MarcasUSA, LLC Emite Retiro Voluntariamente a Nivel Nacional de Pasta De Lassar Andromaco Protector de la Piel con 25% de óxido de Zinc, en Tubos de 60 Gramos, Debido a Contaminación Microbiana - FDA Safety Alerts & Drug Recalls

PARA PUBLICACIÓN INMEDIATA - 29 de marzo de 2018 - El Segundo, CA, MarcasUSA, LLC e Industria Farmacéutica Andromaco, S.A. de C.V. están retirando voluntariamente tres lotes de Pasta De Lassar Andromaco Protector de la Piel con 25% de óxido de zinc, en tubos de 60 gramos, al nivel minorista. El análisis de la FDA de este producto confirmó que Pasta De Lassar Andromaco está contaminado con altos niveles de bacterias y hongos. El lote específico asociado a los hallazgos positivos se puso en cuarentena y se destruyó, ninguna pieza fue vendida en los EE. UU. Sin embargo, debido a la cantidad y el tipo de contaminación, los tres lotes restantes en el mercado de los EE. UU. se retiran como una gran medida de precaución. El uso del producto contaminado podría aumentar el riesgo de infección. Hasta la fecha, MarcasUSA no ha recibido ningún informe de eventos adversos relacionados con este retiro del mercado.

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MarcasUSA, LLC Issues Voluntary Nationwide Recall of Pasta De Lassar Andromaco Skin Protectant 25% Zinc Oxide 60g Due to Potential Contamination - FDA Safety Alerts & Drug Recalls

FOR IMMEDIATE RELEASE – March 29, 2018 – El Segundo, CA, MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. is voluntarily recalling four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination the remaining four lots in the US market are being recalled out of an abundance of caution. Use of the contaminated product could result in an increased risk of infection. To date, MarcasUSA has not received any reports of adverse events related to this recall.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review - FDA Press Releases

FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review

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Health Nut Factory Recalls Organic Coconut Smiles Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Healthy Nut Factory of Bayside, NY is recalling 7 oz. Pouches of Organic Coconut Smiles because it has the potential to be 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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Target Corporation Issues a Voluntary Recall For a Variety of Frozen Products Sold at a Single Store on Oahu - FDA Safety Alerts & Drug Recalls

Target Corp. (NYSE: TGT) is voluntarily recalling a number of frozen items sold at a single Target store on Oahu located at 1450 Ala Moana Blvd., Honolulu, Hawaii. The products were not held at an appropriate temperature and may be contaminated by spoilage organisms or pathogens, which could lead to serious or life-threatening illness if consumed. The recall includes items listed here (Item Listlink)) that were sold on March 23, 2018 through March 27, 2018. No illnesses have been reported to date.

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FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse - FDA Press Releases

FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse

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Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA - FDA Press Releases

A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.

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Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs - FDA Press Releases

Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs

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First Source Issues Allergy Alert on Undeclared Peanuts in Wegmans 9 Oz Yogurt Raisins - FDA Safety Alerts & Drug Recalls

First Source of Tonawanda, NY, is voluntarily recalling 9 OZ packages of Wegmans Yogurt Raisins, because the product may contain undeclared peanuts. People who have an allergy or sensitivity to peanuts run the risk of serious or life- threatening allergic reaction if they consume this product.

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FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices - FDA Press Releases

The authorization classifies integrated continuous glucose monitoring devices in class II and subjects them to certain criteria called special controls

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eBars Issues Allergy Alert on Undeclared Allergens - FDA Safety Alerts & Drug Recalls

eBars LLC of Franklin, Tenn. is issuing a voluntary recall on its line of products that may contain undeclared peanut and/or almond allergens.

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Darwin’s Natural Pet Products Issues Voluntary Recalls for Darwin’s Brand Dog Foods Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia Coli O128 - FDA Safety Alerts & Drug Recalls

Darwin’s Natural Pet Products of Tukwila, Wash., a manufacturer of fresh raw meals for dogs, today announced it is voluntarily recalling a total of four lots of products after testing showed that some of the Chicken and Duck with Organic Vegetables Meals for Dogs may contain Salmonella, and the Turkey with Organic Vegetables Meals for Dogs sample may contain Salmonella and E. coli O128. These pathogens can cause serious and sometimes fatal infections.

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Allergy Alert Issued in Select Northern California Whole Foods Market Stores for Undeclared Egg in Some Cookies - FDA Safety Alerts & Drug Recalls

Nine Whole Foods Market stores in Northern California are voluntarily recalling some decorated (iced) cookies from the self-service cookie displays because the products contained egg allergen that was not listed on the product sign. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

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Correction to: Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria - Journal of Antibiotics

Correction to: Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria

Correction to: Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus <i>Halichondria</i>, Published online: 27 March 2018; doi:10.1038/s41429-017-0019-6

Correction to: Halistanol sulfates I and J, new SIRT1–3 inhibitory steroid sulfates from a marine sponge of the genus Halichondria

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Blue Ridge Beef Voluntarily Recalls BRB Complete Raw Pet Food Lot#GA0131 Because of Possible Contamination - FDA Safety Alerts & Drug Recalls

Blue Ridge Beef of Eatonton, GA, is voluntarily recalling lot#GA0131 of BRB Complete raw pet food because of the potential of contamination with Salmonella and Listeria monocytogenes. The cause of the recall: This recall was initiated after samples collected and tested by the FDA showed positive for Salmonella and Listeria monocytogenes. There has been no consumer or pet illnesses in association with this product. Blue Ridge Beef is voluntarily recalling this product lot as a commitment to consumer and pet health and safety.

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Mrs. Gerry’s Kitchen Issues Allergen Alert on Undeclared Seafood in Salad - FDA Safety Alerts & Drug Recalls

The salads may contain undeclared traces of imitation crab meat. People who have allergies to fish or shell fish run the risk of serious or life-threatening allergic reaction if they consume these products. The recalled salad was shipped to retail and food service distributers in IL, IA, KS, MI, MN, MT, NE, ND, SD, UT, and WI. No illnesses have been reported to date in connection with this problem.

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Kwik Trip, Inc. Issues Allergen Alert for Undeclared Fish or Shellfish on Premium Egg Salad Sandwich on Oat Multigrain Bread - FDA Safety Alerts & Drug Recalls

Kwik Trip, Inc. located in La Crosse, WI is issuing a voluntary recall of Kitchen’s Cravings Premium Egg Salad Sandwich on Oat Multigrain Bread because it may contain undeclared traces of imitation crab meat.

