FDA to Review Drug for Exertional Heat Stroke

Eagle announced the complete submission to the Food and Drug Administration (FDA) of its New Drug Application (NDA) for Ryanodex for the treatment of exertional heat stroke (EHS).

Medical Licensing Exams May Be Lacking in the Field of Obesity

The most important concepts of obesity prevention and treatment are not adequately represented on the U.S. Medical Licensing Examination (USMLE) Step examinations, according to a study published recently in Teaching and Learning in Medicine.

FDA Grants Deuterated CF Therapy Orphan Drug Designation

The Food and Drug Administration (FDA) has granted Orphan Drug designation for Concert Pharmaceuticals' CTP-656 (deuterated ivacaftor) for the treatment of cystic fibrosis.

Get Up, Stand Up: Reducing Sitting Time Key to CRF Fitness

The reduction and interruption of sitting time can be an initial step in the development of a total physical activity plan for male patients, according to the conclusions of a report published in the December issue of the U.S. Centers for Disease Control and Prevention's Preventing Chronic Disease.

Oxytocin Treatment Assessed in Infants with Prader-Willi Syndrome

For infants with Prader-Willi syndrome (PWS), oxytocin (OXT) administration is associated with improvement in feeding and social skills, according to a study published online January 18 in Pediatrics.

MetS Patients May Require Significantly More Vitamin E

New research indicates that patients with metabolic syndrome (MetS) may need significantly more vitamin E than healthy patients, and that conventional blood tests may not provide an accurate measure of vitamin E levels.

Novel Urine Test Developed to Detect Dietary Patterns

Researchers from the the Imperial College London, Newcastle University, and Aberystwyth University have developed a urine test that can indicate how healthy a person's diet is, according to a study published in the Lancet Diabetes and Endocrinology.

Dietary Supplement May Carry Similar Safety Risks as Statins

Red yeast rice found in dietary supplements was linked to myopathies and liver injury and may not be a good choice for statin-intolerant patients, according to a study published in the British Journal of Clinical Pharmacology.

Update to Recommended Times for Infant Food Introduction

In a position paper published in the January issue of the Journal of Pediatric Gastroenterology and Nutrition, guidance is presented in relation to complementary foods and their introduction into an infant's diet.

New Year Detox May Have Triggered Life-Threatening Complication

The 47-year-old previously fit woman presented to the hospital following a short period of confusion and repetitive behavior.

FDA Warns Against the Use of Drug Promoted as 'Cancer Cure'

A laboratory analysis found the presence of Variovorax paradoxus.

Sugar Substitute Consumption On the Rise, Especially in Children

Researchers from George Washington University found that about 25% of children and >41% of adults in America reported an intake of foods and drinks containing low-calorie sweeteners (eg, aspartame, sucralose, saccharin) in a recent nutrition survey.

Chondroitin Sulfate vs. Celecoxib Data Announced for Knee OA

Bioberica announced positive results from the MOSAIC Study that evaluated the use of chondroitin sulfate for knee osteoarthritis.

Significant Weight Loss Seen with Contrave in Real-World Study

Orexigen Therapeutics announced that data from the IGNITE study have been published in the journal Obesity.

The Big Brain Diet: Older Adults Show Preserved Brain Health

The heart-healthy Mediterranean diet may also help preserve brain health in older adults, according to research published online in Neurology.

Omega-3 Consumption and Type 2 Diabetes: What's the Link?

Consumption of single omega-3 is associated with an increased risk of type 2 diabetes (T2D), with dosage, ethnicity, trial duration, and recruited age influencing the effect, according to a meta-analysis published online December 29 in the Journal of Diabetes Investigation.

Vitamin D Deficiency May Up Risk of Chronic Headache

Findings further support the evidence associating low vitamin D with increased risk of chronic diseases.

AACE/ACE Redefine 'Obesity' in New Position Statement

In 2012, the AACE described obesity as a disease state, which was officially adopted by the American Medical Association (AMA) in 2014.

Healthy Diet May Cut Premature Mortality Risk in CKD Patients

For patients with chronic kidney disease (CKD), a diet that stresses healthy food vs. individual ingredients may help reduce the risk of early death, a study published in the Clinical Journal of the American Society of Nephrology has found.

CDC Announces 7 U.S. Public Health Priorities

The Centers for Disease Control and Prevention (CDC) issued the final report on the Winnable Battles program which highlights public health priorities with large-scale impact on health and strategies that may help to address them.

