La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos - FDA Press Releases

La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos

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FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles - FDA Press Releases

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

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Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma - FDA Safety Alerts & Drug Recalls

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FDA) approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year COMPASS study. The COMPASS study demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in subjects implanted with the CyPass Micro-Stent at the time of cataract surgery, as compared to subjects undergoing cataract surgery alone. At two years post-surgery, there was little difference in endothelial cell loss between the CyPass Micro-Stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss.1, 2

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FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food - FDA Press Releases

FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

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District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs - FDA Press Releases

The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings - FDA Press Releases

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

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Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination - FDA Safety Alerts & Drug Recalls

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table below) that were manufactured at the King Bio, Inc facility in Asheville, NC.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law

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Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination - FDA Safety Alerts & Drug Recalls

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.

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Cytotoxic antibiotic angucyclines and actinomycins from the Streptomyces sp. XZHG99T - Journal of Antibiotics

Cytotoxic antibiotic angucyclines and actinomycins from the Streptomyces sp. XZHG99T

Cytotoxic antibiotic angucyclines and actinomycins from the <i>Streptomyces</i> sp. XZHG99T, Published online: 29 August 2018; doi:10.1038/s41429-018-0096-1

Cytotoxic antibiotic angucyclines and actinomycins from the Streptomyces sp. XZHG99T

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Quinohemanine, a quinoxalinone-bohemamine hybrid compound from Streptomyces sp. CPCC 200497 - Journal of Antibiotics

Quinohemanine, a quinoxalinone-bohemamine hybrid compound from Streptomyces sp. CPCC 200497

Quinohemanine, a quinoxalinone-bohemamine hybrid compound from <i>Streptomyces</i> sp. CPCC 200497, Published online: 29 August 2018; doi:10.1038/s41429-018-0084-5

Quinohemanine, a quinoxalinone-bohemamine hybrid compound from Streptomyces sp. CPCC 200497

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Reversible Dementias - Geriatrics

As the worldwide prevalence of dementia increases, there is a greater and more urgent need for all health care providers to understand how to evaluate and manage cognitive impairment. Many people presenting with a dementing illness have one or more reversible underlying conditions that worsen prognosis and, if treated, can improve cognitive function. This article reviews the major potentially reversible dementias, including the basic workup and management of each condition.

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Consumer Alert - Undeclared Sulfites in “Lily Bulb” - FDA Safety Alerts & Drug Recalls

New York State Agriculture Commissioner Richard A. Ball today alerted consumers that the “Lily Bulb” product (photo attached) distributed by Allied Imports Inc. of 267 52nd Street, Brooklyn, NY 11220 was found to contain sulfites, which are not declared on the product label. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product. No illnesses have been reported to date to this Department in connection with this product.

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Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle - FDA Safety Alerts & Drug Recalls

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

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Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination - FDA Safety Alerts & Drug Recalls

Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.

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FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products - FDA Press Releases

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

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FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales - FDA Press Releases

FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

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King Bio Issues Voluntary Nationwide Recall of All Aqueous-Based Products for Human and Animal Use Due to Possible Microbial Contamination - FDA Safety Alerts & Drug Recalls

King Bio is voluntarily recalling all of its aqueous-based products for human and animal use (see website link below), within expiry, to the consumer level due to possible microbial contamination.

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Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up - FDA Safety Alerts & Drug Recalls

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

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Nutrition and Alzheimer Disease - Geriatrics

We gathered some theoretic and practical concepts related to the importance of nutrition in the prevention and management of Alzheimer disease (AD). Besides the role of nutrients in brain development and functioning, some nutrients exert special control in the development of AD, due to their participation in neurotransmitter synthesis, their modulation in epigenetics mechanisms, and as antioxidants. In addition, some non-nutrient food–derived substances have shown potential in the control of neuroinflammation and consequently in the prevention of AD. Finally, it is important to be aware of the nutritional status and food intake patterns of the patient with AD.