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Tamarack Inc. Recalls Eclipse Kratom Because of Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

Tamarack Inc. of Roy, Utah is voluntarily recalling Eclipse Kratom-containing powder products because it has the potential to be 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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Poppies International, Inc. Recalls Delizza Belgian Custard Cream Mini Eclairs 30 Count, Due to Potential Health Risks - FDA Safety Alerts & Drug Recalls

Poppies International, Inc. of Battleboro, NC is issuing a voluntary recall of selected products that were made during March 5-9, 2018 because they have the potential to be contaminated with Listeria monocytogenes, 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 fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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King Arthur Flour Company, Inc. Voluntarily Recalls Organic Coconut Flour (16 Oz.) Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

King Arthur Flour Company is voluntarily recalling a limited quantity (6,300 cases) of Organic Coconut Flour (16 oz.), after testing revealed the presence of Salmonella in 1 pouch of Organic Coconut Flour (16 oz.).

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Limited Production of Two Varieties of Milo’s Kitchen® Dog Treats Voluntarily Recalled Due to Potentially Elevated Levels of Thyroid Hormone - FDA Safety Alerts & Drug Recalls

The J.M. Smucker Company today announced a limited, voluntary recall of specific lots of two varieties of Milo’s Kitchen® dog treats, distributed nationally, because the products potentially contain elevated levels of beef thyroid hormone.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities

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BD Updates Instructions for Use for Certain BD Vacutainer® Blood Collection Tubes - FDA Safety Alerts & Drug Recalls

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it is updating the instructions for use of certain BD Vacutainer® tubes as part of its quality process to ensure that customers understand the appropriate uses of these products.

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Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues - FDA Press Releases

FDA on findings from ongoing investigation into lead testing issues; studies find chemical interaction during test processing may contribute to skewing results

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Cystargamide B, a cyclic lipodepsipeptide with protease inhibitory activity from Streptomyces sp. - Journal of Antibiotics

Cystargamide B, a cyclic lipodepsipeptide with protease inhibitory activity from Streptomyces sp.

Cystargamide B, a cyclic lipodepsipeptide with protease inhibitory activity from <i>Streptomyces</i> sp., Published online: 22 March 2018; doi:10.1038/s41429-018-0044-0

Cystargamide B, a cyclic lipodepsipeptide with protease inhibitory activity from Streptomyces sp.

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Tolyprolinol, a new dipeptide from Tolypocladium sp. FKI-7981 - Journal of Antibiotics

Tolyprolinol, a new dipeptide from Tolypocladium sp. FKI-7981

Tolyprolinol, a new dipeptide from <i>Tolypocladium</i> sp. FKI-7981, Published online: 22 March 2018; doi:10.1038/s41429-018-0041-3

Tolyprolinol, a new dipeptide from Tolypocladium sp. FKI-7981

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Weis Markets Issues an Allergy Alert For Weis Quality Store-Made Cole Slaw Sold in 8 Stores Due to Undeclared Egg Allergen - FDA Safety Alerts & Drug Recalls

Weis Markets today issued a recall for its store-made Weis Quality Cole Slaw (one pound container) for failing to list egg as an allergen on its label. This item was made in the seafood department.

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Piggie Park Enterprises Inc. Issues Allergy Alert on Undeclared Wheat and Soy in Maurice's Southern Gold Honey Sauce - FDA Safety Alerts & Drug Recalls

Piggie Park Enterprises Inc. is recalling Maurice’s Southern Gold Honey Sauce manufactured in the past two years (March 11, 2016 thru March 11, 2018), because it contains undeclared wheat and soy. People who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Piggie Park Enterprises Inc. Issues Allergy Alert on Undeclared Wheat and Soy in Gourmet Carolina Gold Honey Sauce - FDA Safety Alerts & Drug Recalls

Piggie Park Enterprises Inc. is recalling Gourmet Carolina Gold Honey Sauce manufactured in the past two years (March 11, 2016 thru March 11, 2018), because it contains undeclared wheat and soy. People who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Radagast Pet Food, Inc. Voluntarily Recalls One Lot of Rad Cat Raw Diet Free-Range Chicken and One Lot of Free-Range Turkey Recipe Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Radagast Pet Food, Inc. of Portland, OR is recalling one lot of Free-Range Chicken and one lot of Free-Range Turkey Recipe because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

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FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy - FDA Press Releases

FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy

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Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products - FDA Press Releases

FDA takes steps to reduce tobacco use, especially among youth, by exploring options to address the role of flavors ‒ including menthol ‒ in tobacco products.

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Vietti Foods Issues Allergy Alert on Undeclared Wheat and Eggs in Southgate Hot Dog Chili Sauce - FDA Safety Alerts & Drug Recalls

Vietti Foods is recalling approximately 200 cases of 15 oz cans of Southgate Hot Dog Chili Sauce, UPC 0 71846 95242 6, LOT # P642 M1217 70026. This recall has been initiated due to mislabeling because some of the cans may contain Dumplings with Chicken instead of Hot Dog Chili Sauce.

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Twelve Haggen Stores Voluntarily Recall Select Deli Products in Cooperation with Taylor Farms’ Onion Recall Due to Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

In cooperation with the Taylor Farms recall of diced yellow onions that may be contaminated with Salmonella, 12 Haggen stores are voluntarily recalling deli products that contain raw Taylor Farms brand diced yellow onions.

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Natural Grocers Issues Recall on Coconut Smiles Organic Due to Salmonella - FDA Safety Alerts & Drug Recalls

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 10-ounce Coconut Smiles Organic due to the potential to be 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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Confirmation of the absolute configuration of Stachybotrin C using single-crystal X-ray diffraction analysis of its 4-bromobenzyl ether derivative - Journal of Antibiotics

Confirmation of the absolute configuration of Stachybotrin C using single-crystal X-ray diffraction analysis of its 4-bromobenzyl ether derivative

Confirmation of the absolute configuration of Stachybotrin C using single-crystal X-ray diffraction analysis of its 4-bromobenzyl ether derivative, Published online: 19 March 2018; doi:10.1038/s41429-018-0042-2

Confirmation of the absolute configuration of Stachybotrin C using single-crystal X-ray diffraction analysis of its 4-bromobenzyl ether derivative

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Oregon Food Bank Voluntarily Recalls Nutritional Yeast - FDA Safety Alerts & Drug Recalls

Oregon Food Bank is voluntarily recalling 1,219 pounds of nutritional yeast, which was donated to the food bank. No illness has been reported but it was donated at the same time as two other recalled products -- chia and pumpkin seeds.