Guidelines for NAFLD Management in Children Published

The American Academy of Pediatrics has endorsed new guidelines recommending the screening of all obese children aged 9 to 11 for non-alcoholic fatty liver disease (NAFLD).

Rare Liver Disorder Therapy Designated Orphan Drug

PhaseRx announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for PRX-OTC for the treatment of ornithine transcarbamylase deficiency (OTCD).

Drug Combo May Benefit Weight-Concerned Smokers Who Want to Quit

In a first-ever prospective study evaluating lorcaserin in reducing post-cessation weight gain in overweight and obese smokers, researchers found that lorcaserin combined with varenicline minimized weight gain and increases in waist circumference.

Weight Gain Concerns May Impact Birth Control Choice

Concerns about gaining weight may impact contraception choices for women.

Unhealthy Weight Management Linked to Adolescent Rx Drug Use

Seventeen percent of high school students say they have engaged in non-medical use of prescription drugs (NMUPD), according to a recent Youth Risk Behavior Survey.

Novel Mucopolysaccharidosis Tx Designated Orphan Drug

Eloxx announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to ELX-02, its propriety drug candidate for the treatment of mucopolysaccharidosis type 1 (MPS I).

Maternal Vit B12 Deficiency May Up Diabetes Risk in Offspring

New research has found that antenatal B12 deficiency may be tied to higher than normal leptin levels in offspring, which can lead to type 2 diabetes.

Is Vit D Deficiency Tied to Higher Risk of Bladder Cancer?

Patients who were vitamin D deficient had an increased risk of developing bladder cancer, a systematic review presented at the Society for Endocrinology annual conference has concluded.

Can Restoring Vit D Levels Improve Adherence in Statin Rechallenge?

For patients with statin-induced myopathy, restoring low vitamin D levels appeared to be help improve medication adherence and ultimately prevent cardiovascular and mortality events, according to a study published in the Journal of Pharmacy Practice.

Belviq XR Now Available for Chronic Weight Management

Belviq XR, a CIV controlled substance, was initially approved by the Food and Drug Administration (FDA) in July 2016.

FDA Approval Expands Orkambi Use in Pediatric Patients with Cystic Fibrosis

Vertex announced that the Food and Drug Administration (FDA) has approved Orkambi (lumacaftor and ivacaftor) tablets for use in children with cystic fibrosis aged 6-11 years who have 2 copies of the F508del mutation.

Tylactin RESTORE Powder Available for Tyrosinemia Management

Cambrooke Therapeutics announced the launch of Tylactin RESTORE Powder, a new medical hydration beverage for the dietary management of tyrosinemia.

Glytactin RESTORE Powder Packets Approved for PKU Patients

Cambrooke Therapeutics announced the launch of Glytactin RESTORE Powder and Glytactin RESTORE Lite Powder, new medical food hydration beverages for the dietary management of phenylketonuria (PKU).

FDA Approves Lomaira as Adjunct Tx in Weight Loss

The Food and Drug Administration (FDA) has approved Lomaira (phentermine HCl; KVK Tech) tablets as a short-term adjunct in a regimen for weight reduction.

Insulin Sensitivity and Anabolic Steroids: What's the Link?

Use of anabolic androgenic steroids (AAS) may lead to insulin resistance, according to a study presented at the annual meeting of the European Association for the Study of Diabetes, held from September 12 to 16 in Munich.

Can Cinnamon Supplements Help with Glycemic Control in T2DM?

A literature search identified 11 randomized controlled trials.

Swallowable Intragastric Balloon System Gains Approval for Weight Loss

The System is intended for use as adjunct to a behavior modification program and a moderate intensity diet.

Can Vitamin D Help Reduce the Risk of Asthma Exacerbations?

For patients with asthma, vitamin D appears to reduce the risk of severe asthma exacerbations and health care use, according to a review published online in the Cochrane Library.

Drop in Congenital Heart Defects Tied to Folic Acid-Fortified Foods

The introduction of folic acid-fortified foods in Canada was associated with a decrease in infants being born with congenital heart defects (CHDs), according to a study published in Circulation.

FDA: Natural Herb Coffee Found to Contain Undeclared Drug

The Food and Drug Administration (FDA) is warning consumers not to buy or use Kopi Jantan Traditional Natural Herbs Coffee.

