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.' The TGA issued an alert about a typo on the Vyvanse label earlier this year. TGA Credit: Supplied
'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 Banyans Healthcare Founder Ruth Limkin discusses the 'staggering increase' in self-diagnosed ADHD. ADHD rates are on the rise in Australia, with the number of prescriptions for ADHD medication seeing a sharp increase. 'One of the things we've noticed at The Banyans, we've seen a 500 per cent increase in people contacting us looking for treatment who have self-reported ADHD,' Ms Limkin told Sky News Australia. 'Which is a staggering increase.'
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. NewsWire / Martin Ollman Credit: News Corp Australia
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.
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The Advertiser
2 hours ago
- The Advertiser
For 10 years, Penny was treating her symptoms with the very thing poisoning her
Penny Thompson spent nearly 13 years and thousands of dollars trying to get a diagnosis for her "mystery illness", which paralysed her vocal cords, damaged her nerves and left her unable to work, socialise or study. Finally, last year, with a litany of specialists left scratching their heads, the NSW Illawarra region woman began to suspect that the very things she had been using to ease her symptoms were actually poisoning her. Now, grieving and overwhelmed by all she has lost over more than a decade, Ms Thompson, 61, of Wollongong, south of Sydney, has registered her interest in a class action against supplement giant Blackmores, as health practitioners and patients begin to realise the extent of vitamin B6 poisoning. "Before this happened, I was a bloody fitness instructor and now I struggle to work," she said. "I haven't been out socially at night for 10 years. I can't drive for more than 20 minutes. I can't go travelling, I can't go bushwalking. "I struggle to work in my garden at home and it took me nine-and-a-half years to complete a three year university degree. "I just feel overwhelmed, I get angry, I get full of grief for all I've lost." In recent months, there have been growing reports of toxicity related to vitamin B6, which is naturally found in meat, fruit and vegetables but which is also now added to many vitamin supplements, shakes and energy drinks and is present in thousands of products on the Australian market.. According to the Therapeutic Goods Administration, taking too much can cause nerve damage, which many people experience as peripheral neuropathy - or numbness and tingling in the fingers and toes. After an increase in reports about this condition, the regulator recently recommended stricter regulations and stronger warnings. It has also noted that there is no consensus on a safe level of B6. In May, Melbourne's Polaris Lawyers announced it was pursuing a class action investigation against Blackmores, on behalf of anyone who has suffered injuries after taking its supplements "containing higher than recommended levels of vitamin B6". A Blackmores spokesperson said the company was committed to the highest standards of product quality and consumer safety. "All our products, including those containing vitamin B6, are developed in strict accordance with the regulatory requirements of the Therapeutic Goods Administration (TGA)," they said. They said the company would "ensure full compliance" with any changes the regulator makes. Ms Thompson's health struggles began back in 2012, when she went to the GP complaining of numbness in her hands and feet. She had recently moved back to Australia, and was busy and tired working three jobs and buying a house, so started taking vitamin supplements "to give me energy". "I just didn't feel right and my hands and feet were a bit numb but my GP said it was my age, or probably menopause," she said. "I said, 'I've seemed to lose weight', and he just went, 'fancy a woman in her 40s complaining of losing weight, ha ha ha', so I just left it." "But I was getting more and more fatigued and so, in 2013, I started keeping a really detailed health diary because I thought maybe I had a food allergy because I thought I was being poisoned." That kicked off a "pretty expensive" 10-year journey of seeing specialists, including neurologists, ENT doctors, cardiologists, pain specialists, rheumatologists and having nerve conduction studies or tests for heavy metals poisoning. "I was always very thorough when I saw them, because I was studying science, and I was keeping these diaries and they'd always ask you on the new patient form, please list all your medications, prescription and non-prescription so I'd write this huge list of stuff down, but none of them said anything." By late 2019, when she was working as an English teacher at TAFE, she noticed her voice changing. "I was working about three days a week and I just noticed that my voice was starting to get very, very soft, very weak, very tired," she said. "It was when the drought was happening and there were lots of bushfires, smoke and dust and I thought that's what was causing it. "But that winter I'd had a doctor who said taking zinc was good for preventing respiratory disease - I wanted to choose the best and so I bought Blackmores Bio Zinc, but what I didn't realise was that it had 50mg of B6 in it." "I was popping these things every day, and I can see now that my symptoms - like headaches and migraines and gut pain and constipation were adding up, and by