Latest news with #VitaminB6
Perth Now
a day ago
- Health
- Perth Now
‘Toxic' claim against supplement giant
Australian supplement giant Blackmores is facing potential class-action lawsuit, over claims that excessive levels of vitamin B6 in some of the company's over-the-counter products have led to serious health complications. Dominic Noonan-O'Keeffe began taking Blackmores supplements in May 2023 to support his health, ahead of the birth of his first child. Unaware the magnesium product contained potentially 'toxic' levels of vitamin B6, he claims he soon developed severe symptoms – including fatigue, headaches, muscle spasms, heart palpitations, and loss of sensation, according to Polaris lawyers. Doctors later diagnosed him with neuropathy linked to excessive B6 intake. Despite stopping in early 2024, Mr Noonan-O'Keeffe claims he continues to suffer daily from nerve pain and other symptoms. Polaris Lawyers – who are representing Mr Noonan-O'Keeffe, the lead plaintiff in the potential class-action – allege they later discovered the magnesium product contained about 29 times the recommended daily intake of vitamin B6. Mr Noonan-O'Keeffe claims he suffered lasting health impacts after taking Blackmores Magnesium+. Supplied Credit: Supplied Polaris Lawyers is now investigating a proposed class action against Blackmores for the excessive B6 levels in their vitamin supplements. 'It's alarming to walk down the vitamin aisle of any chemist in Australia and see vitamin supplements containing levels of B6 which are far and above the recommended daily intake,' Polaris Lawyers Founder and Principal Nick Mann said. 'What happened to Dominic is tragic, but he is not alone – we are aware of reports that excessive levels of B6 in over-the-counter supplements may have caused lasting injuries to hundreds of Australians. 'Polaris Lawyers is currently investigating a class action on behalf of anyone who has suffered injuries as a result of excessive levels of B6 as a result of taking Blackmores vitamin supplements.' Blackmores is one of the country's biggest supplement providers. Supplied Credit: Supplied In an interim decision report released in June, the TGA acknowledged no clear consensus on a safe vitamin B6 level that fully prevents peripheral neuropathy. The decision proposed rescheduling products containing over 50mg per day as 'Pharmacist Only Medicines.' A Blackmores spokesperson said they were aware of the TGA's proposed changes. 'At Blackmores, we are 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),' the spokesperson said. 'This includes compliance with maximum permitted daily doses and the inclusion of mandated warning statements. 'We acknowledge the interim decision issued by the TGA and we will ensure full compliance with its final determination.'
Time of India
08-07-2025
- Health
- Time of India
Health benefits of Vitamin B6 for your body and how to avoid deficiency
Vitamin B6, also known as pyridoxine, is a small but mighty nutrient your body depends on every day. It plays a key role in keeping your brain sharp, your mood balanced, and your immune system strong. Found in everyday foods like bananas, potatoes, chicken, and chickpeas, Vitamin B6 helps turn food into energy and supports the production of important brain chemicals like serotonin and dopamine. While most people get enough through a balanced diet, some may fall short without realizing it. Adequate Vitamin B6 intake can help alleviate symptoms of fatigue and depression. Ensuring sufficient levels is essential for overall well-being. Role of Vitamin B6 in our body Vitamin B6 is a vital nutrient that plays a role in over 100 enzyme reactions, supporting various bodily functions. As per MayoClinic, its key roles include: Metabolising proteins, fats, and carbohydrates for energy Supporting immune system function Fostering brain development during pregnancy and infancy Creating neurotransmitters like serotonin and dopamine Producing hemoglobin for oxygen transport in red blood cells Benefits of Vitamin B6 MedicalNewsToday lists out the benefits of Vitamin B6: Brain function: Helps create neurotransmitters and regulates energy use in the brain, with possible links to improved memory and cognitive function. Nausea during pregnancy: May alleviate mild to moderate symptoms of nausea and vomiting, with the American Congress of Obstetricians and Gynecologists (ACOG) recommending it as a safe treatment. Protection from air pollution: May help protect against the harmful effects of air pollution by reducing its impact on the epigenome, potentially leading to new preventive measures. Is Vitamin B6 deficiency common among people? According to NIH, Vitamin B6 deficiency rarely occurs alone and is often linked to low levels of other B vitamins, such as vitamin B12 and folic acid. As the deficiency worsens, biochemical changes become more noticeable. