia underscores both brands' commitment to offering premium, results-driven skincare solutions. Sephora's reputation for curating the world's most coveted beauty brands makes it the ideal retail partner for AESTURA's Australian debut. "Sephora Australia is excited to exclusively launch AESTURA, bringing our clients access to Korea's most trusted dermocosmetic brand," says Mark O'Keefe, Country Manager Sephora ANZ. "Our clients value effective, results-driven skincare, and AESTURA delivers on this by offering cutting-edge solutions specifically designed for sensitive skin that support barrier health. We look forward to introducing AESTURA to our Sephora community and know that it will be a valuable addition to our assortment." Market Impact and Availability The Australian launch comes at a time when consumer interest in K-beauty and dermocosmetic products continues to grow, with Australian consumers increasingly seeking scientifically-backed skincare solutions and prioritising genuine skin health over trend-driven routines. Australia's harsh environmental factors - from intense UV exposure to dramatic seasonal transitions - demand skincare solutions of exceptional calibre. AESTURA's arrival fills a crucial gap in the market for dermatologist-recommended brand that combine Korean innovation with clinical credibility. Starting August 26th, AESTURA products will be available at all Sephora Australia and New Zealand stores nationwide and through Sephora's online platform, ensuring accessibility for customers across the country. [1]Based on research conducted by Kantar with dermatologists in South Korea, 2023. [2]Korea Consumer Agency, 2016-2024, Best Brand Award of the Year in the category of cosmetic brands sold in skin clinics. [3]Distribution Partners Based on Health Insurance Review & Assessment Service (HIRA) Statistical Figures [4]80mL/2.7 fl. oz. [5]Ex-vivo test on human skin [6]3M Units Sales: 2018.09 ~ 2024.01 cumulative unit sales1 sold every 7 seconds : 2024.01 unit sales About AESTURA AESTURA is Korea's #1 dermatologist-recommended dermocosmetic brand, dedicated to developing scientifically-proven skincare solutions that bridge the gap between cosmetics and dermatological care. Founded on the principle of combining advanced research with gentle effectiveness, AESTURA has earned the trust of Korean dermatologists and consumers alike. The brand's commitment to clinical excellence and innovation has made it a leader in the Korean beauty industry and a sought-after name in global skincare markets. For more information about AESTURA, visit View original content to download multimedia: SOURCE AESTURA Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 hours ago
- Yahoo
Major update on plan to slash prescription medications to $25 for millions
The federal government will introduce legislation to parliament to cap the cost of Pharmaceutical Benefits Scheme (PBS) prescriptions to $25 this week. The cost-of-living move was one of Labor's major election promises and will save Aussies $200 million per year. Once passed, eligible medicines would be lowered from $31.60 to $25 from January 1 next year. Pensioners and concession cardholders will continue to pay just $7.70 for their prescriptions until at least 2030. Prime Minister Anthony Albanese said the cap was an example of cost-of-living relief that helped 'every Australian'. RELATED Major update on $5,520 HECS cash boost for millions to lift them out of debt Major warning after Aussie receives random $350 payment in her bank account Aussie 'appalled' by $4,000 ATO tax bill after common deductions rejected 'The size of your bank balance shouldn't determine the quality of your healthcare. My government will continue to deliver cost-of-living relief for all Australians,' he said. Health Minister Mark Butler said the move meant medicines would be their cheapest in decades. 'Cheaper medicines are good for the hip pocket and good for your health,' he said. 'For general patients, medicines haven't been this cheap since 2004." The change would lower the price of medicines by more than 20 per cent and follows an earlier round of price reductions in 2023. The government previously cut the maximum price of a PBS script from $42.50 to $30. The bill comes after US President Donald Trump flagged tariffs of up to 200 per cent on pharmaceuticals earlier this month. Pharmaceuticals are one of Australia's biggest exports to the US. According to the UN's Comtrade database, Australia exported $2.2 billion in products to the US last year. The Australian government has said it is not willing to trade away or do deals on the PBS. How will the cheaper medicines work? The PBS is the government subsidy program that allows Australians to get a wide range of prescription medicines at more affordable prices. There are two main prices for PBS medicines. The general rate is what applies to most people and is what would be lowered from $31.60 to $25. The concessional rate applies to concession-card holders and is currently frozen at $7.70 until 2030. There are more than 900 medicines on the PBS schedule, spread across more than 5,000 brands. You can check if your medication is on the PBS here.