September my voice had become really weak and strained. "I just thought it was the dust and the bushfires and I just kept taking the B6, and then I'd lost my voice completely and had to give up work." As COVID hit, she was diagnosed with a completely paralysed left vocal cord, but was left without medical support. She began experiencing cramps, and started taking another supplement called Super Magnesium. "It also had 50 mg of B6 and, because I was getting all these migraines and I was pretty stressed because I'd lost my job and the whole COVID crap was starting, I was also taking Blackmores Executive Stress, which had another 25 milligrams of B6," Ms Thompson said. "At one stage that I was taking 125mg per day of B6, and just feeling worse and worse and worse." Years and many more appointments on, in September 2024, Ms Thompson saw a warning on the Therapeutic Goods Administration that made her suspect that her vitamins may have been poisoning her. She stopped taking them. "Magically, the gut pain, the constipation, the food intolerances all just disappeared within a couple of months," she said. "The anxiety lifted, the migraines eased off, the twitching and all that stuff just disappeared." "I've still got a base level of numb hands and feet, my voice hasn't improved and the fatigue hasn't improved. The weight loss and the muscle wasting has, in fact, got worse. "So I still can't work because I'm so fatigued and my voice is pretty crappy." In January, B6 poisoning hit the news, with the ABC's 730 running a report featuring patients who had similar symptoms and experiences to Ms Thompson. "I recognised my story and I just went, 'oh God, that's it'," she said. "I went back through all my diaries, 10 years of diaries, with orange highlighter and calculated all the B6 and just went, 'Oh my God'." Then, armed with a print-out of an Illawarra Mercury -an ACM mastheadarticle on the issue, in which Fairy Meadow, Wollongong, GP Kate McCullough issued a warning about high doses of the vitamin, she managed to convince her doctor to run a test. She has since been diagnosed with "B6 hypervitaminosis", and in recent months registered her interest in Polaris' proposed class action, which she hopes might stop others from going through her ordeal. Already the law firm says its has received more than 900 inquiries about the class action. "I just remember at one point, my doctor said, 'oh gee, Penny, I hate to think we're missing something'," Ms Thompson said. "Of course, I'd given him all the big lists of all the supplements I was taking, but he didn't know anything about it. None of the specialists knew about it." "Despite all the media coverage this year, and repeated alerts from the TGA, most doctors and allied health professionals are still completely unaware of B6 toxicity, how serious the resulting symptoms can be and how widespread it is becoming. "I'm really hoping the class action will generate enough publicity to turn this issue around." "And I'm hoping that this kicks up so much of a stink that all of these vitamin companies and the energy drink companies and the processed food manufacturers, they all stop putting more than the recommended daily dose into their products. "I want everybody to know about it, so every doctor in Australia knows about it and we can stop the tide of this epidemic of poisoning." A Blackmores spokesperson said it had received no formal legal claim, but was aware of reports about the class action. Penny Thompson spent nearly 13 years and thousands of dollars trying to get a diagnosis for her "mystery illness", which paralysed her vocal cords, damaged her nerves and left her unable to work, socialise or study. Finally, last year, with a litany of specialists left scratching their heads, the NSW Illawarra region woman began to suspect that the very things she had been using to ease her symptoms were actually poisoning her. Now, grieving and overwhelmed by all she has lost over more than a decade, Ms Thompson, 61, of Wollongong, south of Sydney, has registered her interest in a class action against supplement giant Blackmores, as health practitioners and patients begin to realise the extent of vitamin B6 poisoning. "Before this happened, I was a bloody fitness instructor and now I struggle to work," she said. "I haven't been out socially at night for 10 years. I can't drive for more than 20 minutes. I can't go travelling, I can't go bushwalking. "I struggle to work in my garden at home and it took me nine-and-a-half years to complete a three year university degree. "I just feel overwhelmed, I get angry, I get full of grief for all I've lost." In recent months, there have been growing reports of toxicity related to vitamin B6, which is naturally found in meat, fruit and vegetables but which is also now added to many vitamin supplements, shakes and energy drinks and is present in thousands of products on the Australian market.. According to the Therapeutic Goods Administration, taking too much can cause nerve damage, which many people experience as peripheral neuropathy - or numbness and tingling in the fingers and toes. After an increase in reports about this condition, the regulator recently recommended stricter regulations and stronger warnings. It has also noted that there is no consensus on a safe level of B6. In May, Melbourne's Polaris Lawyers announced it was pursuing a class action investigation against Blackmores, on behalf of anyone who has suffered injuries after taking its supplements "containing higher than