High-Intensity Ultrasound Demonstrates Efficacy in Fat Reduction Study

A novel high-intensity focused ultrasound (HIFU) treatment with a cooling system is safe and efficient for destroying adipocytes, according to a study published online August 23 in Lasers in Surgery and Medicine.

Some Good News for Cheese Lovers

Researchers aimed to compare the effects of regular-fat cheese with an equal amount of reduced-fat cheese and an isocaloric amount of carbohydrate-rich foods on LDL cholesterol levels and the risk factors for metabolic syndrome.

Dietary Supplement May Promote Hair Growth in Men

A marine complex supplement is beneficial for men with thinning hair, according to a study published online August 9 in the Journal of Cosmetic Dermatology.

CDC: Only Half of Mothers Breastfeed for Recommended Duration

Even though most new mothers in the United States begin breastfeeding their infants at birth, many stop sooner than recommended, according to the 2016 Breastfeeding Report Card from the U.S. Centers for Disease Control and Prevention.

Gripe Water with Probiotic Now Available for Infants

Wellements announced the launch of Wellements Probiotic Gripe Water, the first gripe water to contain probiotics, to help ease a newborn's stomach discomfort often associated with gas, colic, fussiness, and hiccups.

A Shift From Weight to Health Talk May Help Curb Obesity, Eating Disorders in Teens

When teenagers are overweight, parents and doctors should encourage a healthy lifestyle rather than focus on the number on the scale, according to new guidelines issued by the American Academy of Pediatrics (AAP) and published online in Pediatrics.

Does Higher BMI Affect Hormonal Contraceptive Efficacy?

A review published in the Cochrane Database of Systematic Reviews generally found no association between higher body mass index (BMI) or weight and hormonal contraceptive efficacy.

First Four-Oil Parenteral Nutrition Product Available

Fresenius Kabi announced the launch of Smoflipid, a parenteral nutrition product, for use in adults.

Are PPI Users at Risk for Vitamin B12 Deficiency?

Proton pump inhibitors (PPIs) were associated with a higher risk of inducing vitamin B12 deficiency than histamine-2 receptor antagonists (H2RAs) but longer prospective studies are needed to confirm this finding, study authors concluded in the Journal of Pharmacy Practice.

Time Spent Overweight May Affect a Woman's Cancer Risk

The longer a woman is overweight, the higher her risk of several cancers, according to a study published online August 16 in PLOS Medicine.

Orlistat-ART Interaction Warning Added to Labeling

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xenical (orlistat; Genentech) capsules regarding the risk of loss of virological control in patients with HIV infection taking concomitant antiretroviral agents.

DASH Diet May Benefit Gout Patients

A study published in Arthritis & Rheumatology has found that the DASH diet reduced serum uric acid, particularly in patients with hyperuricemia.

Major Recall of Liquid Drugs, Supplements Due to Potential Bacterial Contamination

PharmaTech announced a voluntary recall of all liquid products due to a potential risk of contamination with Burkholderia cepacia.

Risks Associated with Night Hypoxia in Obese Peds

Obstructive sleep apnea (OSA)/hypoxia is associated with progression of nonalcoholic steatohepatitis (NASH) in pediatric patients with nonalcoholic fatty liver disease (NAFLD), according to a study published online August 5 in the Journal of Hepatology.

Risk of Vitamin D Drop After Stopping Certain Contraceptives, Study Finds

Researchers from the National Institute of Environmental Health Sciences in Research reported that women risk having their vitamin D levels drop when they cease using contraceptives containing estrogen.

Soy Isoflavones May Benefit Patients with PCOS

Consuming soy isoflavones may improve cardiovascular and metabolic health in women with polycystic ovary syndrome (PCOS), results from a new study in the Journal of Clinical Endocrinology & Metabolism has found.

Trends in Vitamin D Status of the U.S. Population: 1988-2010

Mean vitamin D concentrations among Americans remained stable between 1988-2006 and showed modest increases between 2007-2010.

Eating More Nuts May Improve Inflammatory Biomarkers, Study Suggests

Habitual nut consumption was associated with a healthy profile of inflammatory biomarkers, researchers from Brigham and Women's Hospital and Harvard Medical School reported.

Does St. John's Wort Reduce Hormonal Contraceptive Efficacy?

