Latest news with #TGA
Sky News AU
a day ago
- Health
- Sky News AU
The Project star Meshel Laurie reveals whopping 60kg weight loss as she pleads for government to add Ozempic to PBS
Meshel Laurie has got candid about her whopping 60kg weight loss as she called for a controversial obesity medication to be added to the Pharmaceutical Benefits Scheme (PBS). The Project panellist, 51, has been open about her extreme physical transformation after undergoing gastric bypass surgery in 2016, which resulted in the TV host looking completely unrecognisable. Meshel appeared on the Kyle and Jackie O show on Tuesday, where she admitted to having recently taken weight loss medication Mounjaro and credited the drug with helping her lower the scale. She called on the Albanese government to add the GLP-1 injectable drug, similar to Ozempic, to the PBS to subsidise the cost and make it more affordable for Australians, describing the effects as "amazing" and "life-changing". "I have to make a plea to the government to add this medication to the PBS, please, because it costs over $600 a month," she said. "For a lot of people, it's prohibitive." "If obesity costs Australia about $12 billion a year, then surely, we can afford to make this medication more affordable." Mounjaro was initially used for treating type 2 diabetes until it gained popularity for its weight loss effects in recent years. The Therapeutic Goods Administration (TGA) in 2024 expanded the drug's usage to encompass obese or overweight Australians with weight-related health issues like high blood pressure, heart disease or sleep apnoea. Speaking about the reported side effects, including stomach pains, Mishel said she hasn't experienced any. She said even if she had, it would be "worth it" to continue achieving a physical transformation while bypassing any "exercise" in the process. "As I said, I did everything else before. So, I lost a bit of weight, I lost about 30kg. "And then about a year ago, I started using Mounjaro. "And that has not only knocked off the next 30-40kgs, but it has absolutely dealt with the problem. Like, I don't think about food anymore." Elsewhere in the wide-ranging interview, Meshel opened up about the personal heartbreak that spurred her to lose weight in the first place. 'My dad died of Type 2 Diabetes (in) 2019,' she said. 'But for the five years before that he lived with the kids and I. 'I was watching (him suffer) in real time, out the kitchen window, because he was in a granny flat. I didn't put him in the driveway; he had a flat.' The media personality was a regular on Ten's The Project from 2014 to 2018, after which she was sacked while on leave for her father's health. Meshel said she was ready to go back to work after 12 weeks, only to be told all the "spots were filled for the next couple of months" 'In fact, I was never notified that I was being let go," she said on Instagram. Meshel subsequently carved out a career as an author and published her bestselling novel, Buddhism for the Unbelievably Busy, in 2017, followed by CSI Told You Lies: Giving Victims a Voice Through Forensics in 2021. In Buddhism for the Unbelievably Busy, Meshel declared she was "embarrassed" about having had surgery to lose weight. "Yes, it's embarrassing to have to go to that length to rein my body in, but I'd rather be embarrassed than unable to walk," she wrote. "In a way, I feel lucky to have had such clear signals from my body that I needed to turn my health burner back on, when I still had time to do something about it."
Zawya
2 days ago
- Business
- Zawya
Saudi: Ride-hailing apps complete over 32mln trips in Q2 2025
RIYADH — The Transport General Authority (TGA) announced on Sunday that ride-hailing applications in Saudi Arabia recorded over 32 million completed trips during the second quarter of 2025, marking a 104% increase compared to the same period last year. According to the TGA's latest sector index, more than 263,000 drivers are now registered on ride-hailing platforms — a growth rate of 81% — underscoring the rising popularity of digital transport services in the Kingdom. The number of operating platforms reached 15,300, reflecting an 87% year-on-year increase. Regionally, Riyadh accounted for the highest share of total trips at 41%, followed by Makkah at 22.5%, the Eastern Province at 15.7%, and Madinah at 6.1%. Other regions included Asir (3.4%), Qassim (3.2%), Tabuk (2.7%), Hail (1.9%), Jazan (1.3%), Najran (0.7%), Al-Jouf (0.6%), Northern Borders (0.3%), and Al-Baha (0.3%). The authority emphasized its ongoing efforts to enhance the quality and reliability of ride-hailing services across the Kingdom. The initiative aims to ensure high standards of efficiency and user satisfaction in response to growing demand nationwide. © Copyright 2022 The Saudi Gazette. All Rights Reserved. Provided by SyndiGate Media Inc. (
Japan Today
3 days ago
- Health
- Japan Today
Is spinal cord stimulation safe? Does it work? Here's what you need to know if you have back pain
By Caitlin Jones and Christopher Maher Spinal cord stimulators are electrical devices that are surgically implanted in the body to treat long-term pain. They have a battery pack and leads that deliver electrical impulses directly to the spinal cord. The devices are thought to work by providing electrical impulses that interfere with how the brain senses pain. Spinal cord stimulators are mainly used to treat chronic back pain, especially when other less invasive treatments have not worked. They also aim to reduce people's reliance on risky pain medicines. These include opioids, which research shows are ineffective and harmful for low-back pain. But research, including our own, shows spinal cord stimulators work no better than a placebo. And they can also carry risks. Do they work? In a 2023 Cochrane review, researchers reviewed data from 13 randomized controlled trials on low-back pain and found no benefits in the short and