health and wellness
FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance
Today, the U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.
“It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”
LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye. LASIK surgery is intended to correct common vision problems such as nearsightedness, farsightedness, and astigmatism and to reduce a person’s dependency on eyeglasses and contact lenses.
The draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” details the FDA’s proposed recommendations for the content and format of patient labeling for LASIK devices, including general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information. In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling information that physicians provide to their patients prior to the procedure. To ensure the patient decision checklist is clearly understood by patients, the proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure. It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed.
The FDA collaborated with external experts on research efforts that informed the recommendations in the draft guidance. The agency, in collaboration with the National Eye Institute and the Department of Defense, conducted research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS)External Link Disclaimer, questionnaire, qualified through the FDA’s Medical Device Development Tools (MDDT) program.
By issuing draft guidance for public comment, the FDA is encouraging feedback on the proposed labeling recommendations from patients, health care providers and stakeholders. The FDA will continue to monitor the latest scientific data related to LASIK and work with professional medical societies and patient advocacy groups to help ensure that risk information about LASIK devices is disseminated to patients, as new information becomes available.
Related Information
- Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations
- LASIK
- Medical Device Development Tools (MDDT) Program
Source: FDA
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Family
5 consejos para la salud del corazón para las fiestas
La comida, las bebidas, los regalos y el tiempo con la familia hacen de las fiestas una ocasión feliz para las personas de todo el país. Sin embargo, toda esa celebración a veces puede convertirse en una distracción para mantener la salud del corazón.
(Family Features) La comida, las bebidas, los regalos y el tiempo con la familia hacen de las fiestas una ocasión feliz para las personas de todo el país. Sin embargo, toda esa celebración a veces puede convertirse en una distracción para mantener la salud del corazón.
De hecho, las alegrías de la temporada pueden estropearse para muchos, ya que las investigaciones muestran un aumento en los eventos cardíacos y las muertes por ataques cardíacos durante la última semana de diciembre. Según un estudio publicado en la revista de la American Heart Association, “Circulation”, ocurren más muertes por problemas cardíacos el 25 de diciembre que cualquier otro día del año, seguidas por el segundo número más grande el 26 de diciembre y el tercero el 1 de enero.
“Las vacaciones son un momento ajetreado, a menudo estresante, para muchos de nosotros”, dijo Mitchell S.V. Elkind, MD, MS, FAHA, director de ciencias clínicas de la American Heart Association. “Las rutinas se interrumpen. Es posible que tendamos a comer y beber más y a hacer menos ejercicio y relajarnos menos. Dormimos muy poco y experimentamos demasiado estrés. Si bien no sabemos exactamente por qué hay más ataques cardíacos mortales durante este tiempo, es importante tener en cuenta que estos factores pueden incrementarse, aumentando el riesgo de un evento cardíaco mortal”.
Ser consciente de este fenómeno anual y tomar algunas medidas importantes y saludables para el corazón puede ayudar a salvar vidas. Considere estos consejos del Dr. Elkind y los expertos de la American Heart Association.
- Conozca los síntomas y tome medidas. Los signos de un ataque cardíaco varían en hombres y mujeres, pero es importante reconocerlos temprano y llamar al 9-1-1 para obtener ayuda. Cuanto antes comience el tratamiento médico, mayores serán las posibilidades de supervivencia y de prevención del daño cardíaco.
- Celebre con moderación. Comer saludablemente durante las fiestas no tiene por qué significar privarse. Hay maneras de comer de manera inteligente, como limitar la ingesta de sodio y buscar pequeños intercambios saludables para que continúe sintiéndose lo mejor posible mientras come y bebe con moderación.
- Practique la buena voluntad hacia sí mismo. Tómese un tiempo para cuidarse durante esta temporada ajetreada. Leer un libro favorito, meditar o incluso jugar con mascotas son formas productivas de reducir el estrés de las interacciones familiares, las finanzas tensas, los horarios agitados, los viajes y otros factores estresantes que pueden provocar las vacaciones.
- Siga moviéndose. El ajetreo y el bullicio de la preparación para las fiestas a menudo deja de lado el ejercicio, pero es importante mantenerse activo tanto como sea posible. Sea creativo para mantenerse en movimiento dando un paseo familiar o jugando juegos físicamente activos con sus seres queridos.
- Tome sus medicamentos. Los horarios ocupados pueden hacer que algunas personas se salten los medicamentos, a veces incluso los olvidan en casa o no renuevan las recetas a tiempo. Trate de usar un cuadro de medicamentos como recordatorio y asegúrese de controlar los números de su presión arterial.
Descubra más formas de vivir una vida saludable para el corazón durante las fiestas y durante todo el año en heart.org.
Foto cortesía de Getty Images
SOURCE:
American Heart Association
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fitness
Scaling Back: 5 ways to manage your weight
For many people who wish to work toward a healthier weight, one of the greatest obstacles is figuring out where to begin.
(Family Features) For many people who wish to work toward a healthier weight, one of the greatest obstacles is figuring out where to begin.