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Oregon Food Bank Voluntarily Recalls Pumpkin Seeds Because Of Possible Contamination By Listeria Species - FDA Safety Alerts & Drug Recalls

As a result of the ongoing recall of donated chia seeds that began on March 12, 2018, Oregon Food Bank has initiated a voluntary recall of 63,825 pounds of pumpkin seeds received on the same donation. These donated pumpkin seeds have the potential to be contaminated with Listeria species.

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International Harvest, Inc. Recalls Organic Go Smile! Raw Coconut Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

International Harvest, Inc of Mount Vernon, NY is recalling 14,620 lbs. of bulk and 24,270 bags of Organic Go Smile! Raw Coconut, because it has the potential to be 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

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PDX Aromatics Expands Recall of Kratom Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

PDX Aromatics, DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, is expanding the scope of their 3/9/2018 voluntary recall of certain kratom white vein powder and capsule products and red vein powder products because they have the potential to be contaminated with Salmonella. The expanded recall is being initiated in response to additional positive findings of Salmonella associated with Aromatics' products following the FDA initial investigation.

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River Valley Sprouts Recalls Alfalfa Sprouts and Garlic Alfalfa Sprouts Due to Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

River Valley Sprouts is voluntarily recalling its 5 ounce Alfalfa Sprouts, 4 ounce Alfalfa Sprouts, 5 ounce Garlic/Alfalfa and 5 ounce Variety sprouts because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail, elderly people, and others with weakened immune systems. Healthy persons often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illness such as arterial infections, endocarditis and arthritis.

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Chris’s Cookies Recalls Chocolate Chip Cookies Due to Undeclared Peanuts - FDA Safety Alerts & Drug Recalls

Teterboro, NJ (March 15, 2018) - Chris’s Cookies has recalled one lot of its Trader Joe’s Chocolate Chip Cookie 12 Oz (340g) Bags (Barcode#: 0068 0752) after a report that Peanut Butter Chocolate Chip Cookies were discovered in a Chocolate Chip Cookie Bag, and therefore the product may contain undeclared peanuts. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they eat this product.

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Bayer Issues Voluntary Recall of Alka-Seltzer Plus® Products - FDA Safety Alerts & Drug Recalls

Bayer is voluntarily recalling Alka-Seltzer Plus® packages that: • Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018. • Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall (please see attached photos). The affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels - FDA Press Releases

FDA takes pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.

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Prognosis After Emergency Department Intubation to Inform Shared Decision-Making - American Geriatric Society

Objectives

To inform the shared decision-making process between clinicians and older adults and their surrogates regarding emergency intubation.

Design

Retrospective cohort study.

Setting

Multicenter, emergency department (ED)-based cohort.

Participants

Adults aged 65 and older intubated in the ED from 2008 to 2015 from 262 hospitals across the United States (>95% of U.S. nonprofit academic medical centers).

Measurements

Our primary outcome was age-specific in-hospital mortality. Secondary outcomes were age-specific odds of death after adjusting for race, comorbid conditions, admission diagnosis, hospital disposition, and geographic region.

Results

We identified 41,463 ED intubation encounters and included 35,036 in the final analysis. Sixty-four percent were in non-Hispanic whites and 54% in women. Overall in-hospital mortality was 33% (95% confidence interval (CI)=34–35%). Twenty-four percent (95% CI=24–25%) of subjects were discharged to home, and 41% (95% CI=40–42%) were discharged to a location other than home. Mortality was 29% (95% CI=28–29%) for individuals aged 65 to 74, 34% (95% CI=33–35%) for those aged 75 to 79, 40% (95% CI=39–41%) for those aged 80 to 84, 43% (95% CI=41–44%) for those aged 85 to 89, and 50% (95% CI=48–51%) for those aged 90 and older.

Conclusion

After emergency intubation, 33% percent of older adults die during the index hospitalization. Only 24% of survivors are discharged to home. Simple, graphic representations of this information, in combination with an experienced clinician's overall clinical assessment, will support shared decision-making regarding unplanned intubation.

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Improving Care Using a Bidirectional Geriatric Cardiology Consultative Conference - American Geriatric Society

More than 13 million persons in the United States aged 65 and older have cardiovascular disease (CVD), and this population is expected to increase exponentially over the next several decades. In the absence of clinical studies that would inform how best to manage this population, there is an urgent need for collaborative, thoughtful approaches to their care. Although cardiologists are traditionally regarded as leaders in the care of older adults with CVD, these individuals have multiple comorbidities, physiological differences, and distinct goals of care than younger patients that require a specialized geriatric lens. Thus, collaboration is needed between geriatricians, cardiologists, and other specialists to address the unique needs of this growing population. Accordingly, clinicians at New York University Langone Health and School of Medicine established a monthly Geriatric Cardiology Conference to foster an integrative approach to the care of older adults with CVD by uniting specialists across disciplines to collaborate on treatment strategies. At each conference, an active case is discussed and analyzed in detail, and a consensus is reached among participants regarding optimal treatment strategies. The conference attracts faculty and trainees at multiple levels from geriatrics, cardiology, and cardiothoracic surgery. The model may serve as a paradigm for other institutions moving towards geriatric-informed care of older adults with CVD.

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Association Between Neighborhood Cohesion and Self-Neglect: Exploring Mental Health in Asian Americans - American Geriatric Society

See the Reply by Hei et al.

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Reply to: Association between Neighborhood Cohesion and Self-Neglect: Exploring Mental Health in Asian Americans - American Geriatric Society

This letter comments on the letter by Lee et al.

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Spiciferone analogs from an endophytic fungus Phoma betae collected from desert plants in West China - Journal of Antibiotics

Spiciferone analogs from an endophytic fungus Phoma betae collected from desert plants in West China

Spiciferone analogs from an endophytic fungus <i>Phoma betae</i> collected from desert plants in West China, Published online: 14 March 2018; doi:10.1038/s41429-018-0037-z

Spiciferone analogs from an endophytic fungus Phoma betae collected from desert plants in West China

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Umezawamides, new bioactive polycyclic tetramate macrolactams isolated from a combined-culture of Umezawaea sp. and mycolic acid-containing bacterium - Journal of Antibiotics

Umezawamides, new bioactive polycyclic tetramate macrolactams isolated from a combined-culture of Umezawaea sp. and mycolic acid-containing bacterium

Umezawamides, new bioactive polycyclic tetramate macrolactams isolated from a combined-culture of <i>Umezawaea</i> sp. and mycolic acid-containing bacterium, Published online: 14 March 2018; doi:10.1038/s41429-018-0040-4

Umezawamides, new bioactive polycyclic tetramate macrolactams isolated from a combined-culture of Umezawaea sp. and mycolic acid-containing bacterium

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Health-Related Quality of Life in a Predictive Model for Mortality in Older Breast Cancer Survivors - American Geriatric Society

Objectives

To develop a predictive model and risk score for 10-year mortality using health-related quality of life (HRQOL) in a cohort of older women with early-stage breast cancer.