Although evidence is limited, a new systematic review in Contraception indicates a greater risk of ovulation and breakthrough as well as reduced contraceptive efficacy when combined oral contraceptives (COCs) are co-administered with St. John's wort.

Vitamin C and Back Pain: What's the Link?

To analyze vitamin C level outcomes, researchers used the U.S. National Health and Nutrition Examination Survey database.

Experimental Drug Shows Promise in Proopiomelanocortin Deficiency

An experimental drug spurred substantial weight loss in patients with proopiomelanocortin (POMC) deficiency, according to a study published in the July 21 issue of the New England Journal of Medicine.

Experts Believe Pokémon Go Could Encourage a Healthier Lifestyle

The popularity of the mobile video game Pokémon Go may be contributing to a healthier lifestyle for many players, according to some experts.

New Research Suggests Even a High-Fat Mediterranean Diet Is Beneficial

Even a high-fat Mediterranean diet may protect against breast cancer, diabetes, and cardiovascular disease, according to a review published online in the Annals of Internal Medicine.

Does Reducing Caffeine Intake Help Prevent PMS?

Decreasing caffeine intake may not help women prevent premenstrual syndrome (PMS), a team of researchers reported.

FructosAid88 Available for Fructose Malabsorption

FructosAid88 (xylose isomerase), the first enzyme supplement for fructose malabsorption, is now available.

Belviq XR Approved for Chronic Weight Management

Eisai and Arena announced that the Food and Drug Administration (FDA) has approved Belviq XR (lorcaserin HCl extended-release tablets).

FDA Approves Increase in Amount of Vitamin D Allowed in Milk, Milk Alternatives

The Food and Drug Administration (FDA) approved an increase in the amount of vitamin D allowed in milk, milk alternative beverages and plant-based yogurt alternatives.

Study Shows Diet-Induced Weight Loss Can Lower the Risk of CA in Obese Women

Overweight and obese women who lose weight via calorie restriction, with or without exercise, may lower their odds of developing cancer as their levels of proteins tied to angiogenesis drop, according to a study published online in Cancer Research.

Is Early Childhood Obesity Tied to Antibiotic Exposure?

Antibiotic exposure is associated with increased odds of obesity among young children, according to a study published in Gastroenterology.

Water Intake May Play a Role in Weight Management, Study Finds

Staying adequately hydrated may be associated with a lower risk of obesity, according to a study published in the July/August issue of the Annals of Family Medicine.

DPP-4 Inhibitors Linked to Improved Vitamin D Balance in T2DM Patients

Findings from a study published in Acta Diabetologica support that treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors is associated with better vitamin D balance in patients with type 2 diabetes.

Dronabinol Oral Solution Approved by FDA

The FDA has approved Syndros (dronabinol oral solution) for the treatment of anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Weight Loss May Lessen Severity of Psoriasis, Study Finds

For patients with psoriasis, long-term weight loss had lasting beneficial effects on the severity of psoriasis, according to a study published in the American Society of Nutrition.

Energy Drinks May Significantly Increase Blood Pressure

Consuming caffeinated energy drinks can significantly increase systolic and diastolic blood pressure (BP).

Benefits of Vitamin D: How Much Evidence is Really Out There?

Examining vitamin D from a scientific standpoint finds that many supposed benefits are not validated.

PreserVision AREDS Formula + Multivitamin Launched for AMD Patients

Valeant announced that PreserVision AREDS 2 Formula + Multivitamin is now available for patients with moderate to advanced age-related macular degeneration.

Glassia Now Approved for Self-Infusion at Home

Shire and Kamada announced that the Food and Drug Administration (FDA) has approved Glassia (alpha-1 proteinase inhibitor [human]) as the first treatment for adults with emphysema due to severe alpha-1 antitrypsin (AAT) deficiency that can be self-infused at home after appropriate training.

Higher Dosage Strength for HT-1 Treatment Approved

Sobi announced that the FDA has approved a new 20mg strength of Orfadin (nitisinone) capsules for the treatment of hereditary tyrosinemia type-1 (HT-1), a rare genetic disease in infants and children.

Unique Obesity Treatment Device Gets FDA Approval

The device - which is inserted through a small incision in the abdomen - was associated with a ~12.1% total body weight loss in a clinical trial.