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Behavioral Problems and Dementia - Geriatrics

Behavioral problems decrease quality of life of people with dementia and their care providers. Three main consequences of dementia are functional impairment and in some cases also mood disorders and psychosis. These consequences, alone or in combination, result in 3 main behavioral problems: apathy, agitation, and rejection of care/aggression. Nonpharmacologic management strategies include meaningful activities and individualized comfort care, for example, Namaste Care. If needed, pharmacologic management should concentrate on treatment of main dementia consequences, especially depression, instead of treating secondary symptoms, for example, insomnia. Use of antipsychotics should be minimized but antipsychotics may be necessary for augmentation of antidepressants.

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Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings - FDA Press Releases

FDA announced that all 17 manufacturers, distributors, and retailers that were warned in May have stopped selling the e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products.

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Paper-based luminescence bioassay method embedding a sequence of enzymatic reactions to detect sulfonamide groups - Journal of Antibiotics

Paper-based luminescence bioassay method embedding a sequence of enzymatic reactions to detect sulfonamide groups

Paper-based luminescence bioassay method embedding a sequence of enzymatic reactions to detect sulfonamide groups, Published online: 23 August 2018; doi:10.1038/s41429-018-0094-3

Paper-based luminescence bioassay method embedding a sequence of enzymatic reactions to detect sulfonamide groups

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FDA approves first drug for neurotrophic keratitis, a rare eye disease - FDA Press Releases

FDA approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

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King Bio Issues Voluntary Nationwide Recall of It’s Kids and Infant Products Due to Potential Microbial Contamination - FDA Safety Alerts & Drug Recalls

King Bio is voluntarily recalling the below products to the consumer level. A small percentage of our products produced between 08/01/2017 and 04/2018 have tested positive for microbial contamination. Out of an abundance of caution, we are recalling the products and lot numbers below

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Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics - FDA Press Releases

FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine to advance the development of evidence-based, indication-specific guidelines to help guide appropriate opioid prescribing.

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Traumatic Brain Injury, Chronic Traumatic Encephalopathy, and Alzheimer Disease - Geriatrics

Traumatic brain injury (TBI) is a major health and economic burden. With increasing aging population, this issue is expected to continue to rise. Neurodegenerative disorders are more common with aging population in general regardless of history of TBI. Recent evidence continues to support a relation between a TBI and neurocognitive decline later in life (such as in athletes and military). This article summarizes the pathologic and clinical effects of TBI (regardless of severity) on the later development of dementia in individuals 65 years or older.

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Lewy Body Dementia - Geriatrics

Dementia with Lewy bodies (DLB) is the second most common neurodegenerative dementia following Alzheimer disease. It stems from the formation of Lewy bodies, which contain aggregates of the misfolded protein, α-synuclein. These deposit in areas of the nervous system and brain, leading to neuronal cell death and causing clinically apparent symptoms. Because of its clinical overlap with other forms of dementia, DLB is often underdiagnosed and misdiagnosed. There is currently no cure for DLB and treatments are aimed at ameliorating specific symptoms.

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Alzheimer Disease - Geriatrics

Alzheimer disease is due to increased amyloid-β coupled with low progranulin. Several brain imaging techniques are helpful in the diagnosis. Drugs available for treating Alzheimer disease have limited clinical utility. Cognitive stimulation therapy is an effective therapy for persons with moderate Alzheimer disease.

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Mild Cognitive Impairment in Geriatrics - Geriatrics

Mild cognitive impairment remains a clinical diagnosis, aided by history, neurologic examination, screening mental status examination, and secondary testing. It can be difficult to distinguish from normal aging without understanding a patient’s prior level of intellectual function and new complaint. Geriatricians encounter patients with mild cognitive impairment in all long-term care settings. Making the diagnosis allows patients and their families to understand limits and develop strategies to maximize function. Etiologies associated with mild cognitive impairment include degenerative and vascular processes, psychiatric causes, and comorbid medical conditions. Treatable medical conditions may also present as mild cognitive impairment and have reversible outcomes.