Design

Prospective cohort.

Setting

Community.

Participants

U.S. women aged 65 and older diagnosed with Stage I to IIIA primary breast cancer (N=660).

Measurements

We used medical variables (age, comorbidity), HRQOL measures (10-item Physical Function Index and 5-item Mental Health Index from the Medical Outcomes Study (MOS) 36-item Short-Form Survey; 8-item Modified MOS Social Support Survey), and breast cancer variables (stage, surgery, chemotherapy, endocrine therapy) to develop a 10-year mortality risk score using penalized logistic regression models. We assessed model discriminative performance using the area under the receiver operating characteristic curve (AUC), calibration performance using the Hosmer-Lemeshow test, and overall model performance using Nagelkerke R² (NR).

Results

Compared to a model including only age, comorbidity, and cancer stage and treatment variables, adding HRQOL variables improved discrimination (AUC 0.742 from 0.715) and overall performance (NR 0.221 from 0.190) with good calibration (p=0.96 from HL test).

Conclusion

In a cohort of older women with early-stage breast cancer, HRQOL measures predict 10-year mortality independently of traditional breast cancer prognostic variables. These findings suggest that interventions aimed at improving physical function, mental health, and social support might improve both HRQOL and survival.

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Schwartz Brothers Bakery Issues Allergy Alert on Undeclared Egg in Gourmet Cream Cheese Cinnamon Rolls - FDA Safety Alerts & Drug Recalls

Schwartz Brothers Bakery of Seattle, WA is recalling 106 units of Gourmet Cream Cheese Cinnamon Rolls because it may contain undeclared Egg. People who have an allergy or severe sensitivity to Egg run the risk of serious or life-threatening allergic reaction if they consume these products.

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Wegmans Food Markets Issues Allergen Alert on Undeclared Egg in Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. Sold in the Sushi Department - FDA Safety Alerts & Drug Recalls

Wegmans Food Markets, Inc. is recalling Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC7-66630-98023) with a best-by of 7/4/18 or 7/5/18 because the product may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.

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Consumer Alert: Listeria Contamination In Maiden’s Creamery Wild Meadow Raw Goat Milk Cheese - FDA Safety Alerts & Drug Recalls

New York State Agriculture Commissioner Richard Ball today warned consumers not to consume The Maiden’s Creamery “Wild Meadow” Raw Goat Milk Cheese made by Mark Harvey, 1277 Copes Corner Road, South New Berlin, NY 13843 due to possible Listeria contamination. To date, no illnesses have been reported to the Department in connection with this product.

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Expanding Home-Based Primary Care to American Indian Reservations and Other Rural Communities: An Observational Study - American Geriatric Society

Background/Objectives

Home-based primary care (HBPC) is a comprehensive, interdisciplinary program to meet the medical needs of community-dwelling populations needing long-term care (LTC). The U.S. Department of Veterans Affairs (VA) expanded its HBPC program to underserved rural communities, including American Indian reservations, providing a “natural laboratory” to study change in access to VA LTC benefits and utilization outcomes for rural populations that typically face challenges in accessing LTC medical support.

Design

Pretest-Posttest quasi-experimental approach with interrupted time-series design using linked VA, Medicare, and Indian Health Service (IHS) records.

Setting

American Indian reservations and non-Indian communities in rural HBPC catchment areas.

Participants

376 veterans (88 IHS beneficiaries, 288 non-IHS beneficiaries) with a HBPC length of stay of 12 months or longer.

Measurements

Baseline demographic and health characteristics, activities of daily living (ADL), previous VA enrollment, and hospital admissions and emergency department (ED) visits as a function of time, accounting for IHS beneficiary and functional statuses.

Results

For HBPC users, VA enrollment increased by 22%. At baseline, 30% of IHS and non-IHS beneficiaries had 2 or more ADLs impairments; IHS populations were younger (P < .001) and had more diagnosed chronic diseases (P = .007). Overall, hospital admissions decreased by 0.10 (95% confidence interval (CI) = −0.14 to −0.05) and ED visits decreased by 0.13 (95% CI = −0.19 to −0.07) in the 90 days after HBPC admission (Ps < .001) and these decreases were maintained over 1 year follow-up. Before HBPC, probability of hospital admission was 12% lower for IHS than non-IHS beneficiaries (P = .02).

Conclusion

Introducing HBPC to rural areas increased access to LTC and enrollment for healthcare benefits, with equitable outcomes in IHS and non-IHS populations.

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Effects of Caps on Cost Sharing for Skilled Nursing Facility Services in Medicare Advantage Plans - American Geriatric Society

Objectives

To evaluate a federal regulation effective in 2011 that limited how much that Medicare Advantage (MA) plans could charge for the first 20 days of care in a skilled nursing facility (SNF).

Design

Difference-in-differences retrospective analysis comparing SNF utilization trends from 2008–2012.

Setting

Select MA plans.

Participants

Members of 27 plans with mandatory cost sharing reductions (n=132,000) and members of 21 plans without such reductions (n=138,846).

Measurements

Mean monthly number of SNF admissions and days per 1,000 members; annual proportion of MA enrollees exiting the plan.

Results

In plans with mandated cost sharing reductions, cost sharing for the first 20 days of SNF care decreased from an average of $2,039 in 2010 to $992 in 2011. In adjusted analyses, plans with mandated cost-sharing reductions averaged 158.1 SNF days (95% confidence interval (CI)=153.2–163.1 days) per 1,000 members per month before the cost sharing cap. This measure increased by 14.3 days (95% CI=3.8–24.8 days, p=0.009) in the 2 years after cap implementation. However, increases in SNF utilization did not significantly differ between plans with and without mandated cost-sharing reductions (adjusted between-group difference: 7.1 days per 1,000 members, 95% CI=–6.5–20.8, p=.30). Disenrollment patterns did not change after the cap took effect.

