Homeopathic Products for Teething, Nausea, Colic, Cough Recalled

Recalled products include Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir.

FDA Committee in Favor of Waylivra for Rare Metabolic Lipid Disorder

Antisense technology refers to the use of synthetic nucleic acid sequences to interrupt specific protein production by targeting the corresponding messenger RNA that encodes that protein.

First FDA-Approved Treatment for X-Linked Hypophosphatemia Launched

Crysvita, a recombinant fully human monoclonal IgG1 antibody, works by blocking fibroblast growth factor 23 (FGF23), a hormone that causes phosphate urinary excretion and suppresses vitamin D production by the kidney.

Crysvita Approved for the Treatment of X-Linked Hypophosphatemia

Crysvita is an antibody that blocks fibroblast growth factor 23 (FGF23), a hormone that causes phosphate urinary excretion and suppresses active vitamin D production by the kidney.

FDA Cracks Down on Concentrated Caffeine Products

The FDA is prepared to take steps right away to begin removing illegal products from the market.

Iron Formulation and Cancer Risk: Is There a Link?

In the U.S., ferric citrate is commonly found in dietary supplements and ferric EDTA is often used as a food additive.

Elamipretide Granted Orphan Drug Status for Barth Syndrome

The TAZPOWER study is a randomized, double-blind, placebo-controlled Phase 2/3 crossover study evaluating the safety and efficacy of elamipretide (daily subcutaneous injections) in 12 male patients (aged ≥12 years) with genetically-confirmed Barth syndrome.

Novel Cystic Fibrosis Treatment Granted Fast Track Status

Proteostasis Therapeutics is developing the combination treatment which includes a novel transmembrane conductance regulator (CFTR) amplifier (PTI-428), a third generation corrector (PTI-801) and a potentiator (PTI-808).

Infant Formula Containing Milk Fat Globule Membrane Launched

Based on a clinical study, MFGM can help support cognitive development similar to breast milk.

Impact of Mediterranean Diet on Aging Examined

In general, researchers highlight 5 key adaptations seen with adhering to the Mediterranean diet pattern: Lipid lowering, protection from oxidative stress and inflammation, modification of growth factors that can promote cancer, Inhibition of nutrient sensing pathways by amino acid restriction, and gut microbiota-mediated production of metabolites.

Change in BMI During Puberty Tied to Later Heart Failure Risk

Compared with boys who were neither overweight during childhood or puberty, boys developing overweight during puberty had increased risk of heart failure.

Unique Vit B3 Formulation May Improve Blood Pressure, CV Health

NR supplementation showed reductions in mean systolic blood pressure (SBP; mean change -3.9mmHg) and diastolic blood pressure (DBP; mean change -2.0mmHg) for all patients; these findings were not statistically significant after adjusting for multiple comparisons.

Tiny Tooth Sensor Monitors Dietary Intake, Sends Info to a Mobile Device

When the central layer of the sensor comes in contact with 1 of the pre-defined nutrients (in the current case salt, glucose or alcohol), it's electrical properties change and the sensor absorbs and transmits a different spectrum of radio waves with varying intensity.

Can Omega-6 Fatty Acids Protect Against Premature Death, CV Disease?

After classifying patients into 5 groups based on their blood linoleic level, the researchers found a 43% reduced risk of premature death among those with the highest level when compared with the group with the lowest level (adjusted hazard ratio [HR] 0.57, 95% CI: 0.46, 0.71; P<0.00).

Significant Weight Loss Seen With Once-Daily Semaglutide in Obese Adults

Novo Nordisk is planning on initiating a Phase 3 trial of semaglutide that will include 4,500 individuals who are overweight or obese sometime in 2018. Semaglutide is currently not approved for treatment of obesity.

Oral vs. Intramuscular Vitamin B12: Efficacy, Safety Compared

Researchers from Beijing University of Chinese Medicine and the Catalan Health Institute, Spain sought to investigate the effects of oral vitamin B12 vs. IM vitamin B12 to determine whether outcomes for vitamin B12 deficient patients would differ based on the formulation.

First Herbal Supplement and Topical Duo Launched for Skin Conditions

Both Calm topical and Calm + Detox supplements do not contain any steroids, parabens, sulfates, preservatives, petroleum, tree nuts, and gluten.

Balanced Crystalloids May Cut Kidney Complications Compared With Saline

The results showed no difference in the number of hospital-free days between either group but the balanced crystalloids group had a lower incidence of major adverse kidney events ≤30 days vs the saline group.

Can Diet Adherence Help Cut Depression Risk in Adults?

The results showed that those participants who fell into the top group for DASH diet adherence had 11% lower odds of becoming depressed versus those in the lowest group of DASH adherence.

Cystic Fibrosis Combo Treatment Symdeko Gets FDA Approval

Symdeko is Vertex's third medicine approved to treat the underlying cause of CF.

'Gene Silencing' Drug Under FDA Review for Hereditary ATTR Amyloidosis

Patisiran has been granted Fast Track Designation, Breakthrough Therapy Designation, and an expanded Orphan Drug Designation for ATTR amyloidosis from the FDA.

Medical Food Used for Managing Osteoarthritis Recalled at FDA's Request

There have been no deaths reported with the use of Limbrel.

Significant Memory, Attention Benefits Associated With Curcumin Supplement

Significant changes in mean FDDNP were found at 18 months in the amygdala and hypothalamus regions of the brain, which control several memory and emotional functions.

Could a Widely Used Food Additive Be Contributing to Epidemic C. difficile?

Implementation of trehalose as a food additive into the human diet may have contributed to hypervirulence.

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).