Experts Weigh In on the Best Diets for 2018

DASH and the Mediterranean diet also tied for top stop in the 'Best Diets for Healthy Eating' category will DASH ranked number 1 for the 'Best Heart-Healthy Diets'.

Impact of Maternal Folate Status on Child's Autistic Traits After AED Exposure

Children exposed to antiepileptic drugs (AEDs) in utero may have a reduced risk of autistic traits with periconceptional folic acid supplementation and folate status

Do Vitamin D, Calcium Supplements Cut Fracture Risk in Older Patients?

Thirty-three randomized trials (n=51,145) were identified that met the inclusion criteria.

Can Probiotics Prevent C. difficile-Associated Diarrhea?

Analysis of all patients who completed the study (N=8,672) found that probiotics reduce the risk of CDAD by 60%. Among the probiotic group the incident of CDAD was 1.5% (70/4,525) compared to 4% (164/4,147) in the placebo.

FDA: New Risk-Based Approach to Regulate Homeopathic Products

FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients.

New App Helps Caregivers Monitor Nutrition, Growth of Tube Fed Children

The app is designed to make it easier for caregivers of children who are tube fed to monitor their child's nutrition, tolerance, and overall growth and development.

Drug-Free Supplements Launched for Menopause Symptom Relief

The drug-free supplements also contain varying levels of flax, vitamin B2, vitamin B6, D-biotin, and vitamin D3.

Early Treatment With Kalydeco Investigated in Young Cystic Fibrosis Patients

Sweat chloride, a diagnostic characteristic of CF, was also considerably reduced with ivacaftor treatment. Median baseline sweat chloride levels were 104.1mmol/L.

FDA: Vitamin May Interfere With Lab Tests, Already One Fatality Reported

The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests.

FDA: Potentially Life-Threatening Adverse Events Linked to Limbrel

The FDA is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.

Mepsevii Approved to Treat Rare Genetic Disease

Mepsevii (vestronidase alfa-vjbk) was evaluated by the FDA with Priority Review.

Anti-Inflammatory Foods May Help With RA Symptoms, Progression

Specific foods that were highlighted include dried plums, blueberries, pomegranates, whole grains, ginger, turmeric, specific oils, and teas; these foods were found to reduce inflammatory cytokines, joint stiffness, pain, and oxidative stress.

Nutritional Interventions Could Benefit Chronic Kidney Disease

Dietary interventions may be used for conservative uremia management and to delay or prevent dialysis therapy, say the authors of the review.

Ascor Approved for the Treatment of Scurvy

While the exact mechanism of action of ascorbic acid in the treatment of scurvy is unknown, administration is believed to restore the body pool of ascorbic acid.

Pompe Disease Treatment Granted Orphan Drug Designation

ATB200 is a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures while AT2221 is a pharmacological chaperone.

Increased Med Use Over Time Seen in Older Patients of All BMI Classes

Researchers aimed to determine whether the rise in prescription drug use over time varied by age and obesity status.

Vit D Deficiency: A Risk Factor for MS?

Data showed that a 50nmol/L increase in 25(OH)D correlated with a 39% decreased risk of MS. Specifically, a 43% increased risk of MS was seen in women with 25(OH)D levels <30nmol/L vs. women with levels ≥50nmol/L.

Long-Term Outcomes of Roux-en-Y Gastric Bypass

The researchers found that the adjusted mean changes from baseline in body weight in the surgery group were −45.0, −36.3, and −35.0 kg at 2, 6, and 12 years, respectively.

Daily Consumption of 'Cancer Preventative' Leads to Cyanide Poisoning

The patient admitted to taking 2 teaspoons of self-prepared apricot kernel extract along with 3 tablets of Novodalin, an herbal fruit kernel supplement, every day for the past 5 years.

Administration Issues Prompt Recall of Infant Supplement

If the product is not administered exactly as the labeled instructions, it may pose swallowing difficulties and may be a possible choking hazard due to the thickness of the liquid.

Drug-Dietary Supplement Interaction Leads to Surgical Emergency

This case demonstrates how important it is for clinicians to be able to identify dietary supplements that can lead to dangerous drug-drug interactions.