Conclusions

When a federal regulation designed to protect MA members from high out-of-pocket costs for postacute care took effect, the use of SNF services did not change.

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Policies Regarding Sexual Expression in Spanish Long-Term Care Facilities for Older People - American Geriatric Society

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Midwest Northern Nut Issues Voluntary Allergy Alert On Various Undeclared Allergens In Their Nut And Seed Snack Products - FDA Safety Alerts & Drug Recalls

Midwest Northern Nut of Minneapolis, MN, is voluntarily recalling various products roasted in their facility and sold in consumer packaging that may contain undeclared peanuts and various tree nuts (listed below).

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PDX Aromatics Recalls Kratom Powder Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

PDX Aromatics of Portland, Oregon DBA Kraken Kratom, Phytoextractum, and Soul Speciosa, has initiated a recall of certain kratom-containing powder products because it has the potential to be 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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Starwest Botanicals Inc. Product Recalls Organic Cardamom Pods Green (Whole) Due to Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

Starwest Botanicals is voluntarily recalling Starwest Botanicals Organic Cardamom Pods Green (Whole), which is packaged in Mylar 1 pound bags and in bulk packs.

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FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk - FDA Press Releases

FDA has issued warning letters to Olympus, FujiFilm and Pentax, for failing to comply with section 522 orders on postmarket surveillance studies for duodenoscopes

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Diabetes, Heart Disease, and Dementia: National Estimates of Functional Disability Trajectories - American Geriatric Society

Objectives

To estimate the associations between diabetes, heart disease, and dementia, which may increase the difficulty of self-care; model functional disability trajectories jointly with attrition (death or dropout) over 5 years.

Design

Population-based complex survey design.

Setting

National Health and Aging Trends Study.

Participants

Community-dwelling Medicare beneficiaries aged 65 and older (N=7,609).

Measurements

National estimates were generated using sampling weights. Sociodemographic characteristics, self-reported physician-diagnosed chronic conditions, six activities of daily living (ADL), and cognitive status were ascertained in annual in-person interviews. A joint model using group-based trajectory modeling was used to estimate the number of ADL disabilities and attrition probability. Multinomial logistic regression with survey weights was used to estimate the association between diabetes, heart disease, and dementia and resultant trajectories of disability, with the least disabled trajectory used as a reference.

Results

Three functional disability trajectories were identified: 26.9 million (76.3%) individuals with no disability and a constant study attrition of 14.3%, 4.9 million (13.9%) with mild and increasing disability and 12% attrition in 2012 and 27.2% in 2015, and 3.4 million (9.7%) with severe and increasing disability and 25.4% attrition in 2012 and 35% in 2015. Persons with possible dementia, possible dementia and diabetes, or possible dementia with diabetes and heart disease had significantly greater odds of being on the mild disability trajectory than those with no disability. Persons with probable dementia, representing more than 1.5 million persons, regardless of concurrent conditions, had significantly greater odds of being on the severe disability trajectory than on the no disability trajectory.

Conclusions

Methods that generate national estimates and account for attrition and for multiple chronic conditions and cognitive status may be useful for health policy-makers to make decisions on care provisions and services.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.” - FDA Press Releases

Commissioner remarks as prepared for testimony at the hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.”

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Statement from FDA Commissioner Scott Gottlieb, M.D., on effort to help bolster U.S. shellfish market by taking mutually beneficial steps to resume shellfish trade with the EU - FDA Press Releases

FDA announces proposed shellfish equivalence determination with the EU that will create new market access for U.S. exporters as well as make a wider selection of healthy and safe shellfish options available to consumers. It will also assure American consumers that imported molluscan shellfish from Europe is as safe as what we produce in the U.S.

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Redbarn Pet Products Expands Voluntary Recall of Dog Chews - FDA Safety Alerts & Drug Recalls

Redbarn Pet Products, LLC of Long Beach, CA is expanding their voluntarily recall initially issued on February 9th. The recall expanded to include all lots of product manufactured with raw material from a single supplier because it has the potential to be contaminated with Salmonella. The recall is limited to products distributed March 2017 through February 2018. This supplier’s raw material was used to produce the Redbarn, Chewy Louie, Dentley’s and Good Lovin’ brand products listed below with best-buy dates ending in BC. In total, 24 SKUs are affected.

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Ciolo Foods Issues Allergy Alert for Undeclared Tree Nuts in “Ciolo Nut-Free Basil - FDA Safety Alerts & Drug Recalls

Ciolo Foods of Lafayette, CO has voluntarily recalled it’s 7-ounce containers of “Nut-Free Basil Pesto” because they contain undeclared tree nuts (Pine Nuts and Walnuts). People who have allergies or severe sensitivity to Pine Nuts and/or Walnuts run the risk of serious allergic reaction if they consume this product.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA’s commitment to keep women informed - FDA Press Releases

The FDA is actively evaluating a significant increase in the number of medical device reports submitted to the agency on the Essure device from October to December 2017

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Streptosporangium minutum sp. nov., isolated from garden soil exposed to microwave radiation - Journal of Antibiotics

Streptosporangium minutum sp. nov., isolated from garden soil exposed to microwave radiation

<i>Streptosporangium minutum</i> sp. nov., isolated from garden soil exposed to microwave radiation, Published online: 07 March 2018; doi:10.1038/s41429-018-0036-0

Streptosporangium minutum sp. nov., isolated from garden soil exposed to microwave radiation

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Structure and biosynthesis of mayamycin B, a new polyketide with antibacterial activity from Streptomyces sp. 120454 - Journal of Antibiotics

Structure and biosynthesis of mayamycin B, a new polyketide with antibacterial activity from Streptomyces sp. 120454

Structure and biosynthesis of mayamycin B, a new polyketide with antibacterial activity from <i>Streptomyces</i> sp. 120454, Published online: 07 March 2018; doi:10.1038/s41429-018-0039-x

Structure and biosynthesis of mayamycin B, a new polyketide with antibacterial activity from Streptomyces sp. 120454

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Computational study on formation of 15-membered azalactone by double reductive amination using molecular mechanics and density functional theory calculations - Journal of Antibiotics

Computational study on formation of 15-membered azalactone by double reductive amination using molecular mechanics and density functional theory calculations

Computational study on formation of 15-membered azalactone by double reductive amination using molecular mechanics and density functional theory calculations, Published online: 07 March 2018; doi:10.1038/s41429-018-0030-6

