This case demonstrates how important it is for clinicians to be able to identify dietary supplements that can lead to dangerous drug-drug interactions.
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.
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.
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.
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.
Two additional reports of death within the same time period may possibly be related to balloon placement as well.
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.
The safety and efficacy of Nityr have been established based on studies of another oral formulation of nitisinone in patients with HT-1.
Today's FDA approval follows the Agency's recent approval for 23 other residual function mutations based on in vitro data.
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.
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.
According to the Company, SOBI003 is currently in the late pre-clinical phase and its first clinical trial is expected to commence in 2018.
The new dosage strength better meets the required dose of most patients with acute intermittent porphyria.
The investigational drug is intended to substitute the deficient PAH enzyme with a PEGylated phenylalanine lyase enzyme to break down Phe.
"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.
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.
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.
The affected lots were distributed in the U.S, Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore between January to June 2017.
Stanford University researchers changed the labeling on the serving bowls of a different vegetable each day for the 2016 autumn academic quarter.
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.
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%).
Currently, the only approved treatment for AHP attacks is hemin for injection (Panhematin or Normosang).
These undeclared ingredients may interact with nitrates contained in some prescription medications (eg, nitroglycerin), and may decrease blood pressure to dangerous levels.
The patient presented to the emergency department 12 hours after choking while taking her iron supplement.
Al-Er-G was marketed as a supplement for the relief of allergies.
Syndros is the first FDA-approved dronabinol solution for oral administration, containing the pharmaceutical version of tetrahydrocannabinol (THC).
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.
The FDA found that Tri-Ton contains andarine and ostarine, selective androgen receptor modulators (SARMs), which are considered unapproved ingredients.
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.
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.
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.
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.
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.
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.
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.
Protection against skin cancer is important but "moderate levels of unprotected sun exposure can be very helpful in boosting vitamin D."
These findings further confirm the safety profile of Saxenda and are comparable to the safety data seen at 56 weeks.
Some of these products have been found to present a direct health risk to consumers.
The nationwide recall was ordered after analysis showed the contents of these supplements contained active pharmaceutical ingredients that may pose a threat to consumers.
Researchers conducted a review of 129 articles concerning avocado consumption.
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).
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.
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.
"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.
Hypertension, a known risk factor for cardiovascular disease, can be managed by reducing sodium intake to lower blood pressure.
Study authors concluded that a "significant dose-response relationship" existed between the vitamin C dose and duration of the common cold.
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).
For this study, the researchers trained rats to self-administer oxycodone while exposed to certain lights and sounds that produced a drug-taking environment.
The researchers found that the overall survival was strongest among premenopausal women in the highest 25OHD tertile group.
Syndros is anticipated to launch in the second half of 2017. It will be available as a 5mg/mL strength oral solution.
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.
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.
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.
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.
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).
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
The Endocrine Society released an updated evidence-based clinical practice guideline on the prevention and treatment of childhood obesity with lifestyle changes.
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.
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.
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.
For overweight or obese adults, intentional weight loss is associated with improvement in daytime sleepiness, according to a review published online in Obesity Reviews.
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).
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).
Supplementing with certain nutraceuticals could be beneficial for patients with heart failure, according to a new review published in Current Pharmaceutical Design.
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.
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.
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.
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).
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.
The Food and Drug Administration (FDA) has granted Orphan Drug designation for Concert Pharmaceuticals' CTP-656 (deuterated ivacaftor) for the treatment of cystic fibrosis.
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.
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.
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.
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.
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.
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.
The 47-year-old previously fit woman presented to the hospital following a short period of confusion and repetitive behavior.
A laboratory analysis found the presence of Variovorax paradoxus.
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.
Bioberica announced positive results from the MOSAIC Study that evaluated the use of chondroitin sulfate for knee osteoarthritis.
Orexigen Therapeutics announced that data from the IGNITE study have been published in the journal Obesity.
The heart-healthy Mediterranean diet may also help preserve brain health in older adults, according to research published online in Neurology.
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.
Findings further support the evidence associating low vitamin D with increased risk of chronic diseases.
In 2012, the AACE described obesity as a disease state, which was officially adopted by the American Medical Association (AMA) in 2014.
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.
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.
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).