medium term. These international reviews draw together the most robust evidence to provide a detailed summary of what we know on a particular topic. Only one of the trials in the review tested efficacy in the longer term (six months). That trial found no benefits of spinal cord stimulation. An earlier Cochrane review looked at the evidence of spinal cord stimulation for chronic pain in general, including for neck pain. Reviewers looked at 15 randomised controlled trials and couldn't be certain about its benefits, largely due to the quality and reliability of the available trials. Are there side effects? Aside from disappointing results for pain relief, there are risks and side effects to consider. We co-authored an analysis of 520 adverse events reported to Australia's Therapeutic Goods Administration (TGA). We found 79% of reported events were rated as severe, with 13% life-threatening. The same research found 80% of events required surgery to correct. Our recent analysis in the Medical Journal of Australia looked at data from private health insurers. These cover 90% of spinal cord stimulation implants in Australia. Five major insurers, which covered 76% of privately insured people, contributed de-identified data. We found about one-quarter of people who had a spinal cord stimulator implanted needed corrective surgery afterwards. These surgeries occurred within a median of about 17 months. This indicates these surgeries are not routine or expected interventions, such as to replace batteries, which are meant to last five to ten years. Our previous research shows the sorts of reasons for corrective surgery. These include to replace a malfunctioning device, or the person was in more pain, had an infection, or a puncture of the delicate tissues covering the spinal cord. However, even our latest findings are likely to underestimate the risk of these devices. Sometimes the lead delivering the electrical current moves away from the spinal cord to elsewhere in the body. This requires surgery to reposition the lead, but does not necessarily require new hardware, such as a brand new lead. So this type of corrective surgery is not counted in the data from the private health insurance companies. How much does it cost? We found spinal cord stimulators cost about A$55,000 per patient, including the device, its insertion, and managing any associated additional surgeries. For people who only had a 'trial' – where the leads are implanted temporarily but the battery pack remains outside the body – this cost was about $14,000 per patient. These figures do not include any out-of-pocket costs. What do regulators say about the devices? In 2022 the TGA began a review of spinal cord stimulators on the market because of safety and performance concerns. As a result, several devices were removed from the Australian Register of Therapeutic Goods – that is, they were banned from use in Australia, but existing stock could still be used. The rest of the devices had conditions imposed, such as the manufacturers being required to collect and report safety data to the TGA at regular time points. Should I do my own online research? Yes, but be careful. Unfortunately not all online information about spinal cord stimulators is correct. Look for sites independent of those who manufacture or implant these devices. Government agencies, health departments and universities that have no financial interests in this area may be a better option. The Cochrane Library is also a reliable and independent source for trustworthy health information. What shall I ask my doctor? The Australian health department provides useful advice for consumers about medical implants. It says medical implants 'are considered higher-risk therapeutic goods, and the decision to get one should not be taken lightly'. It recommends asking your health professional these questions: do I really need this medical implant? what are the risks/benefits? is the medical implant approved? where can I get more information? what happens if I experience an adverse event? What else could I do for my back pain? There are other treatment options that are effective and have fewer risks than spinal cord stimulation. For example, education about how to manage your pain yourself, exercise, cognitive behavioral therapy (a type of psychological therapy), and non-steroidal anti-inflammatory medicines (such as ibuprofen) all have solid evidence to back them. All offer benefits that are not outweighed by their potential risks. Research has shown other types of therapy – such as sensorimotor retraining and cognitive functional therapy – are also effective. You can discuss these and other options with your health professional. Spinal cord stimulation is a good example of a treatment that got ahead of the evidence. Although the devices have been around since the 1960s, we've only had reliable trials to test whether they work in recent years. Everyone wants to find ways to help people with chronic pain, but we must ensure medical care is grounded in reliable science. Caitlin Jones is Postdoctoral Research Associate in Musculoskeletal Health, University of Sydney. Christopher Maher is Professor, Sydney School of Public Health, University of Sydney. The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts. External Link © The Conversation
The Australian
4 days ago
- Health
- The Australian
Spike in adverse event reports for ADHD medication Vyvanse
Authorities are investigating a spike in incidents involving one of Australia's most widely used ADHD medications. 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
Sky News AU
4 days ago
- Health
- Sky News AU
Spike in adverse event reports for ADHD medication Vyvanse
Authorities are investigating a spike in incidents involving one of Australia's most widely used ADHD medications. 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. Originally published as Spike in ADHD medication adverse event reports
