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Yahoo
6 hours ago
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Sarepta Therapeutics Acknowledges CHMP Negative Opinion for ELEVIDYS in the European Union
Partner Roche will continue its dialogue with the European Medicines Agency to explore a potential path forward to make ELEVIDYS available to individuals living with Duchenne muscular dystrophy in the EU ELEVIDYS is the first and only disease-modifying gene therapy for Duchenne CAMBRIDGE, Mass., July 25, 2025--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, acknowledges that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the conditional marketing authorization (CMA) for ELEVIDYS (delandistrogene moxeparvovec) in ambulatory individuals ages three to seven years for the treatment of Duchenne muscular dystrophy (DMD). "While we are disappointed by the CHMP's negative opinion, we understand the urgent need for continued dialogue and collaboration to bring transformative therapies to people with Duchenne who live with a relentless disease that steals their mobility, independence and ultimately life – often by early adulthood," said Louise Rodino-Klapac, Ph.D., president of research & development and technical operations, Sarepta. "Following the initial FDA approval of ELEVIDYS on June 22, 2023, the therapy has subsequently received regulatory approval in several other countries. In the U.S., we are actively working with the FDA to address recent safety questions. We remain committed to working with regulators to address outstanding questions on safety so that people living with Duchenne have access to this important therapy." ELEVIDYS is the first and only approved gene therapy targeting the underlying cause of disease that has consistently demonstrated stabilization or slowing of DMD disease progression, with durable effects on functional and biological outcomes and muscle health. While the primary endpoint was not met in EMBARK after one year, ELEVIDYS showed clinically meaningful and statistically significant improvements across important secondary endpoints of functional outcome measures when compared to placebo. Longer term efficacy data were also submitted to EMA, including two-year results from the EMBARK study and three-year pooled efficacy analysis from three other ELEVIDYS studies that showed clinically meaningful improvements across key measures of motor function. One-year data from part one of the EMBARK study were published in Nature Medicine in October 2024, and results from year two were shared at this year's Muscular Dystrophy Association Clinical & Scientific Conference in Dallas. Quantitative muscle MR (magnetic resonance) outcomes from part 1 of EMBARK were published in JAMA Neurology in May 2025. Sarepta is responsible for regulatory approval and commercialization of ELEVIDYS in the U.S., as well as manufacturing. Roche is responsible for regulatory approvals and bringing ELEVIDYS to patients across the rest of the world. Regulatory approval and commercialization of ELEVIDYS in Japan is through Chugai Pharmaceuticals via its alliance with Roche. About ELEVIDYS (delandistrogene moxeparvovec-rokl)ELEVIDYS (delandistrogene moxeparvovec-rokl) is a single-dose, adeno-associated virus (AAV)-based gene transfer therapy for intravenous infusion designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene that codes for the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. ELEVIDYS is indicated in U.S. for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the DMD gene For patients who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval in the U.S. based on expression of ELEVIDYS micro-dystrophin (noted hereafter as "micro-dystrophin") in skeletal muscle. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). U.S. IMPORTANT SAFETY INFORMATION CONTRAINDICATION: ELEVIDYS is contraindicated in patients with any deletion in exon 8 and/or exon 9 in the DMD gene. WARNINGS AND PRECAUTIONS: Infusion-related Reactions: Infusion-related reactions, including hypersensitivity reactions and anaphylaxis, have occurred during or up to several hours following ELEVIDYS administration. Closely monitor patients during administration and for at least 3 hours after the end of infusion. If symptoms of infusion-related reactions occur, slow, or stop the infusion and give appropriate treatment. Once symptoms resolve, the infusion may be restarted at a lower rate. ELEVIDYS should be administered in a setting where treatment for infusion-related reactions is immediately available. Discontinue infusion for anaphylaxis. Acute Serious Liver Injury: Acute serious liver injury has been observed with ELEVIDYS, and administration may result in elevations of liver enzymes (such as GGT, GLDH, ALT, AST) or total bilirubin, typically seen within 8 weeks. Patients with preexisting liver impairment, chronic hepatic condition, or acute liver disease (e.g., acute hepatic viral infection) may be at higher risk of acute serious liver injury. Postpone ELEVIDYS administration in patients with acute liver disease until resolved or controlled. Prior to ELEVIDYS administration, perform liver enzyme test and monitor liver function (clinical exam, GGT, and total bilirubin) weekly for the first 3 months following ELEVIDYS infusion. Continue monitoring if clinically indicated, until results are unremarkable (normal clinical exam, GGT, and total bilirubin levels return to near baseline levels). Systemic corticosteroid treatment is recommended for