Latest news with #TGA
ABC News
15 hours ago
- Health
- ABC News
Australia's TGA issues interim report to remove supplements high in B6 from shelves as toxicity cases rise
Major changes have been proposed to restrict access to a common over-the-counter vitamin, linked to a growing number of poisoning cases. Vitamin B6 — often listed as pyridoxine, pyridoxal, pyridoxamine — is present in thousands of products in Australia as an additive, including medicines, multivitamin and mineral supplements, energy drinks and weight loss shakes. 174 reports of peripheral neuropathy, peripheral sensory neuropathy, small fibre neuropathy or chronic polyneuropathy for products containing B6 have been reported to the medicines' regulator, the Therapeutic Goods Administration (TGA), though medical practitioners predict the true number is significantly higher. "While most of them have no side effects, if you are taking large doses of B6 your risk of peripheral neuropathy goes up." "We know that reported cases of peripheral neuropathy are a massive underestimate of the problem in the community, because so many people are unaware that that vitamins can cause these symptoms." In a new development to improve public safety, several recommendations have been handed down in a report penned by a senior TGA medical officer known as 'the delegate'. Called the 'Interim Decision', the report acts on the advice of the government's Advisory Committee on Medicines Scheduling. Most notably, it calls for the TGA to reclassify supplements containing more than 50mg of B6 as Schedule 3 (Pharmacist Only), by February 2027. The move would affect around 100 products, requiring pharmacists to first speak with consumers before approving a purchase. "Currently, preparations providing up to 200 mg of [B6] ... are available for self-selection without any professional guidance or oversight," the report states, adding "almost 80 per cent of these products provide a dose of more than 2 mg/day, which is above the RDI for pyridoxine, pyridoxal or pyridoxamine. "The daily requirement of vitamin B6 can be easily obtained from the usual Australian diet, and the use of supplemental vitamin B6 provides limited benefit except in people who have a clinically diagnosed vitamin B6 deficiency. A TGA spokesperson told 7.30 the decision, if implemented, "will reduce the maximum amount of vitamin B6 allowed in oral products than currently available for general sale". "The interim decision balances the risks and benefits of using vitamin B6 including the risk of peripheral neuropathy, acknowledging its potential for irreversible harm at higher doses and variability in individual metabolism," the spokesperson said. But, as detailed in the report, the proposed changes only account for around seven per cent of supplements containing B6 — there are more than 1,500 vitamins listed on the Australian Register of Therapeutic Goods, the majority of which are unscheduled and available over the counter. The report also recommended supplements exceeding 200mg should be reclassified as prescription medicines or 'schedule 4'. "It's a good thing that pharmacists will be able to have a really good counselling session with a patient, to make sure the item they're taking doesn't interact with other medications," said Caroline Diamantis, vice-president of the Pharmaceutical Society of Australia. "People used to think that complimentary medicines were completely safe but the more we delve into it the more we understand they do have unwanted side-effects or interference with other medications," she told 7.30. The interim decision also recommends tightening labelling rules, calling for clearer identification of vitamin B6 on packaging and stronger warnings to help consumers avoid accidental overexposure. "Use of ingredient names in labelling is inconsistent and confusing for consumers … and not always described as vitamin B6," the report said. "Of concern is that there are several products on the market where the front of the label provides no indication that vitamin B6 is an ingredient." It suggested changing the language on warning labels to be more direct. "Excess consumption of vitamin B6 can cause nerve damage. Stop use and see a doctor if you experience tingling, burning or numbness," was a suggestion. The report also calls on the multi-billion-dollar complementary medicines sector to take greater responsibility for educating consumers and reducing the risk of vitamin B6 overexposure, noting current labelling places too much burden on consumers to calculate total B6 intake. "Estimating the total daily vitamin B6 intake … is likely to be beyond the health literacy capability of the typical consumer," it said. The CEO of Complementary Medicines Australia John O'Doherty told 7.30: "we'll be carefully reviewing the interim decision and the recommendations of the Advisory Committee on Medicines Scheduling." Mr O'Doherty argued adverse events relating to the use of vitamin B6 are "extremely rare". "Based on a comparison of sales data with the TGA's public Database of Adverse Events, the chance of a reaction is less than one in half a million — this is extremely rare," he said. However, previous 7.30 investigations have found dozens of Australians have had issues from B6 toxicity, with many only becoming aware of their illness after seeing our reports. The TGA delegate