Computational study on formation of 15-membered azalactone by double reductive amination using molecular mechanics and density functional theory calculations

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Pyrizomicin A and B: structure and bioactivity of new thiazolyl pyridines from Lechevalieria aerocolonigenes K10-0216 - Journal of Antibiotics

Pyrizomicin A and B: structure and bioactivity of new thiazolyl pyridines from Lechevalieria aerocolonigenes K10-0216

Pyrizomicin A and B: structure and bioactivity of new thiazolyl pyridines from <i>Lechevalieria aerocolonigenes</i> K10-0216, Published online: 07 March 2018; doi:10.1038/s41429-018-0038-y

Pyrizomicin A and B: structure and bioactivity of new thiazolyl pyridines from Lechevalieria aerocolonigenes K10-0216

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Barriers to Implementation of Geriatric Medicine Programs: When Advocacy Meets Reality - American Geriatric Society

This editorial comments on the article by Boustani et al.

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Agile Implementation: A Blueprint for Implementing Evidence-Based Healthcare Solutions - American Geriatric Society

Objectives

To describe the essential components of an Agile Implementation (AI) process, which rapidly and effectively implements evidence-based healthcare solutions, and present a case study demonstrating its utility.

Design

Case demonstration study.

Setting

Integrated, safety net healthcare delivery system in Indianapolis.

Participants

Interdisciplinary team of clinicians and administrators.

Measurements

Reduction in dementia symptoms and caregiver burden; inpatient and outpatient care expenditures.

Results

Implementation scientists were able to implement a collaborative care model for dementia care and sustain it for more than 9 years. The model was implemented and sustained by using the elements of the AI process: proactive surveillance and confirmation of clinical opportunities, selection of the right evidence-based healthcare solution, localization (i.e., tailoring to the local environment) of the selected solution, development of an evaluation plan and performance feedback loop, development of a minimally standardized operation manual, and updating such manual annually.

Conclusion

The AI process provides an effective model to implement and sustain evidence-based healthcare solutions.

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Weis Markets Expands Allergy Alert for Weis Quality Dried Beef Party Rye Dip Sold in 11 Stores Due to Undeclared Milk and Egg Allergen - FDA Safety Alerts & Drug Recalls

Weis Markets today announced it has expanded its recall for its store-made Weis Quality Dried Beef Party Rye dip for failing to list egg and milk allergens on its label. Food allergies are an immune system reaction that occurs soon after eating a food containing an allergen.

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FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply - FDA Press Releases

FDA approves first tests to screen for tickborne parasite in blood donations

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Raw Basics, LLC. Recalls Tucker’s 5lb Pork-Bison Box Because of Possible Salmonella Health Risk - FDA Safety Alerts & Drug Recalls

Raw Basics, LLC. of Pleasant Prairie, WI is recalling 540lb of 5lb Pork-Bison Boxes because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

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FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world - FDA Press Releases

FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

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FDA approves new HIV treatment for patients who have limited treatment options - FDA Press Releases

The FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies.

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Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results - FDA Safety Alerts & Drug Recalls

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals.

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FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes - FDA Press Releases

FDA has authorized 23andMe to market a consumer test that reports only 3 out of more than 1,000 known mutations in BRCA genes

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Medicare Part D Use of Older Medicare Beneficiaries Admitted to Hospice - American Geriatric Society

Objectives

To describe medications that older hospice beneficiaries receive through Medicare Part D and assess patterns in Part D use for individuals admitted to hospice for cancer and noncancer causes.

Design

Descriptive cohort analysis using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database.

Setting

U.S. hospice programs

Participants

Part D-enrolled Medicare beneficiaries aged 66 and older who were admitted to hospice and died while under hospice care between January 1, 2008, and December 31, 2013 (N = 88,957).

Measurements

We determined the 25 most commonly dispensed medications and the prevalence of at least 1 dispensing through Part D after hospice admission. The prevalence and temporal trends in receipt of opioid analgesics and several preventative medication classes are described.

Results

More than half of individuals admitted to hospice for cancer (53.5%) and noncancer causes (52.9%) received at least 1 medication through Part D after hospice admission. The prevalence of receiving at least 1 Part D medication after admission was greatest in individuals admitted for debility or failure to thrive (63.5%) and dementia (61.5%) and lowest in those admitted for ischemic stroke (35.4%) and renal disease (36.0%). Beta-blockers, angiotensin-converting enzyme inhibitors, proton pump inhibitors, and statins were among the most common preventative drug classes received overall, although prevalence differed according to admission diagnosis. Nearly 1 in 6 individuals received opioids through Part D after admission, with prevalence steadily decreasing over the study period.

Conclusion

Receipt of medications through Medicare Part D after hospice admission is common, particularly for preventative medications, and varies according to admission diagnosis. Further research aimed at better understanding individual-, provider-, and healthcare system–level contributors to nonpalliative medication use in the hospice population is warranted.

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A Multivariable Prediction Model for Mortality in Individuals Admitted for Heart Failure - American Geriatric Society

Objectives

To derive and validate a 30-day mortality clinical prediction rule for heart failure based on admission data and prior healthcare usage. A secondary objective was to determine the discriminatory function for mortality at 1 and 2 years.

Design

Observational cohort.

Setting

Veterans Affairs inpatient medical centers (n=124).

Participants

The derivation (2010–12; n=36,021) and validation (2013–15; n=30,364) cohorts included randomly selected veterans admitted for HF exacerbation (mean age 71±11; 98% male).

Measurements

The primary outcome was 30-day mortality. Secondary outcomes were 1- and 2-year mortality. Candidate variables were drawn from electronic medical records. Discriminatory function was measured as the area under the receiver operating characteristic curve.

Results

Thirteen risk factors were identified: age, ejection fraction, mean arterial pressure, pulse, brain natriuretic peptide, blood urea nitrogen, sodium, potassium, more than 7 inpatient days in the past year, metastatic disease, and prior palliative care. The model stratified participants into low- (1%), intermediate- (2%), high- (5%), and very high- (15%) mortality risk groups (C-statistic=0.72, 95% confidence interval (CI)=0.71–0.74). These findings were confirmed in the validation cohort (C-statistic=0.70, 95% CI=0.68–0.71). Subgroup analysis of age strata confirmed model discrimination.

Conclusion

This simple prediction rule allows clinicians to risk-stratify individuals on admission for HF using characteristics captured in electronic medical record systems. The identification of high-risk groups allows individuals to be targeted for discussion of goals and treatment.