patients before and after ELEVIDYS infusion. Adjust corticosteroid regimen when indicated. If acute serious liver injury is suspected, consultation with a specialist is recommended. Immune-mediated Myositis: In clinical trials, immune-mediated myositis has been observed approximately 1 month following ELEVIDYS infusion in patients with deletion mutations involving exon 8 and/or exon 9 in the DMD gene. Symptoms of severe muscle weakness, including dysphagia, dyspnea, and hypophonia, were observed. Limited data are available for ELEVIDYS treatment in patients with mutations in the DMD gene in exons 1 to 17 and/or exons 59 to 71. Patients with deletions in these regions may be at risk for a severe immune-mediated myositis reaction. Advise patients to contact a physician immediately if they experience any unexplained increased muscle pain, tenderness, or weakness, including dysphagia, dyspnea, or hypophonia, as these may be symptoms of myositis. Consider additional immunomodulatory treatment (immunosuppressants [e.g., calcineurin-inhibitor] in addition to corticosteroids) based on patient's clinical presentation and medical history if these symptoms occur. Myocarditis: Acute serious myocarditis and troponin-I elevations have been observed following ELEVIDYS infusion in clinical trials. If a patient experiences myocarditis, those with pre-existing left ventricle ejection fraction (LVEF) impairment may be at higher risk of adverse outcomes. Monitor troponin-I before ELEVIDYS infusion and weekly for the first month following infusion and continue monitoring if clinically indicated. More frequent monitoring may be warranted in the presence of cardiac symptoms, such as chest pain or shortness of breath. Advise patients to contact a physician immediately if they experience cardiac symptoms. Preexisting Immunity against AAVrh74: In AAV-vector based gene therapies, preexisting anti-AAV antibodies may impede transgene expression at desired therapeutic levels. Following treatment with ELEVIDYS, all patients developed anti-AAVrh74 antibodies. Perform baseline testing for presence of anti-AAVrh74 total binding antibodies prior to ELEVIDYS administration. ELEVIDYS administration is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers greater than or equal to 1:400. Adverse Reactions: The most common adverse reactions (incidence ≥5%) reported in clinical studies were vomiting, nausea, liver injury, pyrexia, and thrombocytopenia. Report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Sarepta Therapeutics at 1-888-SAREPTA (1-888-727-3782). For further information, please see the full Prescribing Information. About Sarepta TherapeuticsSarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (Duchenne) and limb-girdle muscular dystrophies (LGMDs) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. For more information, please visit or follow us on LinkedIn, X, Instagram and Facebook. Internet Posting of InformationWe routinely post information that may be important to investors in the 'For Investors' section of our website at We encourage investors and potential investors to consult our website regularly for important information about us. Forward-Looking StatementsThis statement contains "forward-looking statements." Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "will," "may," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, research and development programs, discussions with regulators and the prospects for approvals or continued approvals, as applicable, of ELEVIDYS and the potential benefits and risks of ELEVIDYS. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results; our products or product candidates may be perceived as insufficiently effective, unsafe or may result in unforeseen adverse events; our products or product candidates may cause undesirable side effects that result in significant negative consequences; the possible impact of regulatory decisions by, and any halts imposed by, regulatory agencies on our business; and those risks identified under the heading "Risk Factors" in our most recent Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company, which you are encouraged to review. Any of the foregoing risks could materially and adversely affect the Company's business, results of operations and the trading price of Sarepta's common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained herein. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law. Source: Sarepta Therapeutics, Inc. View source version on Contacts Investor Contact: Ian Estepan617-274-4052iestepan@ Media Contacts: Tracy Sorrentino617-301-8566tsorrentino@ Kara Hoeger617-710-3898KHoeger@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
7 hours ago
- Health
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EU regulator approves injectable HIV drug that experts say could help stop transmission