also warns the prevalence could be much higher. "The true rate of occurrence of an adverse event cannot be determined from spontaneous adverse event reporting systems due to both general under-reporting and a lack of usage data," its report read. "A low number of spontaneous adverse event reports cannot be considered evidence of the absence a safety issue." Mr O'Doherty however agreed with some of the labelling recommendations, telling 7.30 his organisation has "been calling on the TGA to implement changes that allow labels and advertising to use terminology and ingredient names that consumers better understand." "At CMA's request, this is now under internal review at the TGA", he said. Medical negligence lawyer Nick Mann said the interim decision is a "small step in the right direction" but argued the TGA "can and should" go further. Mr Mann told 7.30 his legal firm, Polaris, is pursuing a class action lawsuit against one of the largest companies in the complementary medicines industry, Blackmores, "as a matter of public interest and safety". "We continue to investigate the potential class action, and given the response, the support and the evidence that's been pouring in ... with over 140 people contacting us to date," Mr Mann said. "Each of them had heartbreaking stories about how their lives have been affected by B6 toxicity, and sadly, many of them continue to be affected long after ceasing supplements containing Vitamin B6. "We've also had at least 10 doctors contact us to tell us about their own experiences with B6, and to let us know that they have discovered B6 toxicity in several of their patients, after taking supplements containing higher than the RDI of the vitamin over weeks and months," he said. The interim decision recommends the changes be made by 1 February 2027 — offering an 18-month implementation period. Watch 7.30, Mondays to Thursdays 7:30pm on ABC iview and ABC TV Do you know more about this story? Get in touch with 7.30 here.
Perth Now
4 days ago
- Health
- Perth Now
The fake drugs flooding into Australia
Counterfeit drugs, including cosmetic injectables, weight-loss drugs, and ivermectin tablets, have been seized at Australia's borders, prompting a fresh round of safety alerts from the Therapeutic Goods Administration. The alerts follow the TGA detecting attempted imports of the counterfeit pharmaceuticals and instructing the Australian Border Force to seize and destroy any intercepted products. The seized products were packaged in professional-looking branding designed to mimic legitimate medications. Testing confirmed many of them contained incorrect doses of active ingredients. Among the haul were 'substandard' Fitaro-branded semaglutide syringes, an in-demand diabetes drug also used for weight loss that is experiencing a global shortage. Substandard Fitaro semaglutide pre-filled syringes have been stopped at the Australian border. TGA Credit: Supplied 'We have conducted testing on several Fitaro-branded pre-filled syringes labelled as containing semaglutide,' the TGA alert said. 'Laboratory analysis found the following dosage strengths contain less than the stated amount of the active pharmaceutical ingredient semaglutide.' The TGA has declared the syringes counterfeit and warned they may pose serious health risks. Also seized were counterfeit versions of Laroscorbine Platinum, a cosmetic injectable claiming to contain vitamin C and collagen. The products were labelled as if manufactured by Roche, a company that discontinued Laroscorbine production two decades ago. Roche ceased Laroscorbine production two decades ago. TGA Credit: Supplied 'While these products appear genuine, Roche has confirmed they no longer manufacture Laroscorbine, and this, along with any product identified as Roche branded Laroscorbine is not genuine,' the TGA said. The agency warned these fakes 'to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources using the lawful supply chain'. Packaging for the Laroscorbine counterfeit shows a 'Beware of Counterfeit' label. The border crackdown also uncovered new batches of counterfeit ivermectin, a drug that gained notoriety during the Covid-19 pandemic despite being widely discredited as a treatment for the virus. Products labelled Iverjohn-12 and Ivervid-12 have been flagged in alerts since 2021. 'We have tested a further two imported, unregistered ivermectin products and found they are counterfeit under the Therapeutic Goods Act 1989,' the TGA said. 'As with the previous warnings issued, these products were purchased online from an overseas website and were not bought from an Australian pharmacy.' Imports of counterfeit ivermectin have been ongoing since they were first detected in 2021. Picture TGA Credit: Supplied The TGA is urging all consumers to immediately stop using these products and take any remaining doses to a local pharmacy for safe disposal. Anyone concerned about side effects should consult a doctor. The TGA is warning consumers to be extremely cautious when purchasing medicines online, noting that products bought from overseas websites may be counterfeit, contain hidden or harmful ingredients, and often fail to meet Australian standards for safety, quality, and effectiveness. Counterfeit drugs cannot be imported under the Personal Importation Scheme, and knowingly importing or distributing them is illegal.