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An Overview of Cognitive Impairment - Geriatrics

Cognitive decline occurs in all persons during the aging process. Eventually, this can result in mild cognitive impairment and dementia. There are more than 100 causes of dementia. A multifocal approach to slowing cognitive decline (Mediterranean diet, exercise, computer games, socialization, and treatment of cardiovascular risk factors) appears to be effective.

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Isolation and structural elucidation of pelgipeptin E, a novel pore-forming pelgipeptin analog from Paenibacillus elgii with low hemolytic activity - Journal of Antibiotics

Isolation and structural elucidation of pelgipeptin E, a novel pore-forming pelgipeptin analog from Paenibacillus elgii with low hemolytic activity

Isolation and structural elucidation of pelgipeptin E, a novel pore-forming pelgipeptin analog from <i>Paenibacillus elgii</i> with low hemolytic activity, Published online: 22 August 2018; doi:10.1038/s41429-018-0095-2

Isolation and structural elucidation of pelgipeptin E, a novel pore-forming pelgipeptin analog from Paenibacillus elgii with low hemolytic activity

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Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk - FDA Safety Alerts & Drug Recalls

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

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UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets - FDA Safety Alerts & Drug Recalls

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

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Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Lipari Foods, LLC has issued a voluntary recall of Premo Brand turkey and cheese wedge sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Cognitive Stimulation Therapy for Dementia - Geriatrics

Cognitive stimulation therapy has proven to be both an effective and enjoyable psychological treatment for people with dementia. Over the past 20 years, cognitive stimulation therapy has grown from a national, localized treatment in the UK to a more global phenomenon currently being used in more than 25 countries around the world. Much has been accomplished during the cognitive stimulation therapy journey and there is still much to be explored; it is a dynamic field. This article provides an overview of cognitive stimulation therapy by elaborating on its background, evidence, international work, and future directions.

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A choline binding polypeptide of LytA inhibits the growth of Streptococcus pneumoniae by binding to choline in the cell wall - Journal of Antibiotics

A choline binding polypeptide of LytA inhibits the growth of Streptococcus pneumoniae by binding to choline in the cell wall

A choline binding polypeptide of LytA inhibits the growth of <i>Streptococcus pneumoniae</i> by binding to choline in the cell wall, Published online: 20 August 2018; doi:10.1038/s41429-018-0091-6

A choline binding polypeptide of LytA inhibits the growth of Streptococcus pneumoniae by binding to choline in the cell wall

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A role of uroleuconaphins, polyketide red pigments in aphid, as a chemopreventor in the host defense system against infection with entomopathogenic fungi - Journal of Antibiotics

A role of uroleuconaphins, polyketide red pigments in aphid, as a chemopreventor in the host defense system against infection with entomopathogenic fungi

A role of uroleuconaphins, polyketide red pigments in aphid, as a chemopreventor in the host defense system against infection with entomopathogenic fungi, Published online: 20 August 2018; doi:10.1038/s41429-018-0093-4

A role of uroleuconaphins, polyketide red pigments in aphid, as a chemopreventor in the host defense system against infection with entomopathogenic fungi

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Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets - FDA Safety Alerts & Drug Recalls

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

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FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder - FDA Press Releases

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

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Novel desferrioxamine derivatives synthesized using the secondary metabolism-specific nitrous acid biosynthetic pathway in Streptomyces davawensis - Journal of Antibiotics

Novel desferrioxamine derivatives synthesized using the secondary metabolism-specific nitrous acid biosynthetic pathway in Streptomyces davawensis

Novel desferrioxamine derivatives synthesized using the secondary metabolism-specific nitrous acid biosynthetic pathway in <i>Streptomyces davawensis</i>, Published online: 17 August 2018; doi:10.1038/s41429-018-0088-1