LONDON (AP) — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus' transmission. In a statement on Friday, the EU drug regulator said its evaluations of lenacapavir, sold as Yeytuo in Europe by Gilead Sciences, showed the drug is 'highly effective' and 'considered to be of major public health interest.' Once the regulator's guidance is accepted by the European Commission, the authorization is valid in all 27 EU member countries as well as Iceland, Norway and Liechtenstein. Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping transmission in both women and men. Winnie Byanyima, executive director of the U.N. AIDS agency, has said the drug 'could change the trajectory of the HIV epidemic' if it is made available to everyone who needs it. In June, the U.S. Food and Drug Administration authorized lenacapavir to prevent HIV. Earlier this month, the World Health Organization recommended countries offer the drug as an additional option to people at risk of the virus. Condoms help guard against HIV infection if used properly. Other medication aimed at preventing HIV include daily pills that people can take and another injectable drug called cabotegravir, which is given every two months. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more visits to health clinics or stigma from taking daily pills. Critics have raised concerns, however, that lenacapavir may not be made widely enough available to stop global outbreaks of HIV. Drugmaker Gilead has said it will allow cheap, generic versions to be sold in 120 poor countries with high HIV rates — mostly in Africa, Southeast Asia and the Caribbean. But it has excluded nearly all of Latin America, where rates are far lower but increasing, sparking concern the world is missing a critical opportunity to stop the disease. Last year, there were about 630,000 AIDS deaths worldwide and more than 40 million people are estimated to have HIV, according to UNAIDS. UNAIDS chief Byanyima has previously suggested the U.S. President Donald Trump make a deal with Gilead to produce and license its 'magical' prevention drug lenacapavir across the world to the millions of people who need it. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. The Associated Press
BBC News
2 days ago
- Health
- BBC News
Academic and devolution reformer Sir Kenneth Calman dies aged 83
Sir Kenneth Calman, the doctor and academic who led the Calman Commission review into devolution, has died aged a long career in medicine and public service, he served as chief medical officer for both Scotland and England, was warden and vice-chancellor of the University of Durham and chancellor of the University of 2009 he led the review of the Scottish Parliament which suggested extending Holyrood's death was announced by his daughter, the comedian Susan Calman. Sir Kenneth Calman was born in Glasgow in 1941 and educated at the city's Allan Glen's School and the University of worked in vascular and transplant surgery before being appointed Professor of Oncology at the University of Glasgow. Sir Kenneth became chief medical officer for Scotland in 1989, moving to the same role in England two years took up his post in Durham in 1998, serving for eight years before returning to lead the University of Glasgow from 2006 to Kenneth was knighted in 1996 and was a Deputy Lieutenant of Glasgow until his death. 'A horrific time' In an Instagram post his daughter Susan wrote: "It's a horrific time but I'm lucky to have supportive family, friends and a wonderful partner to hold me up. "Thanks to the incredible staff at the Queen Elizabeth Hospital in Glasgow for treating him with such kindness and dignity and for the compassion they showed us. It made the bleakest of times more bearable. "When he was conscious and alert I told him I loved him. He said 'you're wonderful' and I said 'so are you'. "Grief is so completely, overwhelmingly, physically painful, but as others have said such feelings are an indication of how loved he was, is and always will be." 'A really lovely person to work with' The review of devolution led by Sir Kenneth was commissioned by the Scottish Parliament in reported in 2009, making 24 recommendations to extend the parliament's powers, including into other tax-raising areas. It said Scotland should take charge of half the income tax it report, which included input from the three main Unionist parties but not the SNP, came five years before the Scottish independence referendum in September UK coalition government of 2010-2014 pledged to implement the findings and used them as the basis for the Scotland Act 2012. Sir Kenneth went on to chair the trustees of the National Trust for Scotland (NTS) and chaired the board of the National Library of Scotland (NLS) from 2016 to 2020.A statement released from the NLS said they were "very sad" to hear of his death."We remember him fondly as chair of the National Library of Scotland board," the statement said."We wouldn't be where we are today without his support and encouragement. "But most of all, he was a really lovely person to work with. "Our thoughts are with his family and his many friends." Prof Sir Kenneth Calman was the ideal choice to lead a review into Scottish diplomatic and with a kindly manner, his chairing skills were much eponymous commission stemmed from a political earthquake in SNP's victory in the Holyrood election that year lifted the lid on the independence question, beginning what was called a "national conversation".As the new party of government put a referendum on the agenda, the pro-union parties set out their something more had to be done and they talked about a "new agenda for Scotland".The Commission on Scottish Devolution was set up by the UK Labour government - and opposed by the the end of the day - and most significantly - tax-raising powers were eventually devolved to Holyrood as part of the commission's former medical man had carried out significant but gentle surgery on the body politic, despite the wider unionist-nationalist dividing Kenneth's commission helped pave the way for another - more significant - review of devolution in 2014, where the parties saw the advantages of cross-party co-operation.
