Latest news with #endocrinology
Yahoo
2 days ago
- Health
- Yahoo
FDA Approves SKYTROFA® (Lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Adults with Growth Hormone Deficiency
First of many planned label expansions supporting Vision 2030 goal to become the leading endocrinology rare disease company On track to initiate basket trial for ISS, SHOX deficiency, Turner syndrome, and SGA*, as well as combination therapy trials in achondroplasia and hypochondroplasia, in Q4 2025 COPENHAGEN, Denmark, July 28, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved SKYTROFA® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production. Lonapegsomatropin (approved by the FDA in 2021 for the treatment of pediatric GHD) is a prodrug of somatropin (human growth hormone, or hGH) administered once weekly, providing sustained release of active, unmodified somatropin. The FDA's approval of SKYTROFA for adult GHD was based on results from foresiGHt, a Phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) clinical trial that compared the efficacy and safety of weekly TransCon hGH with weekly placebo and daily somatropin in adults with GHD. 'The abnormal body composition, dyslipidemia, and insulin resistance that are the hallmarks of adult GHD predispose affected individuals to serious medical complications such as metabolic syndrome, increased cardiovascular risk, and impaired quality of life – including cognitive dysfunction, depression, anxiety, sleep disturbance, and reduced physical and mental drive. Despite this, adherence to daily somatropin injections that have been the standard of care for more than 25 years remains a problem,' said Kevin Yuen, M.D., Barrow Neurological Institute, University of Arizona College of Medicine and Creighton University School of Medicine in Phoenix, Arizona. 'It is no surprise that patients are looking for a less burdensome treatment regimen, and a new treatment option such as SKYTROFA, with once-weekly injection and its unique release of unmodified somatropin, is expected to help improve both real-world adherence and overall outcomes.' 'Our market research shows SKYTROFA is the treatment of choice for pediatric GHD among patients and physicians, and we are pleased to expand its availability in the United States for the treatment of adults initiating therapy or switching from another growth hormone therapy,' said Jan Mikkelsen, President and Chief Executive Officer at Ascendis Pharma. 'This important milestone is the first of many planned label expansions supporting our goal to become the leading endocrinology rare disease company.' The following information is intended for the U.S. Audience Only: IMPORTANT SAFETY INFORMATION & USES SKYTROFA is a prescription medicine used for: the replacement of growth hormone in children 1 year old or older who weigh at least 26 pounds (11.5 kilograms) with growth hormone deficiency (GHD) the replacement of growth hormone in adults with growth hormone deficiency (GHD) Do not take SKYTROFA if: you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems you are allergic to somatropin or any of the ingredients in SKYTROFA you are a child with closed bone growth plates you have cancer or other tumors you have certain types of eye problems caused by diabetes you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stopping breathing during sleep) Tell your healthcare provider if you are pregnant or plan to become pregnant, about all of your medical conditions, and about all the medicines you take. SKYTROFA may affect how other medicines work, and other medicines may affect how SKYTROFA works. What are the possible side effects of SKYTROFA? SKYTROFA may cause serious side effects, including: serious allergic reactions. Get medical help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing high risk of death in people who have critical illnesses caused by heart or stomach surgery, trauma, or serious breathing problems increased risk of growth of an existing tumor or cancer, or increased risk of a previous tumor or cancer returning in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems Your healthcare provider will need to monitor for the growth or return of a tumor or cancer. Contact your healthcare provider if you start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or skin color new or worsening high blood sugar or diabetes. Your blood sugar may need to be monitored during treatment with SKYTROFA increase in pressure in the skull. Contact your healthcare provider if headaches, eye problems, nausea, or vomiting occur too much fluid in the body (fluid retention). Contact your healthcare provider if you