News.com.au
4 days ago
- Health
- News.com.au
Warning over ‘genuine' looking drugs caught at border
Counterfeit drugs, including cosmetic injectables, weight-loss drugs, and ivermectin tablets, have been seized at Australia's borders, prompting a fresh round of safety alerts from the Therapeutic Goods Administration. The alerts follow the TGA detecting attempted imports of the counterfeit pharmaceuticals and instructing the Australian Border Force to seize and destroy any intercepted products. The seized products were packaged in professional-looking branding designed to mimic legitimate medications. Testing confirmed many of them contained incorrect doses of active ingredients. Among the haul were 'substandard' Fitaro-branded semaglutide syringes, an in-demand diabetes drug also used for weight loss that is experiencing a global shortage. 'We have conducted testing on several Fitaro-branded pre-filled syringes labelled as containing semaglutide,' the TGA alert said. 'Laboratory analysis found the following dosage strengths contain less than the stated amount of the active pharmaceutical ingredient semaglutide.' The TGA has declared the syringes counterfeit and warned they may pose serious health risks. Also seized were counterfeit versions of Laroscorbine Platinum, a cosmetic injectable claiming to contain vitamin C and collagen. The products were labelled as if manufactured by Roche, a company that discontinued Laroscorbine production two decades ago. 'While these products appear genuine, Roche has confirmed they no longer manufacture Laroscorbine, and this, along with any product identified as Roche branded Laroscorbine is not genuine,' the TGA said. The agency warned these fakes 'to the untrained eye, may appear legitimate, highlighting the need to purchase your medicines from legitimate sources using the lawful supply chain'. Packaging for the Laroscorbine counterfeit shows a 'Beware of Counterfeit' label. The border crackdown also uncovered new batches of counterfeit ivermectin, a drug that gained notoriety during the Covid-19 pandemic despite being widely discredited as a treatment for the virus. Products labelled Iverjohn-12 and Ivervid-12 have been flagged in alerts since 2021. 'We have tested a further two imported, unregistered ivermectin products and found they are counterfeit under the Therapeutic Goods Act 1989,' the TGA said. 'As with the previous warnings issued, these products were purchased online from an overseas website and were not bought from an Australian pharmacy.' The TGA is urging all consumers to immediately stop using these products and take any remaining doses to a local pharmacy for safe disposal. Anyone concerned about side effects should consult a doctor. The TGA is warning consumers to be extremely cautious when purchasing medicines online, noting that products bought from overseas websites may be counterfeit, contain hidden or harmful ingredients, and often fail to meet Australian standards for safety, quality, and effectiveness. Counterfeit drugs cannot be imported under the Personal Importation Scheme, and knowingly importing or distributing them is illegal.