Yahoo
4 days ago
- Health
- Yahoo
Precision Era to Redefine Treatment, Drive $450B Economic Investment and Change Lives Across Asia Pacific
SINGAPORE, July 22, 2025 /PRNewswire/ -- The Precision Era of medicine is arriving in Asia Pacific, driven by the arrival of a critical mass of innovative therapies that will redefine treatment, attract investment and improve lives, a new expert-driven report finds. Released today, 'On the Cusp of a Cure' White Paper examines Asia Pacific's readiness for the Precision Era – the current, transformative period where generically prescribed and regularly administered treatments are increasingly giving way to potentially curative therapies tailored to individuals and their disease. Treatments called precision therapies. Across the four markets over the next 10 years, the new research by L.E.K. Consulting and an advisory committee of 16 Asia Pacific experts using a proprietary 'whole system benefits modelling' approach found that the Precision Era has the potential to: Drive direct economic investment of approximately USD 450 billion.[i] Create almost 1.2 million highly skilled jobs[i] in R&D, advanced manufacturing and biotechnology. Drive USD1.615 trillion in broader[i], indirect economic benefit via a multiplier effect across adjacent industries. Save healthcare systems across the four markets USD 39 billion[i], alleviating intense pressure on resources. Increase workforce participation for 24 million patients and caregivers by improving their ability to return or stay in work.[i] "The Precision Era is being driven by the arrival of a critical mass of some 4,000 innovative cell and gene therapies that will redefine treatment, attract investment and improve lives. Never before have we had such a clear view of the huge potential that this new era holds for Asia-Pacific. Healthcare systems stand to save billions, and patients could potentially live healthier for longer. The broader economic impact of this new era medicine is equivalent to South Korea's annual GDP, and the potential for new jobs greater than the entire population of Adelaide," said Stephanie Newey, Managing Partner, Head of L.E.K. Consulting Australia. Precision therapies put us on the cusp of a cure The 'On the Cusp of a Cure' research assessed data from more than 1,000 clinical trials across four novel technologies – gene therapies, targeted antibody therapies, drug-device combination therapies, and diagnostic technologies. These precision therapies are considered part of the Precision Era because they provide enhanced health benefits through a more tailored approach, represent a paradigm shift to how care has been provided previously and are the focus of significant research and investment. Critically, some experts suggest we may be on the cusp of a cure for diseases that have previously been considered incurable and represent Asia-Pacific's most pressing health challenges, such as many cancers and genetic disorders. "Asia disproportionately carries the largest cancer and rare disease burden in the world. It shoulders nearly half of all global cancer incidence[ii] and is home to 258 million people who are living with rare diseases[iii]. Worse still, these numbers are only expected to grow, fuelling calls for sustainable, scalable and effective solutions. Precision therapies are stepping forward to meet this critical need and represent a new standard of care for many of Asia-Pacific's health challenges," said Professor Baorong Yu, from the University of International Business and Economics in China. One of the most groundbreaking examples of these treatments is chimeric antigen receptor T-cell (CAR-T) therapy that modifies the body's own T cells (a type of white blood cell) to target and destroy cancer cells[iv]. It is commonly used in the treatment of blood cancers, which has a 50% survival rate for over a third of patients. Currently, these patients are mostly treated through chemotherapy and radiotherapy, but many do not respond or will relapse. "With increased access to innovative treatments such as CAR-T therapy, particularly earlier in treatment regimes, patients could live longer with a better quality of life," said Naomi Sakurai, Advisory Committee member and Founder and CEO, Cancer Solutions. "Rather than going through multiple rounds of chemo, they would have a therapy tailored specifically to their condition. These precision treatments are now offering hope by potentially curing once-incurable diseases and giving people the priceless gift of more time with their loved ones." What's holding back the adoption of precision therapies? The Precision Era brings fundamental change to the way disease is approached and how patients are treated, and requires an equivalent rethink from regulators and policymakers. While each market has its own, unique policy environment, 'On the Cusp of a Cure' series found that Australia, China, Japan, and South Korea all exhibit similar barriers to precision therapy