Reduced Dosing Option Approved for Orfadin in HT-1

The approval of the once-daily dosing option was based on a clinical study that compared a 4-week once-daily regimen to a 4-week twice daily regimen.

Tezacaftor/Ivacaftor Gets Priority Review for Cystic Fibrosis

The FDA has granted Priority Review to the New Drug Application (NDA) of tezacaftor/ivacaftor (Vertex) for the treatment of patients ≥12yrs old with cystic fibrosis (CF) who have two copies of the F508del mutation or one F508del mutation and one residual function mutation.

Long Term Vitamin Use Tied to Significant Increase in Cancer Risk

Upon evaluation of the 10-year average supplement dose, it was found that lung cancer risk increased almost 2-fold in men taking >20mg/day of vitamin B6 (HR: 1.82; 95% CI: 1.25, 2.65) and >55mg/day of vitamin B12 (HR: 1.98; 95% CI: 1.32, 2.97) versus nonusers.

Licorice Supplements May Put Patients at Risk for Drug Interactions

More women are looking toward alternatives like licorice due to, "concerns about the risk of stroke and breast cancer associated with conventional hormone," said Richard B. van Breemen, PhD, and lead author.

FDA: Deaths Following Intragastric Balloon Placement for Obesity

Two additional reports of death within the same time period may possibly be related to balloon placement as well.

FDA: Herbal Remedy Linked to High Lead Levels, Developmental Delay in Child

The risk of lead poisoning was initially communicated by the North Carolina Division of Public Health who tested the product and found high levels of lead.

New Treatment Option for Hereditary Tyrosinemia Type 1 Approved

The safety and efficacy of Nityr have been established based on studies of another oral formulation of nitisinone in patients with HT-1.

FDA Approves Kalydeco to Treat More Patients with Cystic Fibrosis

Today's FDA approval follows the Agency's recent approval for 23 other residual function mutations based on in vitro data.

First-in-Class Drug for Primary Hyperoxaluria Gets Orphan Drug Designation

The Orphan Drug designation was supported by data from preliminary studies showing that ALLN-177 significantly decreased urinary and plasma oxalate in several rodent and porcine models.

High-Dose Vitamin D May Benefit Skin After Sunburn

The study found that subjects who took the highest doses of vitamin D had long-term benefits, including reduced skin inflammation 48 hours after the burn.

SOBI003 Gains Orphan Drug Status for Rare Metabolic Disorder

According to the Company, SOBI003 is currently in the late pre-clinical phase and its first clinical trial is expected to commence in 2018.

Panhematin Available in New Dosage Strength

The new dosage strength better meets the required dose of most patients with acute intermittent porphyria.

Biomarin Submits BLA for New Phenylketonuria Therapy

The investigational drug is intended to substitute the deficient PAH enzyme with a PEGylated phenylalanine lyase enzyme to break down Phe.

Is Chocolate the New 'Brain Food'?

"Collectively, these findings seem to support quite consolidated epidemiological evidence indicating that regular cocoa flavanols intake possesses the potential to protect human cognition, particularly in aged populations," write the authors.

Obesity May Increase Influenza Risk Among Vaccinated Patients

The researchers assessed the relative risk for influenza and ILI on the basis of body mass index and determined seroconversion and seroprotection rates using pre-vaccination and 26-35 day post-vaccination serum samples.

Novel Synthetic Bio Drug for Hyperammonemia Granted Fast Track

Synthetic Biotic medicines utilize synthetic biology to reprogram probiotic bacteria to perform critical functions that compensate for those missing or damaged due to a particular disease.

Potential Microbial Growth Prompts Recall of Several Injectable Solutions

The affected lots were distributed in the U.S, Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore between January to June 2017.

What Happens When Descriptive Labeling Is Used for Vegetables?

Stanford University researchers changed the labeling on the serving bowls of a different vegetable each day for the 2016 autumn academic quarter.

Vitamin D, Omega-3s May Boost DMARD Response in Early RA

The researchers aimed to evaluate the association between dietary vitamin D, omega-3 fatty acids, and treatment outcomes with DMARDs in patients with rheumatoid arthritis.