notice swelling in the hands and feet, pain in the joints or muscles, or nerve problems that cause pain, burning or tingling in the hands, arms, legs, and feet decrease in a hormone called cortisol. Your healthcare provider will do blood tests to check your cortisol levels decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well SKYTROFA works. Your healthcare provider will do blood tests to check your thyroid hormone levels hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help right away for children who develop a limp or have hip or knee pain worsening of curvature of the spine in children (scoliosis) severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your healthcare provider about any new abdominal pain loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your healthcare provider about rotating the areas where SKYTROFA is injected high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea increase in phosphate, alkaline phosphatase, and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this The most common side effects of SKYTROFA in children include: viral infection, fever, cough, nausea and vomiting, bleeding, diarrhea, stomach area pain, joint pain and arthritis The most common side effects of SKYTROFA in adults include: swelling due to fluid build-up and low thyroid hormone These are not all of the possible side effects of SKYTROFA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at You may also report side effects to Ascendis Pharma at 1-844-442-7236. Please click here for SKYTROFA full Prescribing Information. About Ascendis Pharma A/SAscendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis' future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis' plans to initiate basket trial for ISS, SHOX deficiency, Turner syndrome, and SGA, as well as combination therapy trials in achondroplasia and hypochondroplasia, in Q4 2025, (ii) SKYTROFA's ability to improve real-world adherence and overall outcomes, (iii) Ascendis' planned label expansions for SKYTROFA, (iv) Ascendis' goal of becoming the leading endocrinology rare disease company, (v) Ascendis' ability to apply its TransCon technology platform to make a meaningful difference for patients, and (vi) Ascendis' application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis' products and product candidates; unforeseen safety or efficacy results in Ascendis' development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis' development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis' business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis' ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis' business in general, see Ascendis' Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis' other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, and SKYTROFA® are trademarks owned by the Ascendis Pharma group. © July 2025 Ascendis Pharma A/S. Investor Contacts:Sarada WeerasingheAscendis Pharmair@ Media Contact:Melinda BakerAscendis Pharmamedia@ Patti BankICR Healthcare+1 (415) ----* ISS = idiopathic short statureSHOX deficiency = short stature homeobox-containing gene deficiencySGA = small for gestational ageSign in to access your portfolio
New York Times
07-07-2025
- Health
- New York Times
10 Menopause Myths the Experts Can't Stand
Inescapable hot flashes. Hormonal chaos. Sexless partnerships. Such stereotypes of menopause are deeply ingrained, and few are fully accurate. Menopause can produce symptoms in many parts of the body, and sometimes in unexpected ways, said Rebecca Thurston, an assistant dean for women's health research and a professor of psychiatry at the University of Pittsburgh. We asked gynecologists, endocrinologists, urologists and other experts about the biggest menopause misconceptions they had encountered. Here's what they want patients to know. Myth 1: It's just hot flashes. Hot flashes are a menopausal hallmark: Up to 80 percent of women have them. But numerous lesser-known symptoms are also linked to menopause, including insomnia, mood changes, brain fog, vaginal dryness, joint pain and more. That's largely because menopause is driven by changing levels of estrogen, which affects all tissues. During perimenopause, the years leading up to one's final menstrual period, estrogen fluctuates wildly. After menopause, it settles at a low level. Unfortunately, many people don't know the full range of symptoms this process can cause, said Dr. JoAnn Manson, an endocrinologist and professor at Harvard Medical School. That means they may not realize a symptom is menopause-related, which can mean missing out on helpful treatments. Want all of The Times? Subscribe.