adoption. Rules remain unclear for evaluating the reimbursement of new precision therapies, there is limited awareness among patients and doctors about these treatments, and better healthcare infrastructure is needed to support access. The 'On the Cusp of a Cure' research presents a number of regional solutions to unlock the potential benefits of precision therapies: Establish streamlined regulatory and reimbursement pathways specifically tailored for these treatments Increase education for providers, patients, and the community to enhance understanding of the Precision Era Enhance public-private collaboration to foster innovation and equitable access to precision therapies. Improve access and affordability through pricing strategies, reimbursement frameworks, and insurance initiatives for treatments and diagnostics alike. Through clinical guidelines and knowledge sharing, empower HCPs to make informed decisions about precision therapies, and assist patients in complex treatment paths. By backing local industry investments in therapies and diagnostics, and nurturing expertise, joint efforts can drive sustainable progress towards transformative innovations. "With this new era of precision therapies, we stand at the threshold of transforming healthcare across Asia-Pacific," said Sakurai. "But for the full potential of these medicines to materialise, regulatory systems as well as knowledge and infrastructure must keep up. The goal of precision therapies is to ensure the right patient, right timing, right treatment and right dose. We all have a role to play, including policymakers, healthcare professionals, and healthcare industry leaders, to remove barriers for patients to these potentially life-changing therapies." "On the Cusp of a Cure White Paper Asia Pacific Series is made up of four local market white papers evaluating barriers to precision therapy adoption, providing recommendations for improvement, and assessing the value of widespread adoption in Australia, China, Japan, and Korea. Notes to Editor: On the Cusp of a Cure White Paper Series and Advisory Committee Members The On the Cusp of a Cure whitepaper series was supported by an advisory committee of 16 pre-eminent regional experts in precision medicine, economic and health policy, and patient experience across Australia, China, Japan and Korea. It was also sponsored by Johnson & Johnson. Australia China South Korea Japan David Thomas, Chief Scientific Officer, Omico Jaala Pulford, Chair of the Board, MTPConnect Christine Cockburn, CEO, Rare Cancers Australia Baorong Yu, Professor and market access key opinion leader, University of International Business and Economics Andy Mok, Head of China, Guardant Health Kevin Huang, Founder and president, China Organization for Rare Disorders (CORD) Caicun Zhou, Professor and lung cancer key opinion leader, School of Medicine, Tongji University Paul Lee, Former GM, Gilead Sciences Korea Jin-Ah Kim, Advocate for rare diseases, Seoul National University Hospital, Department of Genomic Medicine, Rare Disease Centre Prof Jeonghoon Ahn, Professor of Health Convergence, Ewha University Teruyuki Katori, Representative Director, Special Appointed Professor, Future Institute Wolong, General Incorporated Association Graduate School of Social Sciences, University of Hyogo Daisuke Sato, Professor. Fujita Health university Manabu Muto, Professor, Kyoto University Graduate School of Medicine Masahiro Miyake, Professor, Kyoto University Hospital Naomi Sakurai, Founder and CEO, Cancer Solutions Keisuke Shimizu, Leader, Lung cancer HER2 "HER HER" About L.E.K. Consulting We're L.E.K. Consulting, a global strategy consultancy working with business leaders to seize competitive advantage and amplify growth. Our insights are catalysts that reshape the trajectory of our clients' businesses, uncovering opportunities and empowering them to master their moments of truth. Since 1983, our worldwide practice — spanning the Americas, Europe, Middle East and Asia-Pacific — has guided leaders across all industries from global corporations to emerging entrepreneurial businesses and private equity investors. Looking for more? Visit [i] L.E.K Consulting. On the Cusp of a Cure 2025. [ii] Huang J, Ngai CH, Deng Y, Tin MS, Lok V, Zhang L, Yuan J, Xu W, Zheng ZJ, Wong MCS. Cancer Incidence and Mortality in Asian Countries: A Trend Analysis. Cancer Control. 2022 Jan-Dec;29:10732748221095955. doi: 10.1177/10732748221095955. PMID: 35770775; PMCID: PMC9252010. [iii] IQVIA. Rare Diseases in APAC: The Unmet Potential. Available from Accessed April 2025. [iv] American Cancer Society. CAR T-cell therapy and Its Side-effects. Available from View original content: SOURCE L.E.K Consulting
Yahoo
4 days ago
- Health
- Yahoo
B12 Supplements and IVs Promise an Energy Boost. Here's What the Science Says