These tips from SlimFast consultant and registered dietitian Maryann Walsh show it doesn’t take a drastic lifestyle overhaul to make an impact.
Eat Mindfully
Many people who struggle with their weight benefit from being more conscious about what they’re eating and why. For example, consider your eating habits, such as eating even when you’re not hungry whether that’s because it’s mealtime and you think you should eat, you’re satisfying a craving or using a tasty snack to cope with stress.
Recognizing why you’re eating is an important step toward correcting destructive eating patterns, but so is paying attention to the other details of the eating experience, including what you eat and how it makes you feel. Ultimately, this may allow you to choose healthier foods that nourish your body for the long-term, rather than the brief satisfaction that comes with less nutritious choices.
Consider Intermittent Fasting
One weight-loss method many people find success using is intermittent fasting, which involves abstaining from all food and beverages for a specified time period each day or week. While going too long without food can sometimes lead to excess hunger then overeating later, in shorter, controlled fasting timeframes one can often more easily achieve a caloric deficit, which is required for weight loss.
Prepare for your fasting phase by choosing foods that support satiety. Options like SlimFast’s Intermittent Fasting line of meal bars and protein shakes can help avoid a sense of deprivation with tasty flavors like the Vanilla Cupcake Snack Shake Mix and Vanilla Almond Crunch Complete Meal Bar. The shake mixes deliver 15 grams of slow-digesting protein, compared to whey protein, to help curb hunger, along with more than 20 vitamins and minerals. The meal bars clock in with 15 grams of protein and 10 grams of fiber.
Manage Stress
When you’re stressed, your body produces cortisol, which also raises insulin and can drive hunger and trigger cravings for comfort foods. In fact, that’s the very reason people tend to overeat when they’re under pressure. Light exercise and meditative practices can help you manage your mental strain. You might also consider talk therapy with a friend or professional or spend time unwinding with a book or music.
Get Proper Sleep
Poor sleep habits affect your weight in numerous ways. One is that when you’re feeling tired, your hunger and satiety hormones, ghrelin and leptin, can be affected, leading to an increase in caloric intake and subsequent weight gain. Additionally, when you’re tired, you’re more likely to take shortcuts like skipping workouts or opting for unhealthy convenience foods. All are reasons to make better rest a bigger priority.
Track Eating and Exercise
When you’re not paying attention to what you eat and how you move, you may not even realize how your habits are affecting your health. Logging what you eat, especially if you use a tool like an app that helps you see the nutrition breakdown, may give you a clearer idea of the quality and quantity of your intake. Similarly, when you’re specifically writing down the time you’re committing to physical activity, you’ll find it easier to identify patterns and pinpoint where you can make adjustments to increase your exercise.
Visit SlimFast.com to find more resources on weight management and intermittent fasting.
3 Tips for Intermittent Fasting
If you’re new to the idea of intermittent fasting, these tips can help you find greater success so you can see results.
- Pace yourself. Make a gradual transition so your body gets used to going without food for shorter periods of time before you work up to extended fasting periods.
- Stay hydrated. Avoid confusing thirst for hunger by upping your fluid intake. Staying hydrated and energized while you fast helps keep fatigue and brain fog at bay. Options like fruit-flavored SlimFast Intermittent Fasting Energizing Hydration Supplement Drink Mix won’t break your fast and can help you add variety as a flavorful alternative to water. They can provide the energy and focus you need between meals and are perfect for those who feel groggy or run-down while fasting.
- Set goals. Know what you want to achieve and why, so your “why” can keep motivating you to follow your intermittent fasting plan even when you’re tempted to quit.
Photo courtesy of Getty Images (woman and man exercising)
SOURCE:
SlimFast
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scooping chocolate ice cream
Wells Enterprises, Inc., America’s largest privately held, family-owned ice cream manufacturer, has initiated a nationwide voluntary recall affecting more than 50,000 gallons of ice cream and frozen yogurt products due to potential plastic contamination.
Key Recall Details
Affected Products: Nearly 18,000 three-gallon containers across 22 varieties
Popular Brands Involved: Blue Bunny, Halo Top, and other Wells Enterprises products
Distribution: Products shipped to 103 distribution centers nationwide
Best-By Dates: March through October 2026
Recall Classification: FDA Class II recall
Consumer Safety Alert
The company took immediate action after discovering the possibility of foreign material (plastic) in select products. While no injuries have been reported, consumers are urged to:
Check product codes against the recall list
Stop using affected products immediately
Return items to the place of purchase for a full refund
Contact Wells Enterprises customer service with questions
Affected Product Information
The recall specifically impacts 3-gallon bulk containers of various ice cream and frozen yogurt flavors. Wells Enterprises, known for producing popular brands including Blue Bunny, Halo Top Creamery, and The Cheesecake Factory At Home ice cream products, initiated the voluntary recall on April 25, 2025.
For More Information
Consumers can visit the FDA’s official website or follow STM Daily News’ Food and Drink section for the latest updates on this recall and other food safety alerts.
Related Links:
https://abcnews.go.com/Business/wireStory/ice-cream-maker-issues-recall-concerns-plastic-121931178
At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.
Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.
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