Prebiotics May Help Cut Body Fat in Overweight, Obese Kids

At the conclusion of the study period, results showed that the once-daily prebiotic demonstrated significant benefit vs. placebo in change of percent body fat (-2.4% vs. +0.05%) and body weight z-score (-3.1% vs. +0.5%).

Acute Hepatic Porphyria Therapy Gets Breakthrough Designation

Currently, the only approved treatment for AHP attacks is hemin for injection (Panhematin or Normosang).

Sildenafil, Tadalafil Found in Herbal Coffee Supplement

These undeclared ingredients may interact with nitrates contained in some prescription medications (eg, nitroglycerin), and may decrease blood pressure to dangerous levels.

Severe Bronchial Injury Following Iron Pill Aspiration

The patient presented to the emergency department 12 hours after choking while taking her iron supplement.

Recall: Allergy Supplement Found to Contain Ephedra

Al-Er-G was marketed as a supplement for the relief of allergies.

FDA Approves Final Label for Syndros with CII Designation

Syndros is the first FDA-approved dronabinol solution for oral administration, containing the pharmaceutical version of tetrahydrocannabinol (THC).

AZO Line Expands with New Bladder Control Supplement

The supplement contains pumpkin seed and soy germ extract, and Synetrim CQ, a botanical that further promotes bladder control by aiding metabolic health and managing weight.

FDA: Anabolic Steroid-Like Substance Found in Dietary Supplement

The FDA found that Tri-Ton contains andarine and ostarine, selective androgen receptor modulators (SARMs), which are considered unapproved ingredients.

AAP: Policy Statement Regarding Fruit Juice Consumption

The AAP also states that human milk or infant formula is sufficient for infants whereas low-fat/nonfat milk and water are sufficient for older children.

FDA Expands Use of Kalydeco for Cystic Fibrosis

The FDA's decision was based on analyses of in vitro data and real-world clinical data spanning over five years on the safety and efficacy of Kalydeco.

Novel Treatment for IgG4-Related Disease Gains Orphan Drug Status

There is currently no approved treatment for lgG4-RD, which is a newly recognized disorder and is estimated to affect 40,000 individuals in the U.S.

Enzyme May Make Some Foods 'Safer' For Gluten-Sensitive

However the authors emphasized that the enzyme was not tested and is not recommended for use in patients with celiac disease, as even a small amount of gluten can inflict long-term damage in these patients.

FDA: Anabolic Steroids ID'd in Dietary Supplement

The product was distributed between February 2, 2015 to May 2, 2017. The Company is notifying its retailers and customers via a formal recall notice and is arranging for return of all impacted products.

Important Information for Clinicians Prescribing Sucraid

The FDA is recommending that clinicians prioritize access to the unapproved lot of Sucraid for patients with severe CSID and for patients with evidence of malnutrition.

Is Alternate-Day Fasting Better for Weight Loss?

The study authors observed that participants in the daily calorie restriction group achieved their prescribed energy goals whereas participants in the alternate-day fasting group ate more than prescribed on their "fast"days and ate less than prescribed on their "feast" days.

Vitamin D Review Looks at Risk Factors for Deficiency, Treatment Protocols

Protection against skin cancer is important but "moderate levels of unprotected sun exposure can be very helpful in boosting vitamin D."

Long-Term Weight Management Data Reported for Saxenda

These findings further confirm the safety profile of Saxenda and are comparable to the safety data seen at 56 weeks.

Certain Foods Tied to Increased Depression Risk

Which foods put patients at greater risk?

FDA Cracking Down on Cancer 'Cures'

Some of these products have been found to present a direct health risk to consumers.

FDA Discovers Active Drugs in Several Supplements, Orders Recall

The nationwide recall was ordered after analysis showed the contents of these supplements contained active pharmaceutical ingredients that may pose a threat to consumers.

Avocado May Benefit in Metabolic Syndrome

Researchers conducted a review of 129 articles concerning avocado consumption.

Combo Tx Significantly Improves Lung Function in Cystic Fibrosis Study

Results showed that the ivacaftor/tezacaftor group reached the primary endpoint with a mean absolute improvement in ppFEV1 of 4% points from baseline vs. placebo (P<0.0001).