B12, a vitamin naturally found in animal products, has become the internet's favorite solution to low energy, fatigue, and overall sluggishness. It's long made an appearance in multivitamins and standalone pills—but these days, its footprint seems to be ballooning. Energy drinks and shots are juiced up with the ingredient, as are IV drips promising things like vitality and hangover relief. And of course, a growing market of run-of-the-mill B12 tablets and gummies tout similar claims, suggesting the vitamin can give you an instant energy lift. But as with most supplements, marketing can be deceiving, and the truth about B12 isn't quite so 'easy pick-me-up' as you might (desperately) want to believe. B12 is indeed a critical vitamin to consume. It plays a key role in forming red blood cells (which shuttle oxygen to your organs) and helps convert food into energy, so it makes sense why people might associate it with getting a boost, Gary Soffer, MD, director of the Integrative Medicine Program at Yale School of Medicine, tells SELF. It also helps create new DNA molecules (which are necessary to repair cells and form new ones) and maintain healthy nerves (hence why B12 deficiency is linked with neuropathy and even cognitive decline). Plus, the body can't make it, so we have to get it from outside sources, like meat, fish, eggs, and dairy items. But at the same time, we don't need much B12 to reap its benefits—the recommended amount for adults is 2.4 micrograms daily, which most people in the US typically hit with food. So, are there benefits to taking a supplemental form of it? And how can you tell if you might actually be B12 deficient? Read on for everything you need to know about taking B12 and when, if ever, it may be something your doctor recommends. Spoiler alert: There's no evidence that suggests loading up on B12 will give you energy if you're not deficient. It's true that a lack of vitamin B12 in your system—less than around 150 picograms per milliliter of blood—could manifest as fatigue or weakness. (Though it's worth noting, B12 deficiency doesn't always trigger symptoms.) Without enough B12, you could wind up with larger-than-usual red blood cells that don't effectively transport oxygen to your organs, which is a form of anemia. Plus, low B12 levels could interfere with your body's typical process for churning out energy from food, which may contribute to lethargy. And it can eventually diminish the protective covering on your nerves, leading to neurological symptoms like numbness and tingling in your hands and feet, and mood changes. So if your doctor determines that you have a B12 deficiency, taking a B12 supplement could restore your energy and resolve other related symptoms. However, as few as 6% of people in the US under age 60 have a B12 deficiency. If you're like the majority of the population that is not substantially missing out on B12, consuming more than the recommended daily value isn't going to make any difference—no matter how fatigued you may be. After all, there are a bunch of non-B12-related causes for tiredness, ranging from stress, dehydration, and poor sleep habits to medical conditions like depression and hypothyroidism. 'It's the same reason why taking more iron when you're not iron-deficient isn't going to increase your energy, either,' Elisabeth Fowlie Mock, MD, MPH, a family physician in Bangor, Maine, and a member of the board of directors of the American Academy of Family Physicians, tells SELF. Not to mention, your body will just flush out any extra B12 in your pee. 'It works like a gas tank,' Dr. Soffer explains, 'so if you take more [than it needs], it'll just spill over.' Any boost you might feel from popping a B12 supplement is generally a placebo. When it comes to shots and energy drinks laden with the stuff, there's a greater chance that you're feeling buzzy in response to other ingredients like caffeine and sugar. And the instant refreshment of an IV drip is often tied simply to the rush of hydration. B12 deficiency is pretty rare, though a few GI disorders could make it more likely. Most people in the US get plenty of B12 via their diet. (A single serving of beef or Greek yogurt, or two large eggs can get you about halfway to the recommended daily value, and one serving of salmon or canned tuna is enough to surpass it.) So doctors don't generally suspect a B12 deficiency (at least, not off the bat) if someone comes to them with malaise or fatigue, Dr. Mock says, nor do they routinely check B12 levels with a blood test. That said, your doctor may be suspicious of deficiency if you report not only tiredness but also the neurological or cognitive symptoms noted above. Same goes if you're experiencing other symptoms of anemia like shortness of breath, dizziness, pale skin, and a fast heartbeat. Iron deficiency is a more likely culprit there, Dr. Mock says, but your doctor may still check your B12 level to be safe. The other scenario that may prompt them to assess B12 for low energy is if you have a risk factor for deficiency. A big one is being vegetarian or vegan. After all, B12 only occurs naturally in animal products. While