Yahoo
01-07-2025
- Health
- Yahoo
6 Signs You Should See an Endocrinologist
Reviewed by Dietitian Maria Laura Haddad-GarciaSymptoms like low energy and weight loss from time to time can be normal, but these could be signs of a more serious issue. Consider seeing an endocrinologist if you have symptoms like dark patches of skin or excessive thirst. Diabetes, hypothyroidism and acanthosis nigricans are all conditions an endocrinologist can body's hormonal system is a delicate and complex network that impacts many aspects of your health. From energy levels to metabolism, mood to reproduction, hormones play a vital role in keeping everything running smoothly. When something goes awry in the hormone department, your body may show subtle (or not-so-subtle) signs that it's time to call in a specialist. That's where an endocrinologist comes in. Endocrinologists are medical experts in hormones and the glands that produce them, like the thyroid, pancreas and adrenal glands. If you're dealing with unexplained health concerns and aren't sure where to turn, understanding the signs that may indicate seeing an endocrinologist could make all the difference. We asked health experts to share red flags that might mean it's time to book an appointment. Keep reading to find out more about these six signs. Feeling tired now and then is normal, especially after a busy day or a poor night's sleep. But if you're constantly battling low energy and fatigue that doesn't improve no matter how much rest you get, it could be a sign of an underlying hormonal issue. One potential cause is hypothyroidism (an underactive thyroid), which slows your metabolism, leading to exhaustion, weight gain and sluggishness. Another potential cause? 'Chronic fatigue and abdominal pain could indicate Addison's disease, which is a lack of cortisol production by the adrenal glands, and is best worked up by an endocrinologist,' cautions Austin Shuxiao, M.D. An endocrinologist can assess whether your thyroid is functioning properly through specific blood tests that measure hormone levels, such as TSH (thyroid-stimulating hormone). Ignoring persistent fatigue can have long-term implications, so seeking professional guidance from a specialist is crucial if this symptom is disrupting your daily life. Have you noticed a drastic change in your weight, either a gain or loss, without altering your diet or exercise routine? 'Unexplained weight changes, whether sudden gain or loss, can be a sign that something more than diet and activity level is at play,' explains Lisa Young, P.h.D., RD. 'If you're eating consistently and staying active but your weight shifts dramatically, it may point to an underlying hormonal issue,' adds Young. 'Conditions like thyroid dysfunction, insulin resistance or adrenal imbalances can all affect how your body stores fat, burns energy and regulates appetite,' explains Young. 'An underactive thyroid (hypothyroidism) can slow metabolism, leading to weight gain, while an overactive thyroid (hyperthyroidism) may result in unintentional weight loss. These imbalances can make it difficult to maintain a healthy weight despite your best efforts, and may warrant a closer look by an endocrinologist.' With the stresses we experience in everyday life, feeling 'moody' can be normal on occasion. But if you are feeling 'mood swings' on a daily basis, hormones may be to blame. Conditions like thyroid disorders, menopause or adrenal gland dysfunction might be linked to frequent mood swings, anxiety or even depression. If these emotional changes seem to come out of nowhere, an endocrinologist may help you find the underlying cause. Menstrual irregularities, like infrequent periods, heavy bleeding or skipped cycles, could indicate hormonal concerns and may warrant a visit to an endocrinologist. These might be symptoms of an underlying issue like polycystic ovary syndrome (PCOS), a thyroid disorder or other hormonal concerns that can impact overall health and fertility. Some symptoms warrant a visit to a reproductive endocrinologist, an endocrinologist who specializes in diagnosing and treating hormonal and fertility-related conditions. You may consider visiting a reproductive endocrinologist if you face persistent menstrual irregularities, such as those previously mentioned, or if you have been trying to conceive without success for more than 12 months (or 6 months if you are over 35 years old). Additionally, conditions like recurrent miscarriages, a history of pelvic infections or structural abnormalities of the reproductive organs are strong indicators that a specialist's evaluation may be necessary. Diabetes is one of the most common endocrine-related concerns, caused by issues with insulin production or insensitivity. Symptoms like excessive thirst may signal diabetes or pre-diabetes. This occurs because high blood sugar levels lead to an increased concentration of glucose in the bloodstream. When the kidneys cannot reabsorb all this excess sugar, it is excreted in urine, along with significant amounts of water. This increased urination causes the body to lose fluids, triggering the sensation of thirst as the body attempts to replenish its water balance. If left unmanaged, these conditions may lead to serious complications affecting your heart, eyes, kidneys and nerves. Persistent dry mouth (xerostomia), especially when it's not linked to medications or hydration, is another related condition that may be a sign you need to see an endocrinologist, according to Sandip Sachar, DDS. 