Sydney Morning Herald
5 days ago
- Health
- Sydney Morning Herald
Mia Freedman's Mamamia and News Corp sued over cannabis ads
Mia Freedman's media company Mamamia and News Corp's magazine division are being sued by the therapeutic goods federal watchdog, accused of unlawfully advertising medicinal cannabis. The case, brought by the Therapeutic Goods Administration (TGA) in the Federal Court, alleges Mamamia and the News Corp Australia-owned publisher of Body + Soul magazine ran articles unlawfully promoting medicinal cannabis products from alternative-medicine website and dispensary Atlus in 2022 and 2023 following a marketing campaign. Mamamia and Body + Soul published articles promoting medicinal cannabis and Atlus, which included endorsements from medical professionals, who are banned from endorsing such products under the TGA's advertising code, the body said. The TGA referred to quotes from a nurse in Mamamia's article titled '[Name] takes CBD oil daily for her anxiety. Here's what she wants people to know', and a doctor in an article, '5 health conditions you didn't know medical cannabis could help with' published by Body + Soul. The latter also contained a link to the Atlus website, the TGA said. The Mamamia article was also allegedly written by a person whose mother worked for a company associated with Atlus and was also involved in creating the Atlus' marketing campaign. The article was also posted on Mamamia's Facebook page, which had 1.3 million followers as of June 23, 2025. AG Therapeutics, which operates online medical cannabis clinic Atlus is at the centre of the case. The company's sole director, Dr Shimal Jobanputra, was a respondent, and facilitated the preparation and approval of the advertising campaign, the TGA said. Jobanputra was previously listed as a general practitioner in a Sunshine Coast clinic. Atlus used euphemisms such as 'plant medicine' in widespread advertising online and on social media for medicinal cannabis, as well as promoting cannabis' use for serious health conditions, the TGA alleged. Both publications' articles also used terms such as 'medical marijuana', 'cannabinoids', 'plant-based therapies' and 'natural therapies' that 'target the endocannabinoid system'. 'Such claims, known as restricted or prohibited representations, are strictly regulated and generally forbidden in therapeutic goods advertising without explicit TGA approval,' a statement from the regulator said.
The Age
5 days ago
- Health
- The Age
Mia Freedman's Mamamia and News Corp sued over cannabis ads
Mia Freedman's media company Mamamia and News Corp's magazine division are being sued by the therapeutic goods federal watchdog, accused of unlawfully advertising medicinal cannabis. The case, brought by the Therapeutic Goods Administration (TGA) in the Federal Court, alleges Mamamia and the News Corp Australia-owned publisher of Body + Soul magazine ran articles unlawfully promoting medicinal cannabis products from alternative-medicine website and dispensary Atlus in 2022 and 2023 following a marketing campaign. Mamamia and Body + Soul published articles promoting medicinal cannabis and Atlus, which included endorsements from medical professionals, who are banned from endorsing such products under the TGA's advertising code, the body said. The TGA referred to quotes from a nurse in Mamamia's article titled '[Name] takes CBD oil daily for her anxiety. Here's what she wants people to know', and a doctor in an article, '5 health conditions you didn't know medical cannabis could help with' published by Body + Soul. The latter also contained a link to the Atlus website, the TGA said. The Mamamia article was also allegedly written by a person whose mother worked for a company associated with Atlus and was also involved in creating the Atlus' marketing campaign. The article was also posted on Mamamia's Facebook page, which had 1.3 million followers as of June 23, 2025. AG Therapeutics, which operates online medical cannabis clinic Atlus is at the centre of the case. The company's sole director, Dr Shimal Jobanputra, was a respondent, and facilitated the preparation and approval of the advertising campaign, the TGA said. Jobanputra was previously listed as a general practitioner in a Sunshine Coast clinic. Atlus used euphemisms such as 'plant medicine' in widespread advertising online and on social media for medicinal cannabis, as well as promoting cannabis' use for serious health conditions, the TGA alleged. Both publications' articles also used terms such as 'medical marijuana', 'cannabinoids', 'plant-based therapies' and 'natural therapies' that 'target the endocannabinoid system'. 'Such claims, known as restricted or prohibited representations, are strictly regulated and generally forbidden in therapeutic goods advertising without explicit TGA approval,' a statement from the regulator said.