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Using the Hendrich II Inpatient Fall Risk Screen to Predict Outpatient Falls After Emergency Department Visits - American Geriatric Society

Objectives

To evaluate the utility of routinely collected Hendrich II fall scores in predicting returns to the emergency department (ED) for falls within 6 months.

Design

Retrospective electronic record review.

Setting

Academic medical center ED.

Participants

Individuals aged 65 and older seen in the ED from January 1, 2013, through September 30, 2015.

Measurements

We evaluated the utility of routinely collected Hendrich II fall risk scores in predicting ED visits for a fall within 6 months of an all-cause index ED visit.

Results

For in-network patient visits resulting in discharge with a completed Hendrich II score (N = 4,366), the return rate for a fall within 6 months was 8.3%. When applying the score alone to predict revisit for falls among the study population the resultant receiver operating characteristic (ROC) plot had an area under the curve (AUC) of 0.64. In a univariate model, the odds of returning to the ED for a fall in 6 months were 1.23 times as high for every 1-point increase in Hendrich II score (odds ratio (OR)=1.23 (95% confidence interval (CI)=1.19–1.28). When included in a model with other potential confounders or predictors of falls, the Hendrich II score is a significant predictor of a return ED visit for fall (adjusted OR=1.15, 95% CI=1.10–1.20, AUC=0.75).

Conclusion

Routinely collected Hendrich II scores were correlated with outpatient falls, but it is likely that they would have little utility as a stand-alone fall risk screen. When combined with easily extractable covariates, the screen performs much better. These results highlight the potential for secondary use of electronic health record data for risk stratification of individuals in the ED. Using data already routinely collected, individuals at high risk of falls after discharge could be identified for referral without requiring additional screening resources.

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IDLife, LLC Issues Allergy Alert on Various Undeclared Allergens in its Bars - FDA Safety Alerts & Drug Recalls

IDLife, LLC of Frisco, TX is voluntarily recalling its line of Protein Bars (Lot #s PR33471, PR31771, & PR31971), Snack Bars (Lot #s SN32071 & SN30771), and Kids Bars (Lot #s A3617-1 & 03047-1), because they may contain undeclared allergens. As part of its quality control review process, IDLife discovered that the lots of Protein Bars referenced above may contain undisclosed almonds, the lots of Snack Bars referenced above may contain undisclosed peanuts, and the lots of Kids Bars may contain undisclosed almonds and coconut oil.

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Kodiak Cakes Issues Allergy Alert on Undeclared Milk in Kodiak Cakes Blueberry Chia Energy Waffles 10.72 oz. Product UPC code is 7 05599 01215 0. - FDA Safety Alerts & Drug Recalls

Kodiak Cakes of Park City, UT is recalling all lots and codes of Kodiak Cakes Blueberry Chia Energy Waffles 10.72 oz that were on shelf prior to March 5, 2018 because they contain undeclared milk. 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.

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Hospira Issues a Voluntary Nationwide Recall for Hydromorphone HCL Injection, USP CII Due to The Potential for Empty or Cracked Glass Vials - FDA Safety Alerts & Drug Recalls

Hospira, Inc., a Pfizer company, is voluntarily recalling three lots of Hydromorphone HCl Injection, USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital/institution level. Hospira, Inc. initiated this recall on February 07, 2018 due to the potential that units from these lots may be empty or cracked at the bottom of the glass vial.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s commitment to modernizing food and nutrition programs - FDA Press Releases

FDA announces commitment to modernize and streamline our food and nutrition programs to make sure that our investments of new and existing resources achieve their intended public health goals.

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Steve’s Real Food Voluntarily Recalls Raw Frozen Dog Food Turkey Canine Recipe Due to Possible Salmonella Contamination - FDA Safety Alerts & Drug Recalls

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Raw Frozen Dog Food Turkey Canine Recipe due to their potential to be contaminated with Salmonella.

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Predicting Potential Adverse Events During a Skilled Nursing Facility Stay: A Skilled Nursing Facility Prognosis Score - American Geriatric Society

Objectives

To derive a risk prediction score for potential adverse outcomes in older adults transitioning to a skilled nursing facility (SNF) from the hospital.

Design

Retrospective analysis.

Setting

Medicare Current Beneficiary Survey (2003–11).

Participants

Previously community-dwelling Medicare beneficiaries who were hospitalized and discharged to SNF for postacute care (N=2,043).

Measurements

Risk factors included demographic characteristics, comorbidities, health status, hospital length of stay, prior SNF stays, SNF size and ownership, treatments received, physical function, and active signs or symptoms at time of SNF admission. The primary outcome was a composite of undesirable outcomes from the patient perspective, including hospital readmission during the SNF stay, long SNF stay (≥100 days), and death during the SNF stay.

Results

Of the 2,043 previously community-dwelling beneficiaries hospitalized and discharged to a SNF for post-acute care, 589 (28.8%) experienced one of the three outcomes, with readmission (19.4%) most common, followed by mortality (10.5%) and long SNF stay (3.5%). A risk score including 5 factors (Barthel Index, Charlson-Deyo comorbidity score, hospital length of stay, heart failure diagnosis, presence of an indwelling catheter) demonstrated very good discrimination (C-statistic=0.75), accuracy (Brier score=0.17), and calibration for observed and expected events.

Conclusion

Older adults frequently experience potentially adverse outcomes in transitions to a SNF from the hospital; this novel score could be used to better match resources with patient risk.

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Minimum Data Set Changes in Health, End-Stage Disease and Symptoms and Signs Scale: A Revised Measure to Predict Mortality in Nursing Home Residents - American Geriatric Society

Objectives

To revise the Minimum Data Set (MDS) Changes in Health, End-stage disease and Symptoms and Signs (CHESS) scale, an MDS 2.0-based measure widely used to predict mortality in institutional settings, in response to the release of MDS 3.0.

Design

Development of a predictive scale using observational data from the MDS and Medicare Master Beneficiary Summary File.

Setting

All Centers for Medicare and Medicaid Services (CMS)-certified nursing homes in the United States.

Participants

Development cohort of 1.3 million Medicare beneficiaries newly admitted to a CMS-certified nursing home during 2012. Primary validation cohort of 1.2 million Medicare recipients who were newly admitted to a CMS-certified nursing home during 2013.

Measurements

Items from the MDS 3.0 assessments identified as likely to predict mortality. Death information was obtained from the Medicare Master Beneficiary Summary File.