there are veg-friendly foods that are fortified with B12, like some cereals, plant milks, and nutritional yeast, it's still easier to fall short if you're in this camp, Dr. Soffer notes. Because of the way B12 is absorbed via stomach acids, deficiency is also more common in those who have GI-related conditions. In particular, people who take common heartburn meds called proton pump inhibitors (that reduce stomach acid production) may be at higher risk, as are older adults, who just tend to have less stomach acid. (The number of people with B12 deficiency jumps from 6% to nearly 20% for the 60-plus population.) All types of B12, whether in animal sources or fortified foods, also need to sync up in the stomach with a protein called intrinsic factor in order to be fully absorbed. And some people might not make enough of this protein for that process to work. This can happen to those with a condition called pernicious anemia, as well as folks with certain GI disorders (like celiac or Crohn's) or alcohol use disorder (AUD), and those who've had bariatric surgery or another procedure that involved removing some or all of their stomach. So if you fall in one of these groups, there's reason to suspect you might be dealing with a bonafide B12 deficiency. (But if that's you, there's also a good chance you're already aware of your potential for nutrient deficiencies, Dr. Mock points out, and feeling fatigued will be far from your only symptom.) If you *do* have a B12 deficiency, a supplement isn't always the solution. In the particular cases above where a B12 deficiency could be on the table, your doctor may first run some routine bloodwork. This includes a measure of the average size of your red blood cells called mean corpuscular volume (MCV). A high MCV could prompt them to check your B12 level with an additional blood test, Dr. Mock says. (A normal MCV, by contrast, is reassurance that B12 probably isn't the issue, she adds.) If your B12 is indeed below the norm, it's important to work with your doctor to figure out how to raise your level. You might be able to do this via food, perhaps by eating more B12-fortified items. Experts agree, it's best to consume any vitamins and minerals via food because your body can use them more easily than in supplement form. Not to mention, the supplement industry is a hazy, unregulated one. These OTC products don't have to go through the same rigorous FDA approval process as medications, so it can be tough to know if you're getting what's on the label. That said, if your doctor does suggest taking an oral supplement to close the gap, they can steer you toward a reputable brand that's been third-party tested. They can also advise on the ideal dose and format (pill or under-the-tongue lozenge), and whether it makes sense for you to take a B-complex product (including a mix of B vitamins) or a standalone B12 supplement. Worth noting: In cases of deficiency caused by a GI or health condition that hinders absorption, just downing more B12 in supplement form might not solve the problem. After all, B12 in pills (or souped-up energy drinks) still needs to connect with intrinsic factor in the gut to get absorbed. That's why, in these specific situations, your doctor might recommend supplementing B12 via prescription injections or nasal gels, which bypass the GI route completely and go straight into your bloodstream. Bottom line: Most people with fatigue aren't lacking B12, so supplements aren't the solution. Low B12 is an uncommon reason for feeling tired. Chances are, if you have a deficiency, it coincides with one of the specific lifestyle or health-related situations above. 'Someone who has no known risk factors who truly has a vitamin B12 deficiency is a needle in a haystack,' Dr. Mock says. For most people, taking in extra B12 will just give you B12-rich pee…rather than any noticeable boost. So, what to do if you're feeling sapped and craving energy? Dr. Mock recommends turning to some tried-and-true lifestyle changes, like cutting down on screen time, getting outside in nature more often, fitting in daily movement (at least a few hours before bedtime), and eating a balanced diet that includes breakfast. These tips may not be as sexy as the latest B12-infused drip, drink, or pill, but they're bound to help you get better sleep at night and feel more rested and ready-to-go come daytime. If you try out a few of these and still can't seem to escape the drag of constant fatigue? It's worth seeing your doctor. Low B12 may not be the root cause—but they can certainly help you figure out if a medical condition might be lurking, and what you can do to get the pep back in your step. Related: 3 Things to Do When You're So, So Tired But Sleeping More Isn't an Option How to Feel Less Depleted by the End of the Workweek 6 Less Obvious Signs of Burnout You Should Definitely Pay Attention To Get more of SELF's great service journalism delivered right to your inbox. Originally Appeared on Self