'Diabetes affects saliva production and increases the risk for gum disease, delayed healing and oral infections, adds Sachar. 'If I notice dry mouth in conjunction with other oral signs like frequent gum abscesses or slow healing after dental procedures, I might recommend the patient get evaluated by their primary care physician or an endocrinologist to rule out diabetes or other systemic conditions.' 'You should consider seeing an endocrinologist if you notice dark, thick, velvety patches of skin, especially in areas like the neck, armpit or groin,' explains Brittany Brown, RD, IBCLC, CDE. 'This skin change is called acanthosis nigricans, and can be an early sign of insulin resistance or hormonal imbalances.' Brown adds that this condition may point to a higher risk of developing diabetes or another endocrine condition, and early intervention can make a big difference for your health. Hormonal health is a pillar of overall wellness, but the signs that something is off can be easy to overlook or attribute to unrelated factors. Whether you're dealing with drastic changes in energy, mood, weight, or appearance, an endocrinologist has the expertise to uncover and treat the root cause. "If you feel like something's not right, push for answers. Hormonal problems are often dismissed or misdiagnosed, especially in women,' explains Ken Berry, M.D. If you recognize any of these signs in your life, don't hesitate to seek professional help. Catching and managing hormonal imbalances early may improve your quality of life and promote long-term health. Your body knows when something is wrong— listen to it, and get the care your body deserves. Read the original article on EATINGWELL
Medical News Today
01-07-2025
- Health
- Medical News Today
A fasting-mimicking diet may improve blood sugar control in type 2 diabetes
Dietary changes are a crucial component of managing type 2 diabetes and can even help achieve remission of the diets, which involve calorie restriction during specific hours or days, have been shown to be effective in alleviating symptoms of type 2 diabetes.A previous randomized controlled trial demonstrated that a monthly cycle of a fasting-mimicking diet that limits calorie intake during five consecutive days can lower blood sugar levels and reduce reliance on from a recent study provides real-world evidence to support the effectiveness of a 5-day fasting-mimicking diet, beyond the controlled conditions of a clinical trial. About 11% of the American population had diabetes in 2021, with type 2 diabetes accounting for 90% to 95% of these diets, which involve alternating periods of fasting and eating, are effective in alleviating the symptoms of type 2 diabetes and can be easier to follow than reducing daily calorie intake over a long time.A new study, conducted using real-world evidence, shows that individuals with type 2 diabetes who follow a fasting diet involving restricted energy intake for 5 consecutive days per month exhibit improvements in blood glucose (sugar) levels, weight loss, and a reduced reliance on diabetes fasting program has been patented by L-Nutra, a nutrient technology company. One of the study authors, William Hsu, MD, an endocrinologist and Chief Medical Officer at L-Nutra, told Medical News Today that:'This study demonstrates how the fasting-mimicking diet (FMD), when combined with physician oversight and registered dietitian (RD) coaching, can be safely and effectively implemented in real-world clinical settings to manage type 2 diabetes.'The researchers presented these results at the American Diabetes Association's 85th Scientific Sessions on June 20, 2025. The findings are yet to appear in a peer-reviewed do fasting diets work?The treatment for type 2 diabetes typically involves a combination of lifestyle modifications and medications. Lifestyle modifications, including dietary changes and increased physical activity, help lower blood glucose levels and facilitate weight medications such as metformin and GLP-1 agonists facilitate the management of diabetes symptoms, only lifestyle changes, such as dietary modifications, can lead to disease have shown that restricting daily calorie intake is effective in managing blood sugar levels and reducing weight in individuals with type 2 diabetes. However, adhering to such a diet over the long term is the body adapts to long-term calorie restriction, resulting in a slower metabolism, which makes sustained weight loss more various forms of fasting diets, involving alternating periods of fasting and unrestricted food intake, have been suggested to be easier to adhere to while alleviating diabetes triggers a stress response in cells and the body, promoting healthy aging by reducing inflammation and oxidative damage, while enhancing diets may involve either restricting calorie intake during certain hours of the day, known as intermittent fasting, or during specific days of the week or month, referred to as periodic fasting-mimicking diet is a form of periodic fasting that involves restricted calorie intake for 4 to 7 consecutive days per have developed the fasting mimicking diet to simulate the beneficial health effects of water-only fasting, which involves only water intake during a 24 to 72-hour period. In contrast to water-only fasting, a fasting-mimicking diet allows for limited calorie intake during the fasting period, making adherence less challenging. Blood sugar control: How is a 5-day fasting approach better?The authors of the current study have developed a patented low-calorie, plant-based diet that is low in sugar and protein, but rich in healthy unsaturated