Novel desferrioxamine derivatives synthesized using the secondary metabolism-specific nitrous acid biosynthetic pathway in Streptomyces davawensis

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Evaluation of LL-37 antimicrobial peptide derivatives alone and in combination with vancomycin against S. aureus - Journal of Antibiotics

Evaluation of LL-37 antimicrobial peptide derivatives alone and in combination with vancomycin against S. aureus

Evaluation of LL-37 antimicrobial peptide derivatives alone and in combination with vancomycin against <i>S. aureus</i>, Published online: 17 August 2018; doi:10.1038/s41429-018-0090-7

Evaluation of LL-37 antimicrobial peptide derivatives alone and in combination with vancomycin against S. aureus

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FDA approves first generic version of EpiPen - FDA Press Releases

FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans - FDA Press Releases

FDA announces workshop on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on significant public health value and cost savings resulting from the agency’s youth smoking prevention campaign - FDA Press Releases

A cost-effectiveness analysis of the FDA’s “The Real Cost” youth smoking prevention campaign shows it has resulted in savings of more than $31 billion for youth, their families and society at large.

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Zakah Life Recalls Kratom Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Marsee Baking Issues Allergy Alert On Undeclared Peanuts In Cookies Sold At Café Yumm! Restaurants - FDA Safety Alerts & Drug Recalls

Marsee Foods, Inc. dba Marsee Baking is voluntarily recalling chocolate chip, ginger spice, and oatmeal raisin cookies sold at Café Yumm! restaurants. The cookies may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Cognitive Frailty in Geriatrics - Geriatrics

Since the operational definition of “cognitive frailty” was proposed in 2013 by the International Academy of Nutrition and Aging and the International Association of Gerontology and Geriatrics, several studies have shown the prevalence and outcomes of cognitive frailty. The prevalence of cognitive frailty is quite low in the community settings when the original definition is applied, but higher in clinical settings. In longitudinal studies, cognitive frailty is a risk for disability, poor quality of life, dementia, and death. For cognitive frailty, multimodal interventions would be effective to reduce the risk of adverse health outcomes in older people.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide in support of responsible opioid prescribing for safe, effective pain management in animals

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Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts - FDA Safety Alerts & Drug Recalls

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

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Pullusurfactans A–E, new biosurfactants produced by Aureobasidium pullulans A11211-4-57 from a fleabane, Erigeron annus (L.) pers. - Journal of Antibiotics

Pullusurfactans A–E, new biosurfactants produced by Aureobasidium pullulans A11211-4-57 from a fleabane, Erigeron annus (L.) pers.

Pullusurfactans A–E, new biosurfactants produced by <i>Aureobasidium pullulans</i> A11211-4-57 from a fleabane, <i>Erigeron annus</i> (L.) pers., Published online: 15 August 2018; doi:10.1038/s41429-018-0089-0

Pullusurfactans A–E, new biosurfactants produced by Aureobasidium pullulans A11211-4-57 from a fleabane, Erigeron annus (L.) pers.

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Pyroxazone, a new neuroprotective compound from Streptomyces sp. RAN54 - Journal of Antibiotics

Pyroxazone, a new neuroprotective compound from Streptomyces sp. RAN54

Pyroxazone, a new neuroprotective compound from <i>Streptomyces</i> sp. RAN54, Published online: 15 August 2018; doi:10.1038/s41429-018-0085-4

Pyroxazone, a new neuroprotective compound from Streptomyces sp. RAN54

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World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads Contamination - FDA Safety Alerts & Drug Recalls

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful Remedies Gold Series Ultra Enhanced Indo and Blissful Remedies Kratom+CBD, CBD infused Maeng Da, Red Maeng Da 100% Mitragyna Speciosa, recalled due to Salmonella contamination, where Blissful Remedies was listed as the recalling firm instead of World Organix LLC. To date, World Organix LLC has not received reports of adverse events related to these recalls.