Results

MDS-CHESS 3.0 scores ranges from 0 (most stable) to 5 (least stable). Ninety-two percent of the primary validation sample with a CHESS scale score of 5 and 15% with a CHESS scale of 0 died within 1 year. The risk of dying was 1.63 times as great (95% CI=1.628–1.638) for each unit increase in CHESS scale score. The MDS-CHESS 3.0 is also strongly related to hospitalization within 30 days and successful discharge to the community. The scale predicted death in long-stay residents at 30 days (C=0.759, 95% confidence interval (CI)=0.756–0.761), 60 days (C=0.716, 95% CI=0.714–0.718) and 1 year (C=0.655, 95% CI=0.654–0.657).

Conclusion

The MDS-CHESS 3.0 predicts mortality in newly admitted and long-stay nursing home populations. The additional relationship to hospitalizations and successful discharges to community increases the utility of this scale as a potential risk adjustment tool.

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Rational Suicide in Elderly Adults: A Clinician's Perspective - American Geriatric Society

Geriatricians are increasingly encountering older adults expressing suicidal wishes in the absence of overt mental illness. This is expected to grow as life expectancy increases. This article describes the case of an older adult who expressed the wish to end his life in the absence of a diagnosable mental illness. Although he had chronic medical illnesses, he was not terminally ill. The complex subject of rational suicide in elderly adults is approached from a clinician's perspective. Issues of ageism, gerontophobia, and changing perspectives on death are highlighted. The experience of being a Baby Boomer and its influence on rational suicide is reviewed. Finally, clinical topics such as aging, frailty, dependence on younger and healthier individuals, and the older adult's need for a sense of control are explored.

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Social Causes of Rational Suicide in Older Adults - American Geriatric Society

This editorial comments on the article by Meera Balasubramaniam.

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Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity: Measure Development for the Quality Payment Program - CMS Blog

CMS Blog

https://blog.cms.gov/2018/03/02/medicare-access-and-chip-reauthorization-act-of-2015-macra-funding-opportunity

March 2, 2018
By Kate Goodrich, MD
Director, CMS Center for Clinical Standards and Quality & CMS Chief Medical Officer

 

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity:Measure Development for the Quality Payment Program

CMS is pleased to announce a new funding opportunity for the development, improvement, updating, and expansion of quality measures for use in the Quality Payment Program. CMS will be partnering directly with clinicians, patients, and other stakeholders to provide up to $30 million of funding and technical assistance in development of quality measures over three years.

Cooperative agreements provide a unique opportunity for CMS to partner with external entities, such as clinical specialty societies, clinical professional organizations, patient advocacy organizations, educational institutions, independent research organizations, and health systems, in developing, improving, updating, and expanding quality measures for the Quality Payment Program. By giving external entities needed resources to help guide their measure-development efforts though this funding opportunity, CMS can leverage the unique perspectives and expertise of these external entities, such as clinician and patient perspectives, to advance the Quality Payment Program measure portfolio. The cooperative agreements will allow CMS to collaborate with stakeholders to address essential topics such as: clinician engagement, burden minimization, consumer-informed decisions, critical measure gaps, quality measure alignment, consumer-informed decisions, clinician engagement, and efficient data collection that minimizes health care provider burden.

The priority measures developed, improved, updated or expanded under the cooperative agreements will be aligned with the CMS Quality Measure Development Plan. The CMS Quality Measure Development Plan provides a strategy for filling clinician and specialty area measure gaps and for recommendations to close these gaps in order to support the Quality Payment Program, and identifies the following initial priority areas for measure development: Clinical Care, Safety, Care Coordination, Patient and Caregiver Experience, Population Health and Prevention, and Affordable Care. The gap areas include, but not limited to: Orthopedic Surgery, Pathology, Radiology, Mental Health and substance use conditions, Oncology, Palliative Care, and Emergency Medicine.

More broadly than the CMS Quality Measure Development Plan, which is specific for the Quality Payment Program, CMS measures work is guided by the Meaningful Measurement framework which identifies the highest priorities for quality measurement and improvement. The Meaningful Measure Areas serve as the connectors between CMS goals under development and individual measures/initiatives that demonstrate how high quality outcomes for our Medicare, Medicaid, and CHIP beneficiaries are being achieved. They are concrete quality topics which reflect core issues that are most vital to high quality care and better patient outcomes.

Through these cooperative agreements, CMS aims to provide the necessary support to help external entities expand the Quality Payment Program quality measure portfolio with a focus on clinical and patient perspectives and minimizing burden for clinicians. Focusing on patient perspectives will ensure measures focus on what is important to patients and drive the improvement of patient outcomes. To accomplish this, the cooperative agreements prioritize the development of: outcome measures, including patient reported outcome and functional status measures; patient experience measures; care coordination measures; and measures of appropriate use of services, including measures of overuse.

For more information, search for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity: Measure Development for the Quality Payment Program on Grants.gov or visit our website, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html.

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Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter CMS Administrator @SeemaCMS, @CMSgov, and @CMSgovPress.

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Blue Ridge Beef Recalls Kitten Grind Raw Pet Food Lot#GA1102 Because of Possible Contamination - FDA Safety Alerts & Drug Recalls

Blue Ridge Beef of Eatonton, GA, is recalling lot#GA1102 of Kitten Grind raw pet food because of the potential of contamination with Salmonella and Listeria monocytogenes.

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FDA warns of fraudulent and unapproved flu products - FDA Press Releases

FDA warns of fraudulent and unapproved flu products

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FDA alerts health care professionals and patients not to use compounded drugs from Cantrell Drug Company; agency seeks action to stop production and distribution - FDA Press Releases

FDA is alerting not to use drug products produced by Cantrell Drug Company that were distributed nationwide.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance implementation of the new consumer Nutrition Facts label for foods - FDA Press Releases

Americans rely on the U.S. Food and Drug Administration to ensure that food labels contain updated nutritional information to help them make more informed food choices that lead to better health for themselves and their families. I’ve made nutrition one of my top priorities, and ensuring that consumers have accurate and science-based information concerning the link between diet and chronic diseases like diabetes, obesity and heart disease is part of that commitment. We need to advance new ways to use the science we’re learning about diet and nutrition as tools for reducing the burden of disease. Our update to the iconic Nutrition Facts label includes significant changes to help consumers make more informed dietary choices, and we are already seeing the new label on many products.

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