recommended levels of vitamin B6". A Blackmores spokesperson said the company was committed to the highest standards of product quality and consumer safety. "All our products, including those containing vitamin B6, are developed in strict accordance with the regulatory requirements of the Therapeutic Goods Administration (TGA)," they said. They said the company would "ensure full compliance" with any changes the regulator makes. Ms Thompson's health struggles began back in 2012, when she went to the GP complaining of numbness in her hands and feet. She had recently moved back to Australia, and was busy and tired working three jobs and buying a house, so started taking vitamin supplements "to give me energy". "I just didn't feel right and my hands and feet were a bit numb but my GP said it was my age, or probably menopause," she said. "I said, 'I've seemed to lose weight', and he just went, 'fancy a woman in her 40s complaining of losing weight, ha ha ha', so I just left it." "But I was getting more and more fatigued and so, in 2013, I started keeping a really detailed health diary because I thought maybe I had a food allergy because I thought I was being poisoned." That kicked off a "pretty expensive" 10-year journey of seeing specialists, including neurologists, ENT doctors, cardiologists, pain specialists, rheumatologists and having nerve conduction studies or tests for heavy metals poisoning. "I was always very thorough when I saw them, because I was studying science, and I was keeping these diaries and they'd always ask you on the new patient form, please list all your medications, prescription and non-prescription so I'd write this huge list of stuff down, but none of them said anything." By late 2019, when she was working as an English teacher at TAFE, she noticed her voice changing. "I was working about three days a week and I just noticed that my voice was starting to get very, very soft, very weak, very tired," she said. "It was when the drought was happening and there were lots of bushfires, smoke and dust and I thought that's what was causing it. "But that winter I'd had a doctor who said taking zinc was good for preventing respiratory disease - I wanted to choose the best and so I bought Blackmores Bio Zinc, but what I didn't realise was that it had 50mg of B6 in it." "I was popping these things every day, and I can see now that my symptoms - like headaches and migraines and gut pain and constipation were adding up, and by September my voice had become really weak and strained. "I just thought it was the dust and the bushfires and I just kept taking the B6, and then I'd lost my voice completely and had to give up work." As COVID hit, she was diagnosed with a completely paralysed left vocal cord, but was left without medical support. She began experiencing cramps, and started taking another supplement called Super Magnesium. "It also had 50 mg of B6 and, because I was getting all these migraines and I was pretty stressed because I'd lost my job and the whole COVID crap was starting, I was also taking Blackmores Executive Stress, which had another 25 milligrams of B6," Ms Thompson said. "At one stage that I was taking 125mg per day of B6, and just feeling worse and worse and worse." Years and many more appointments on, in September 2024, Ms Thompson saw a warning on the Therapeutic Goods Administration that made her suspect that her vitamins may have been poisoning her. She stopped taking them. "Magically, the gut pain, the constipation, the food intolerances all just disappeared within a couple of months," she said. "The anxiety lifted, the migraines eased off, the twitching and all that stuff just disappeared." "I've still got a base level of numb hands and feet, my voice hasn't improved and the fatigue hasn't improved. The weight loss and the muscle wasting has, in fact, got worse. "So I still can't work because I'm so fatigued and my voice is pretty crappy." In January, B6 poisoning hit the news, with the ABC's 730 running a report featuring patients who had similar symptoms and experiences to Ms Thompson. "I recognised my story and I just went, 'oh God, that's it'," she said. "I went back through all my diaries, 10 years of diaries, with orange highlighter and calculated all the B6 and just went, 'Oh my God'." Then, armed with a print-out of an Illawarra Mercury -an ACM mastheadarticle on the issue, in which Fairy Meadow, Wollongong, GP Kate McCullough issued a warning about high doses of the vitamin, she managed to convince her doctor to run a test. She has since been diagnosed with "B6 hypervitaminosis", and in recent months registered her interest in Polaris' proposed class action, which she hopes might stop others from going through her ordeal. Already the law firm says its has received more than 900 inquiries about the class action. "I just remember at one point, my doctor said, 'oh gee, Penny, I hate to think we're missing something'," Ms Thompson said. "Of course, I'd given him all the big lists of all the supplements I was taking, but he didn't know anything about it. None of the specialists knew about it." "Despite all the media coverage this year, and repeated alerts from the TGA, most doctors and allied health professionals are still completely unaware of B6 toxicity, how serious the resulting symptoms can be and how widespread it is becoming. "I'm really hoping the class action will generate enough publicity to turn this issue around." "And I'm hoping that this kicks up so much of a stink that all of these