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Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration - FDA Safety Alerts & Drug Recalls

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Manufacturing Practices (cGMP). Substandard cGMP practices could represent the possibility of risk being introduced into the manufacturing process.

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FDA approves new treatment for a rare genetic disorder, Fabry disease - FDA Press Releases

FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

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FDA approves new vaginal ring for one year of birth control - FDA Press Releases

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

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FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease - FDA Press Releases

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

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FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy - FDA Press Releases

The app uses basal body temperature readings to predict when a woman is most fertile to help her avoid conceiving on those days if using as a form of contraception

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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API) - FDA Safety Alerts & Drug Recalls

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

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"Country Favor Inc Issues Alert on Undeclared Sulfites in “Best Taste Brand Snack Ginger Sliced” - FDA Safety Alerts & Drug Recalls

Country Favor Inc. of Maspeth, New York is recalling its 7 ounce packages of “Best Taste Brand Snack Ginger Sliced” food treats because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

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FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests - FDA Press Releases

FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

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Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination - FDA Safety Alerts & Drug Recalls

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

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FDA approves treatment for two rare types of non-Hodgkin lymphoma - FDA Press Releases

FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy

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FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs - FDA Press Releases

FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition

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Aplasmomycin and boromycin are specific inhibitors of the futalosine pathway - Journal of Antibiotics

Aplasmomycin and boromycin are specific inhibitors of the futalosine pathway

Aplasmomycin and boromycin are specific inhibitors of the futalosine pathway, Published online: 08 August 2018; doi:10.1038/s41429-018-0087-2

Aplasmomycin and boromycin are specific inhibitors of the futalosine pathway

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Acremotins A–D, peptaibiotics produced by the soil-derived fungus Acremonium persicinum SC0105 - Journal of Antibiotics

Acremotins A–D, peptaibiotics produced by the soil-derived fungus Acremonium persicinum SC0105

Acremotins A–D, peptaibiotics produced by the soil-derived fungus <i>Acremonium persicinum</i> SC0105, Published online: 08 August 2018; doi:10.1038/s41429-018-0086-3

Acremotins A–D, peptaibiotics produced by the soil-derived fungus Acremonium persicinum SC0105

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Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen - FDA Safety Alerts & Drug Recalls

Mojave Foods Corporation is initiating a voluntary recall of four sizes of El Guapo Jamaica Hibiscus Flower packages in flexible packaging due to an unlabeled peanut allergen

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G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk - FDA Safety Alerts & Drug Recalls

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

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FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder - FDA Press Releases

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

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Voluntary Recall of Hostess Cookies 'n Creme Brownies - FDA Safety Alerts & Drug Recalls

Hostess Brands, LLC has become aware that the "Contains" statement on Hostess Cookies 'n Creme Brownies does not list "egg" as an allergen. Although the ingredient list on the packaging identifies "egg" as an ingredient, the "Contains" statement, which is designed to further alert consumers of allergens in the products, does not include "egg".

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes - FDA Press Releases

FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval as new drugs.

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HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen - FDA Safety Alerts & Drug Recalls

HP Hood LLC is voluntarily recalling a limited number of half-gallon (1.89 L) cartons of refrigerated Vanilla Almond Breeze almond milk because the product may contain milk, an allergen not listed on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The product is safe to consume unless you have a milk allergy or sensitivity. To date, there has been one report of an allergic reaction. Medical treatment or hospitalization was not required.

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Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging - FDA Safety Alerts & Drug Recalls

Sweet Earth Foods is initiating a voluntary recall of a limited amount of 8-ounce packages of Sweet Earth Aloha BBQ Quesadilla due to mismatched packaging, resulting in undeclared egg and milk allergens. People who are allergic to eggs or milk could have a serious or life- threatening reaction if they consume this item. A UPC code of 016741000551 appears on the back of the package. The “best by” date of 6/28/19 and lot number of 8149 appears on the side of the package.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

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