Canagliflozin/Phentermine Combo Evaluated in Weight Loss Study

Janssen announced findings of a Phase 2 proof-of-concept clinical trial demonstrating that combination therapy of canagliflozin and phentermine was effective for weight loss in overweight or obese non-diabetic adult patients. Data were presented as a late-breaking poster presentation at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA).

FDA Takes on Thousands of Websites Selling Illegal Prescription Drugs

The Food and Drug Administration (FDA) announced that it has taken enforcement action on 4,402 websites illegally selling potentially dangerous, unapproved prescription drugs to U.S. consumers.

Multivitamins Recalled Due to Potential Salmonella, S. aureus Presence

Pharmavite announced the recall of certain lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination.

Adding Vitamin D May Reduce Side Effect of Certain Antipsychotic Drugs

Adding vitamin D may lessen the risk of developing new-onset diabetes in patients taking atypical antipsychotics, according to a study published in Scientific Reports.

FDA Guidance Sets Sodium Reduction Targets for Processed Foods

The FDA issued both short- and long-term targets to gradually reduce sodium levels in processed and prepared foods.

Priority Review Granted For New Orkambi Indication

Vertex has announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to their supplemental New Drug Application (sNDA) for Orkambi (lumacaftor/ivacaftor).

Nutrition Facts Label Gets a Much Needed Update

The Food and Drug Administration today announced new updates to the nutritional facts label to appear on most packaged foods sold across the U.S.

The Gluten-Free Diet: Separating Fact from Fiction

A new commentary published in the Journal of Pediatrics calls for healthcare providers to play a greater role in educating non-celiac disease patients on the consequences of converting to a gluten-free diet (GFD).

Can Omega-3 Help Lower Childhood Aggression?

Previous studies have suggested that nutritional supplementation may lower aggressive behavior in children.

Recall: Sildenafil Discovered in Dietary Supplements

SOS Telecom is voluntarily recalling four of their products that were marketed as dietary supplements for male sexual enhancement. The product names are, Tiger-X, Ninja-X, Ginseng Power-X, and Super Samurai-X.

Does Too Much Folate During Pregnancy Up Autism Risk?

Researchers from Johns Hopkins Bloomberg School of Public Health reported that too much folate in a new mother's body may increase a child's risk of developing an autism spectrum disorder. Findings from the study will be presented at the 2016 International Meeting for Autism Research.

Orphan Drug Status Granted to Hyperoxaluria Treatment

The FDA has granted Orphan Drug designation to ALLN-177 (oxalate decarboxylase; Allena) for the treatment of pediatric hyperoxaluria.

How Does Coffee, Tea Consumption Impact Estimated GFR?

Consuming multiple cups of coffee a day is likely to be safe for the kidneys in the general population, and is associated with an increase in estimated glomerular filtration rate (eGFR), according to findings of a study from the Netherlands.

Herbal Remedies May be "Global Health Hazard," Commentary Suggests

In a commentary published in EMBO reports, study authors present data showing that herbals containing Aristolochia species can cause aristolochic acid nephropathy (AAN).

Diluted Apple Juice Suitable Alternative for Kids with Mild Gastroenteritis

For children with mild gastroenteritis and minimal dehydration, initiating diluted apple juice followed by their preferred fluids led to fewer treatment failures vs. electrolyte maintenance solution, according to findings from a study published in JAMA.

FDA Approves Oral Suspension Formulation for HT-1 Treatment

The Food and Drug Administration (FDA) has approved Orfadin (nitisinone; Sobi) Oral Suspension for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

Adding These Nutraceuticals May Improve Antidepressant Therapy

Findings from a new study published in The American Journal of Psychiatry suggest that some nutritional supplements can enhance the efficacy of antidepressants for patients with depression.

Orphan Drug Status Granted to Inhaled Antimicrobial Agent Mul-1867

The FDA has granted Orphan Drug designation to Mul-1867 (TGV-Inhalonix) for the treatment of antibiotic-resistant bacterial lung infections in patients with cystic fibrosis.

Three Undeclared Drugs Found in Weight Loss Capsules

Super Herbs announced a voluntary recall of its Super Herbs light green and dark green capsules after FDA laboratory testing found them to contain sibutramine, desmethylsibutramine, and/or phenolphthalein.

Dietary Supplements for Dysmenorrhea: Are Any Effective?

A Cochrane review found no high quality evidence to support the efficacy of any dietary supplement for dysmenorrhea.