No CVD Benefits with Multivitamin Use for Patients with Poor Diets

The data revealed "no consistent evidence of effect modification by various foods, nutrients, dietary patterns, or baseline supplement use" with multivitamin use on cardiovascular disease outcomes.

First Consumer Genetic Health Risk Tests Get FDA Approval

While the GHR tests may provide genetic risk information, they cannot determine a person's overall risk for developing a disease, as other factors beyond genetics (ie, environment, lifestyle) may also influence risk.

Amount of Vitamin D Needed May Be Less than What's Recommended

"This has important ramifications for public health recommendations," said Christopher Gallagher, MD, professor and director of the Bone Metabolism Unit in the Division of Endocrinology of Creighton University School of Medicine.

CDC: Daily Sodium Intake in U.S. Still High

Hypertension, a known risk factor for cardiovascular disease, can be managed by reducing sodium intake to lower blood pressure.

Vit C and the Common Cold: What's the Optimal Dose?

Study authors concluded that a "significant dose-response relationship" existed between the vitamin C dose and duration of the common cold.

Ryanodex Gets Priority Review for Exertional Heat Stroke

The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of Ryanodex (dantrolene sodium; Eagle) for the treatment of exertional heat stroke (EHS).

Weight-Loss Drug May Help in Opiate Addiction

For this study, the researchers trained rats to self-administer oxycodone while exposed to certain lights and sounds that produced a drug-taking environment.

Vit D Levels May Correlate With Overall Survival in Breast CA

The researchers found that the overall survival was strongest among premenopausal women in the highest 25OHD tertile group.

DEA Designates Syndros as Schedule II Drug

Syndros is anticipated to launch in the second half of 2017. It will be available as a 5mg/mL strength oral solution.

Judge Halts Operations of Three Dietary Supplement Companies

The Food and Drug Administration (FDA) determined that the dietary supplement products were misbranded and unapproved new drugs, as they were being marketed with drug claims despite receiving any such approvals.

Poor Diet Choices Linked to Over 400,000 U.S. Deaths in 2015

Looking at deaths in the United States from cardiovascular disease for 2015, the investigators found unhealthy diet choices and lack of eating healthier foods had a part in the deaths of 222,100 men and 193,400 women.

Water Consumption and Weight Loss: What's the Link?

Researchers compared two weight-loss diets in adolescents who were overweight or obese, either with or without additional advice and behavioral support to increase regular water uptake to 8 cups daily.

Storage Update for Orfadin Capsules

The FDA has approved the supplemental new drug applicationfor Orfadin (nitisinone capsules; Sobi) which allows for an extension of shelf life for the 20mg capsules from 24 months to 36 months.

FDA Grants Orphan Drug Status to Rare Lysosomal Storage Disorder Treatment

The FDA has granted Orphan Drug designation to Sangamo's genome editing product candidate, SB-913, for the treatment of Mucopolysaccharidosis Type II (MPS II).

AGA Releases Obesity Practice Guide

The American Gastroenterological Association (AGA) has released an 'Obesity Practice Guide', providing gastroenterologists with a comprehensive, multi-disciplinary process to lead safe and effective weight management for obese patients.

Can Vitamin D Supplementation Protect Against Acute Respiratory Infection?

To assess the efficacy of vitamin D in suppressing acute respiratory infections, researchers analyzed results from 25 randomized controlled trials which included over 11,000 participants.

Unapproved Weight Loss Injectable Recalled

Recall of Human Chorionic Gonadotropin vials occurred due to a lack of sterility assurance. The product is not approved by the FDA for any other over-the-counter indication.

Vitamin B12 Monitoring May Be Lacking Among Long-Term Metformin Users

According to a study published in the Journal of the American Geriatrics Society, long-term metformin use is significantly associated with lower serum vitamin B12 levels, but those at risk often are not monitored for this deficiency.

Omega-3 Fatty Acids and Asthma: Why Do Outcomes Vary?

Omega-3 fatty acids contained in fish oil was shown to have a lowering effect on lgE production (the antibodies which fuel asthma), suggesting that omega-3 fatty acids may be utilized to treat asthma patients.