fats and fiber.A previous study demonstrated that a 5-day fasting-mimicking diet also leads to a decrease in blood sugar and insulin levels, while increasing the levels of ketone bodies. Moreover, a recent randomized controlled trial demonstrated that a 5-day fasting mimicking diet combined with medications was more effective than medications alone in improving blood glucose control and reducing medication reliance. These results were observed under highly controlled conditions in a clinical trial, including strict criteria for patient inclusion and exclusion. This makes it essential to evaluate the real-world efficacy of this impact of a fasting-mimicking dietIn the present study, researchers evaluated the real-world benefits of integrating a fasting-mimicking diet into routine care for individuals with type 2 present study included data from patients enrolled in a diabetes management program that involved following a monthly 5-day fasting-mimicking diet under the supervision of physicians and registered were enrolled in the study on a rolling basis, and data were collected from those who had completed at least 3 or 6 months of the the end of 3 and 6 months, the fasting-mimicking diet was effective in facilitating weight loss and reducing glycated hemoglobin levels, a marker of blood glucose levels. The fasting-mimicking diet also helped a greater percentage of participants achieve blood glucose control at these time points than at the time of fasting-mimicking diet also reduced reliance on medications for blood glucose control, while still resulting in high levels of engagement in the addition, Hsu noted: 'Most participants are able to integrate the fasting-mimicking diet into their daily lives without significant disruption. Because it's a 5-day monthly intervention rather than a daily regimen, many find it feasible to complete even with work and family obligations, especially with RD support to tailor practical strategies for adherence and personalization.'While the fasting-mimicking diet can be safely undertaken by most individuals with type 2 diabetes, patients should consult a physician before starting such a Routhenstein, MS, RD, CDCES, CDN, a preventive cardiology dietitian and heart health expert at Entirely Nourished, not involved in this study, expressed some caution about the findings.'While the positive effects of the FMD program on weight and HbA1c [a marker of blood sugar] are promising, it is important to note that the intervention was associated with common signs of energy deficit — including fatigue, headache, dizziness, and nausea — in a substantial number of participants during the 5-day fasting period,' Routhenstein told MNT.'Although these symptoms resolved between cycles, they may pose risks for certain individuals, especially those with coexisting health conditions or frailty,' she pointed also cautioned that: 'While the program accommodates most individuals with type 2 diabetes or metabolic syndrome, certain conditions are exclusionary, such as recent cardiovascular events, end-stage diabetes complications, frailty, a BMI under 18, or allergies to FMD ingredients. The program is designed to prioritize safety while expanding access to innovative nutrition-based care for metabolic health.'Finally, Routhenstein advised that 'the inclusion of lifestyle advice with the option to consult a dietitian may have influenced some of the study findings.'
Medscape
18-06-2025
- Health
- Medscape
Are Pre-Workout Powders Overloading the Heart?
Pre-workout supplements are gaining popularity in Brazil because of their promising effects, including increased focus, energy, endurance, enhanced performance, and reduced muscle fatigue. A growing number of brands are now available in specialty stores, pharmacies, and supermarkets. However, with so many options in the market, are consumers aware of the risks and product components, and do these products benefit physical performance? Typically sold in powdered soluble form, but also available as capsules, gummies, gels, or ready-to-drink liquids, pre-workout supplements combine various substances, such as caffeine, beta-alanine, arginine, taurine, and creatine, with formulas that vary by brand. 'Pre-workout [supplements] usually have a combination of multiple elements, such as vitamins, proteins and amino acids, but only a very small portion actually have any effect with proven scientific evidence on sports performance,' said Cristiano Barcellos, PhD, director of the Department of Sports and Exercise Endocrinology at the Brazilian Society of Endocrinology and Metabolism. Metabolic effects vary depending on the dosage of each component. Barcellos identified four substances with 'robust evidence' supporting their benefits in physical activity: Caffeine: increases alertness; the suggested daily dose (including coffee consumption) is 3-6 mg/kg of body weight Beta-alanine: increases cellular carnosine, blocking hyperacidity in muscles that compromises performance; ideal for intense exercises lasting 1-4 minutes Creatine: boosts strength and muscular endurance, particularly in short, high-intensity, intensive efforts Nitrate: improves circulation, supports long-duration aerobic activity Safety Concerns In addition to the aforementioned substances, a wide variety of others are also present in pre-workout supplements. These include citrulline, malate, arginine, taurine, tyrosine, branched-chain amino acids, and other adaptogens. Although they may produce the desired effects, current evidence supporting their impact on performance remains weak to moderate. Further studies are required to understand their mechanisms and effectiveness. Without understanding these components, individuals may take pre-workout supplements designed for short, high-intensity workouts but engage in prolonged aerobic activities, such as long-distance running or soccer. In such cases, in addition to a possible worsening of performance, there is a risk for unexpected adverse effects. 