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like An engineer reveals: One simple trick to get internet without a subscription Techno Mag Learn More Undo Signs and symptoms of Vitamin B6 deficiency MedicalNewsToday lists out the signs and symptoms of Vitamin B6 deficiency: Tingling, numbness, and pain in hands and feet Anemia Seizures Depression Confusion Weekend immune system In rare cases, a severe deficiency can lead to a pellagra-like syndrome, characterized by: Seborrheic dermatitis Glossitis (inflammation of the tongue) Cheilosis (inflammation and cracking of the lips) People more prone to Vitamin B6 deficiency Certain individuals are more prone to Vitamin B6 deficiency, including: Those with liver, kidney, digestive, or autoimmune diseases Smokers Obese individuals Alcoholics Pregnant women Common causes of Vitamin B6 deficiency According to MedicalNewsToday, excessive alcohol consumption and certain medical conditions, such as hypothyroidism and diabetes, are common causes of Vitamin B6 deficiency Sources of Vitamin B6: With a balanced diet, most people can meet their Vitamin B6 needs, making deficiencies relatively uncommon. Vitamin B6's diverse functions make it essential for maintaining overall health and well-being. According to MedicalNewsToday, sources of Vitamin B6 are: Chickpeas (1 cup): 1.1 mg (65% DV) Beef liver (3 oz): 0.9 mg (53% DV) Yellowfin tuna (3 oz): 0.9 mg (53% DV) Chicken breast (3 oz): 0.5 mg (29% DV) Potatoes (1 cup): 0.4 mg (25% DV) Bananas (medium): 0.4 mg (25% DV) Other sources include: Fortified cereals Salmon Turkey Nuts Tofu Ground beef Spinach Squash Watermelon Taking supplements to cover Vitamin B6 deficiency Vitamin B6 is generally safe when consumed through food. However, according to MayoClinic, taking high doses of supplements can cause adverse effects, including: Ataxia (loss of muscle control or coordination) Painful skin lesions Heartburn and nausea Photosensitivity (sensitivity to sunlight) Numbness Reduced sensitivity to pain or extreme temperatures It's essential to be mindful of supplement dosages to avoid these potential side effects Also read | Post-cancer exercise plan lowers death and recurrence rates, according to a study
ABC News
02-07-2025
- Health
- ABC News
TGA concedes it failed to prevent growing number of blood toxicity cases attributed to Vitamin B6
Australia's medicines regulator has conceded its laws have failed to slow a growing number of blood toxicity cases attributed to a common over-the-counter vitamin. The Therapeutic Goods Administration (TGA) also admitted some associated effects — including irreversible nerve damage — are a bigger problem than the agency first realised. "The [legislation] changes from a few years ago, we've seen, were not sufficient to reduce the rate of the level of toxicity from B6," the department's chief medical advisor Professor Robyn Langham told 7.30. In its manufactured form Vitamin B6 — often labelled pyridoxine, pyridoxal, or pyridoxamine — is added to thousands of Australian products including foods, energy drinks, diet shakes and supplements. Overconsumption of the synthetic vitamin can cause life-altering issues including peripheral neuropathy, a nerve damage complication causing tingling, numbness, burning or weakness in limbs. "It's just shocking," said clinical pathologist Dr David Kanowski, who runs a clinic testing B6 blood samples from across Australia. "Sometimes we talk to doctors who think it's a clerical error because the toxicity results are so high, and we say, 'No it's real, you need to sort it out,'" he said. Dr Kanowski has noted a "massive" increase in the number of people coming forward for B6 blood tests; doubling since January to more than 10,000 each month. Looking at the data for May, he said 4.5 per cent, or 450 people, returned results showing they were "very likely" to develop a neuropathy. A quarter of the samples, or 2,500 people, would "possibly, but not probably" also be showing symptoms. "One big lot [of cases] was caused by magnesium supplements, and I think it was possibly added as filler," Dr Kanoski said. "I'm not sure the technical reasons why it was there." The TGA is responsible for approving the ingredients used in complementary medicines in