vitamin companies and the energy drink companies and the processed food manufacturers, they all stop putting more than the recommended daily dose into their products. "I want everybody to know about it, so every doctor in Australia knows about it and we can stop the tide of this epidemic of poisoning." A Blackmores spokesperson said it had received no formal legal claim, but was aware of reports about the class action. Penny Thompson spent nearly 13 years and thousands of dollars trying to get a diagnosis for her "mystery illness", which paralysed her vocal cords, damaged her nerves and left her unable to work, socialise or study. Finally, last year, with a litany of specialists left scratching their heads, the NSW Illawarra region woman began to suspect that the very things she had been using to ease her symptoms were actually poisoning her. Now, grieving and overwhelmed by all she has lost over more than a decade, Ms Thompson, 61, of Wollongong, south of Sydney, has registered her interest in a class action against supplement giant Blackmores, as health practitioners and patients begin to realise the extent of vitamin B6 poisoning. "Before this happened, I was a bloody fitness instructor and now I struggle to work," she said. "I haven't been out socially at night for 10 years. I can't drive for more than 20 minutes. I can't go travelling, I can't go bushwalking. "I struggle to work in my garden at home and it took me nine-and-a-half years to complete a three year university degree. "I just feel overwhelmed, I get angry, I get full of grief for all I've lost." In recent months, there have been growing reports of toxicity related to vitamin B6, which is naturally found in meat, fruit and vegetables but which is also now added to many vitamin supplements, shakes and energy drinks and is present in thousands of products on the Australian market.. According to the Therapeutic Goods Administration, taking too much can cause nerve damage, which many people experience as peripheral neuropathy - or numbness and tingling in the fingers and toes. After an increase in reports about this condition, the regulator recently recommended stricter regulations and stronger warnings. It has also noted that there is no consensus on a safe level of B6. In May, Melbourne's Polaris Lawyers announced it was pursuing a class action investigation against Blackmores, on behalf of anyone who has suffered injuries after taking its supplements "containing higher than recommended levels of vitamin B6". A Blackmores spokesperson said the company was committed to the highest standards of product quality and consumer safety. "All our products, including those containing vitamin B6, are developed in strict accordance with the regulatory requirements of the Therapeutic Goods Administration (TGA)," they said. They said the company would "ensure full compliance" with any changes the regulator makes. Ms Thompson's health struggles began back in 2012, when she went to the GP complaining of numbness in her hands and feet. She had recently moved back to Australia, and was busy and tired working three jobs and buying a house, so started taking vitamin supplements "to give me energy". "I just didn't feel right and my hands and feet were a bit numb but my GP said it was my age, or probably menopause," she said. "I said, 'I've seemed to lose weight', and he just went, 'fancy a woman in her 40s complaining of losing weight, ha ha ha', so I just left it." "But I was getting more and more fatigued and so, in 2013, I started keeping a really detailed health diary because I thought maybe I had a food allergy because I thought I was being poisoned." That kicked off a "pretty expensive" 10-year journey of seeing specialists, including neurologists, ENT doctors, cardiologists, pain specialists, rheumatologists and having nerve conduction studies or tests for heavy metals poisoning. "I was always very thorough when I saw them, because I was studying science, and I was keeping these diaries and they'd always ask you on the new patient form, please list all your medications, prescription and non-prescription so I'd write this huge list of stuff down, but none of them said anything." By late 2019, when she was working as an English teacher at TAFE, she noticed her voice changing. "I was working about three days a week and I just noticed that my voice was starting to get very, very soft, very weak, very tired," she said. "It was when the drought was happening and there were lots of bushfires, smoke and dust and I thought that's what was causing it. "But that winter I'd had a doctor who said taking zinc was good for preventing respiratory disease - I wanted to choose the best and so I bought Blackmores Bio Zinc, but what I didn't realise was that it had 50mg of B6 in it." "I was popping these things every day, and I can see now that my symptoms - like headaches and migraines and gut pain and constipation were adding up, and by September my voice had become really weak and strained. "I just thought it was the dust and the bushfires and I just kept taking the B6, and then I'd lost my voice completely and had to give up work." As COVID hit, she was diagnosed with a completely paralysed left vocal cord, but was left without medical support. She began experiencing cramps, and started taking another supplement called Super Magnesium. "It also had 50 mg of B6 and, because I was getting all these migraines and I was pretty stressed because I'd lost my job and the whole COVID crap was starting, I was