Exposure to Common Plastic Compound May Increase Offspring Obesity Risk

Prenatal exposure to bisphenol A (BPA) may raise a child's risk of obesity by altering hypothalamic circuits that regulate feeding behavior and energy balance, according to an experimental study published online Feb. 7 in Endocrinology.

FDA Approves Screening System that Detects Metabolic Disorders in Newborns

The Food and Drug Administration has approved the marketing of the Seeker System (Baebies, Inc.) for the screening of four rare lysosomal storage disorders (LSDs) in newborns.

Clinical Guidelines Set Primary Goals for Preventing Pediatric Obesity

In a clinical practice guideline published online in the Journal of Clinical Endocrinology and Metabolism, recommendations are presented for the assessment, treatment, and prevention of pediatric obesity.

Herb, Supplement Use Up Among Pregnant Women

From 2002 to 2012 there was an increase in herb and supplement use among pregnant women, according to a research letter published in the American Journal of Obstetrics and Gynecology.

Children with Transverse Myelitis Should Be Screened for Celiac Disease

Transverse myelitis (TM) can be a manifestation of celiac disease (CD) in young children, according to a case report published online February 2 in Pediatrics.

Psychostimulants Assessed as Possible Bulimia Nervosa Treatment

For select patients, psychostimulants may be beneficial for treating bulimia nervosa, according to a study of six cases published online January 23 in the Journal of Clinical Pharmacology.

AHA: Meal Frequency, Timing May Affect Cardiovascular Health

A new statement from the American Heart Association (AHA), published online in Circulation, highlights what's known - and what's not - about meal timing and cardiovascular health.

Endocrine Society Releases New Guideline for Pediatric Obesity

The Endocrine Society released an updated evidence-based clinical practice guideline on the prevention and treatment of childhood obesity with lifestyle changes.

Adherence to Mediterranean Diet May Lower ADHD Risk

Children who follow a Mediterranean diet may be less likely to have attention-deficit/hyperactivity disorder (ADHD), according to a study published online January 30 in Pediatrics.

Can Limiting Weight Gain During Pregnancy Lower Complication Risk in Obese?

Strategies to help overweight or obese women limit their weight gain during pregnancy don't seem to alleviate the risk for obstetric complications, according to a study presented at the annual meeting of the Society for Maternal-Fetal Medicine, The Pregnancy Meeting.

Sedentary Lifestyle Precursor to Prediabetes Regardless of Weight

Inactivity is associated with greater risk of prediabetes and diabetes, even for healthy-weight adults, according to a study published online in the American Journal of Preventive Medicine.

Weight Loss and Reductions in Sleepiness: A Causal Relationship?

For overweight or obese adults, intentional weight loss is associated with improvement in daytime sleepiness, according to a review published online in Obesity Reviews.

CDC Reports on Sugary Drink Consumption Among Youth

Nearly two-thirds of boys and girls ages 2 to 19 in the United States drink at least one sugar-sweetened beverage daily, according to a January data brief published by the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics (NCHS).

High-Inflammation Diets May Impact Fracture Risk

An anti-inflammatory diet may protect women against bone density loss and decrease the risk of hip fracture, according to data taken from the Women's Health Initiative (WHI).

Some Nutraceuticals Found to Improve Outcomes in Heart Failure

Supplementing with certain nutraceuticals could be beneficial for patients with heart failure, according to a new review published in Current Pharmaceutical Design.

Managing SSTIs in Obese Patients: Which Treatments Are Optimal?

When treating skin and soft tissue infections (SSTIs) in obese patients, the pharmacokinetic/pharmacodynamic approach offers important data and decision-making tools for optimizing regimens used for both prevention and treatment of SSTIs in this population.

Does Green Tea Consumption Impact Medication Metabolism?

Consuming green tea (Camellia sinensis) extract or its associated catechins is not expected to have a clinically significant impact on major CYP450 or uridine 5'diphospho-glucuronosyltransferase enzyme substrates or P-glycoprotein (P-gp) substrates, study authors concluded in a review published in Planta Medica.

Can Physician-Delivered Step Count Goal Improve Real World Outcomes?

A physician-delivered step count prescription strategy with an individualized rate of increase can result in an increase in step count/day, according to a study published online January 11 in Diabetes, Obesity and Metabolism.

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).