Australia. B6 is registered in more than 1,500 over-the-counter supplements — from magnesium to multivitamins. Eighty per cent of them contain levels well above the recommended daily amount of 1.7mg. 7.30 asked Blackmores Group, one of Australia's biggest supplements manufacturers, why many of its products contain B6 in such high levels. The company declined an interview but said all its products "including those containing Vitamin B6, are developed in strict accordance with the regulatory requirements of the TGA". While its own interim report found "the benefits of supplemental intake of vitamin B6 to be negligible", the TGA now joins the list of organisations which could not or would not say why B6 is added to so many products. "I'm not really able to answer why the commercial decisions are made by the different sponsors," Professor Langham said. She was quick to defend the TGA's "regulatory frameworks" as "very robust". "They exist so that the safety of the Australian community is held right at the centre of everything that we do," she said. After months of pressure to act, the agency handed down several recommendations on Friday, based on the advice of a committee tasked to investigate the burgeoning B6 problem. It was critical of the complementary sector, describing product labelling as "inconsistent and confusing", and called for clearer information and the rescheduling of supplements containing more than 50 milligrams of the vitamin, which would move several products off shelves and behind counters. "That will give the Australian community more protection and a greater sense of safety," Professor Langham said. The TGA last tightened the rules around B6 in 2022, requiring supplement companies to put warnings on products with more than 10mg. But many sufferers and medical professionals say they didn't go far enough. And there are new concerns that the latest round of proposed changes won't prevent toxicity for people taking multiple supplements at once. "It could still easily be an overdose over a period of time, if you're taking three or four complementary medicines with lower dosages," community pharmacist Caroline Diamantis told 7.30. The complementary medicines sector argues that B6-related incidents are "extremely rare", according to Complementary Medicines Australia boss John O'Doherty, "based on a comparison of sales data with the TGA's public database". While that data shows more than 170 adverse events, the TGA's Professor Langham said it could not be used to make that case. "I think it's sufficient to say that our database of adverse events doesn't necessarily reflect the true incidence of what's happening in the community," she told 7.30. "It's also important to understand that because something is reported, it doesn't necessarily mean that there's a definite attribution of cause there." Ms Diamantis is also concerned the proposed implementation of the TGA's regulatory changes, February 2027, "is too far away". "Personally I feel like that's too long, because there's another year or more where people could still be experiencing side effects," she said. Professor Langham said the complexities of the changes means the process "is a long one". "We're going to have to look at reformulating their products, which will mean either transitioning them out of the market or reducing the dosage that's in there," she told 7.30. "And there's also another element of changes that the TGA is looking to make from a legal perspective to our legislation around some of the labelling and also around some of the lists of medicines, what we call our permissible ingredients list. "It's done so that things can be done carefully and properly, and so that Australians can feel confident, ultimately, that the correct decision is being made." The TGA will accept submissions on its "interim decision" until July 27 2025, which will be considered by a senior medical officer before a final decision is made. 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.
ABC News
02-07-2025
- Health
- ABC News
TGA concedes it failed to prevent growing number of blood toxicity cases linked to Vitamin B6
Earlier this year 7.30 reported on the little-known danger associated with a common vitamin, one that's added to thousands of products - from medicine to supplements and energy drinks. Now Australia's medicine regulator has conceded its laws failed to prevent a growing number of blood toxicity cases linked to Vitamin B6. 7.30's Tom Hartley reports.
ABC News
27-06-2025
- 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.