also taking Blackmores Executive Stress, which had another 25 milligrams of B6," Ms Thompson said. "At one stage that I was taking 125mg per day of B6, and just feeling worse and worse and worse." Years and many more appointments on, in September 2024, Ms Thompson saw a warning on the Therapeutic Goods Administration that made her suspect that her vitamins may have been poisoning her. She stopped taking them. "Magically, the gut pain, the constipation, the food intolerances all just disappeared within a couple of months," she said. "The anxiety lifted, the migraines eased off, the twitching and all that stuff just disappeared." "I've still got a base level of numb hands and feet, my voice hasn't improved and the fatigue hasn't improved. The weight loss and the muscle wasting has, in fact, got worse. "So I still can't work because I'm so fatigued and my voice is pretty crappy." In January, B6 poisoning hit the news, with the ABC's 730 running a report featuring patients who had similar symptoms and experiences to Ms Thompson. "I recognised my story and I just went, 'oh God, that's it'," she said. "I went back through all my diaries, 10 years of diaries, with orange highlighter and calculated all the B6 and just went, 'Oh my God'." Then, armed with a print-out of an Illawarra Mercury -an ACM mastheadarticle on the issue, in which Fairy Meadow, Wollongong, GP Kate McCullough issued a warning about high doses of the vitamin, she managed to convince her doctor to run a test. She has since been diagnosed with "B6 hypervitaminosis", and in recent months registered her interest in Polaris' proposed class action, which she hopes might stop others from going through her ordeal. Already the law firm says its has received more than 900 inquiries about the class action. "I just remember at one point, my doctor said, 'oh gee, Penny, I hate to think we're missing something'," Ms Thompson said. "Of course, I'd given him all the big lists of all the supplements I was taking, but he didn't know anything about it. None of the specialists knew about it." "Despite all the media coverage this year, and repeated alerts from the TGA, most doctors and allied health professionals are still completely unaware of B6 toxicity, how serious the resulting symptoms can be and how widespread it is becoming. "I'm really hoping the class action will generate enough publicity to turn this issue around." "And I'm hoping that this kicks up so much of a stink that all of these vitamin companies and the energy drink companies and the processed food manufacturers, they all stop putting more than the recommended daily dose into their products. "I want everybody to know about it, so every doctor in Australia knows about it and we can stop the tide of this epidemic of poisoning." A Blackmores spokesperson said it had received no formal legal claim, but was aware of reports about the class action. Penny Thompson spent nearly 13 years and thousands of dollars trying to get a diagnosis for her "mystery illness", which paralysed her vocal cords, damaged her nerves and left her unable to work, socialise or study. Finally, last year, with a litany of specialists left scratching their heads, the NSW Illawarra region woman began to suspect that the very things she had been using to ease her symptoms were actually poisoning her. Now, grieving and overwhelmed by all she has lost over more than a decade, Ms Thompson, 61, of Wollongong, south of Sydney, has registered her interest in a class action against supplement giant Blackmores, as health practitioners and patients begin to realise the extent of vitamin B6 poisoning. "Before this happened, I was a bloody fitness instructor and now I struggle to work," she said. "I haven't been out socially at night for 10 years. I can't drive for more than 20 minutes. I can't go travelling, I can't go bushwalking. "I struggle to work in my garden at home and it took me nine-and-a-half years to complete a three year university degree. "I just feel overwhelmed, I get angry, I get full of grief for all I've lost." In recent months, there have been growing reports of toxicity related to vitamin B6, which is naturally found in meat, fruit and vegetables but which is also now added to many vitamin supplements, shakes and energy drinks and is present in thousands of products on the Australian market.. According to the Therapeutic Goods Administration, taking too much can cause nerve damage, which many people experience as peripheral neuropathy - or numbness and tingling in the fingers and toes. After an increase in reports about this condition, the regulator recently recommended stricter regulations and stronger warnings. It has also noted that there is no consensus on a safe level of B6. In May, Melbourne's Polaris Lawyers announced it was pursuing a class action investigation against Blackmores, on behalf of anyone who has suffered injuries after taking its supplements "containing higher than recommended levels of vitamin B6". A Blackmores spokesperson said the company was committed to the highest standards of product quality and consumer safety. "All our products, including those containing vitamin B6, are developed in strict accordance with the regulatory requirements of the Therapeutic Goods Administration (TGA)," they said. They said the company would "ensure full compliance" with any changes the regulator makes. Ms Thompson's health struggles began back in 2012, when she went to the GP complaining of numbness in her hands and feet. She had recently