'There are reports of cases that require hospitalization and, occasionally, even result in death. The person ends up being exposed only to the side effects of these substances, so I personally do not recommend the use of these ready-made combinations,' said Barcellos. 'Qualified professionals, such as nutritionists or sports physicians, should advise using only the necessary components individually,' he concluded. Caffeine Risks Caffeine, one of the most common components in pre-workout supplements and proven to be effective as a stimulant and improve focus, is also among the most concerning. Some ready-made products exceed the recommended limit of 200 mg and contain up to 1 g of caffeine, posing a major health risk to consumers. Given the wide variability in dosages, inconsistent formulations, and often a lack of transparency in product labels, Luiz Eduardo Ritt, MD, PhD, president of the Department of Ergometry, Exercise, Nuclear Cardiology, and Cardiovascular Rehabilitation at the Brazilian Society of Cardiology, also advises against the use of ready-made blends. 'There is a large variation in the individual response to each pre-workout [supplement], with reports of patients who developed arrhythmias when making a more strenuous effort, both atrial and ventricular, the latter being more severe and with the potential to progress to cardiac arrest,' he said. Ritt emphasized a particular concern when caffeine is used in combination with hormones or antidepressants, which can increase the risk for arrhythmias. 'The mechanism involved is often related not only to increased adrenergic tone, which makes the heart more susceptible to arrhythmias, but also to the widening of the QT interval, a factor directly related to the occurrence of malignant arrhythmias, such as ventricular arrhythmias,' he explained. Beta-Alanine Beta-alanine, another common component of pre-workout supplements, raises concerns due to paresthesia, a side effect that causes tingling sensations in the extremities. Although this effect is common, it is not typically harmful. 'This effect is still being studied. We do not know exactly why this occurs, but we know that beta-alanine can bind to a neurologic receptor in the skin that is associated with the transmission of painful impulses to the brain, causing tingling. This is a temporary and self-limiting effect, with no apparent severity,' Barcellos explained. The National Health Surveillance Agency in Brazil (ANVISA) delayed the approval of beta-alanine due to several factors and only authorized its use in November 2020 after pressure from the sports sector. Until then, access was limited to imported products or compounded formulations, although this substance has been used internationally. A detailed review by the International Society of Sports Nutrition confirmed the ergogenic effects of beta-alanine, particularly in short, high-intensity workouts, and established a recommended dosage and favorable safety profile. Clinical Guidance Pre-workout supplement use should be personalized. 'It is necessary to analyze which product is being used, in what dose, individual sensitivity, and whether there is concomitant use with any other substance. The risks accumulate with each of these variables,' Ritt stated. A basic electrocardiogram can help detect cardiac rhythm abnormalities and elevated cardiovascular risk. 'We assess for signs of hypertrophy, ventricular dysfunction, impaired contractility, valvular abnormalities, or insufficiencies. Combined with a thorough medical history and physical examination, these findings help identify higher-risk individuals,' he said. All supplements and physical activities should be accompanied by a balanced diet. Natural foods have beneficial metabolic effects on humans. 'Nitrate is one of the most natural and effective compounds found in many vegetables, such as beetroot. It favors long-lasting activity by stimulating nitric oxide production in the arteries. There is no need to rely on powdered supplements if beetroot juice can provide the same effect,' said Barcellos, noting that nitrate is the only natural product with a proven effect on individual performance. Other natural products may have ergogenic properties without the need for commercial pre-workout supplements. These include coffee and guarana powder, which act as stimulants, and cinnamon and ginger, which are potentially beneficial for improving physical performance. 'Some vitamins and teas commonly used in nutrition also combine compounds with ergogenic potential. However, the effect varies from person to person, and excessive use can be risky, particularly because of possible liver toxicity,' Ritt noted. 'Natural does not mean harmless. Each factor must be carefully considered.' He also emphasized the importance of hydration in this regard. 'If physical exercise is intense, in conditions of high heat and humidity, and there is no adequate hydration, disorders may arise that lead to changes in sodium levels and hypernatremia. An excessive increase in body temperature can also lead to sudden illness, resulting from the combination of all these factors.'