moved back to Australia, and was busy and tired working three jobs and buying a house, so started taking vitamin supplements "to give me energy". "I just didn't feel right and my hands and feet were a bit numb but my GP said it was my age, or probably menopause," she said. "I said, 'I've seemed to lose weight', and he just went, 'fancy a woman in her 40s complaining of losing weight, ha ha ha', so I just left it." "But I was getting more and more fatigued and so, in 2013, I started keeping a really detailed health diary because I thought maybe I had a food allergy because I thought I was being poisoned." That kicked off a "pretty expensive" 10-year journey of seeing specialists, including neurologists, ENT doctors, cardiologists, pain specialists, rheumatologists and having nerve conduction studies or tests for heavy metals poisoning. "I was always very thorough when I saw them, because I was studying science, and I was keeping these diaries and they'd always ask you on the new patient form, please list all your medications, prescription and non-prescription so I'd write this huge list of stuff down, but none of them said anything." By late 2019, when she was working as an English teacher at TAFE, she noticed her voice changing. "I was working about three days a week and I just noticed that my voice was starting to get very, very soft, very weak, very tired," she said. "It was when the drought was happening and there were lots of bushfires, smoke and dust and I thought that's what was causing it. "But that winter I'd had a doctor who said taking zinc was good for preventing respiratory disease - I wanted to choose the best and so I bought Blackmores Bio Zinc, but what I didn't realise was that it had 50mg of B6 in it." "I was popping these things every day, and I can see now that my symptoms - like headaches and migraines and gut pain and constipation were adding up, and by September my voice had become really weak and strained. "I just thought it was the dust and the bushfires and I just kept taking the B6, and then I'd lost my voice completely and had to give up work." As COVID hit, she was diagnosed with a completely paralysed left vocal cord, but was left without medical support. She began experiencing cramps, and started taking another supplement called Super Magnesium. "It also had 50 mg of B6 and, because I was getting all these migraines and I was pretty stressed because I'd lost my job and the whole COVID crap was starting, I was also taking Blackmores Executive Stress, which had another 25 milligrams of B6," Ms Thompson said. "At one stage that I was taking 125mg per day of B6, and just feeling worse and worse and worse." Years and many more appointments on, in September 2024, Ms Thompson saw a warning on the Therapeutic Goods Administration that made her suspect that her vitamins may have been poisoning her. She stopped taking them. "Magically, the gut pain, the constipation, the food intolerances all just disappeared within a couple of months," she said. "The anxiety lifted, the migraines eased off, the twitching and all that stuff just disappeared." "I've still got a base level of numb hands and feet, my voice hasn't improved and the fatigue hasn't improved. The weight loss and the muscle wasting has, in fact, got worse. "So I still can't work because I'm so fatigued and my voice is pretty crappy." In January, B6 poisoning hit the news, with the ABC's 730 running a report featuring patients who had similar symptoms and experiences to Ms Thompson. "I recognised my story and I just went, 'oh God, that's it'," she said. "I went back through all my diaries, 10 years of diaries, with orange highlighter and calculated all the B6 and just went, 'Oh my God'." Then, armed with a print-out of an Illawarra Mercury -an ACM mastheadarticle on the issue, in which Fairy Meadow, Wollongong, GP Kate McCullough issued a warning about high doses of the vitamin, she managed to convince her doctor to run a test. She has since been diagnosed with "B6 hypervitaminosis", and in recent months registered her interest in Polaris' proposed class action, which she hopes might stop others from going through her ordeal. Already the law firm says its has received more than 900 inquiries about the class action. "I just remember at one point, my doctor said, 'oh gee, Penny, I hate to think we're missing something'," Ms Thompson said. "Of course, I'd given him all the big lists of all the supplements I was taking, but he didn't know anything about it. None of the specialists knew about it." "Despite all the media coverage this year, and repeated alerts from the TGA, most doctors and allied health professionals are still completely unaware of B6 toxicity, how serious the resulting symptoms can be and how widespread it is becoming. "I'm really hoping the class action will generate enough publicity to turn this issue around." "And I'm hoping that this kicks up so much of a stink that all of these vitamin companies and the energy drink companies and the processed food manufacturers, they all stop putting more than the recommended daily dose into their products. "I want everybody to know about it, so every doctor in Australia knows about it and we can stop the tide of this epidemic of poisoning." A Blackmores spokesperson said it had received no formal legal claim, but was aware of reports about the class action.
The Australian
2 days ago
- 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
2 days ago
- 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
