Dierbergs Markets Issues Allergy Alert on Undeclared Fish and Milk in Product - FDA Safety Alerts & Drug Recalls

St Louis-based Dierbergs is recalling various Deli Products with multiple use by dates in all retail stores because undeclared fish (anchovy) in a Caesar dressing and undeclared milk in 2 Santa Fe wraps. People who have allergies to fish and dairy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Federal judge orders New York smoked fish company to stop sales due to food safety violations - FDA Press Releases

A New York smoked fish company has been ordered by a federal court to stop selling its products, which were produced in a facility that was contaminated with Listeria monocytogenes (L. mono), until it can comply with food safety regulations.

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A Cumulative Deficit Laboratory Test–based Frailty Index: Personal and Neighborhood Associations - American Geriatric Society

Objectives

To explore the association between a newly developed cumulative laboratory-based frailty index (FI) and intrinsic (personal) and extrinsic (social, environmental) characteristics.

Design

Cross-sectional longitudinal study.

Setting

The third and fourth waves of the community-representative, five-county, 10-year Duke Established Populations for Epidemiologic Studies of the Elderly study, carried out in a health service-rich area.

Participants

Cognitively intact survivors of the third wave (N = 1,740), who provided blood samples for standard laboratory work.

Measurements

Biomarkers (n = 28) were measured to develop a cumulative deficit laboratory test–based FI (Duke FI) derived from standard laboratory tests: SMAC-24 chemistry panel, high-density lipoprotein cholesterol panel, and complete blood count. Information was gathered on scales assessing intrinsic characteristics (personal locus of control, life satisfaction, self-esteem, depressive symptomatology) and extrinsic characteristics (support received from and provided to family and friends, stressful life events, neighborhood disadvantage).

Results

The newly developed Duke FI had content, construct, concurrent, and predictive validity. In addition to sex, race, and income, the Duke FI was associated at the intrinsic level with locus of control, self-esteem, life satisfaction, and depressive symptomatology (each P < .01) and at the extrinsic level with provision (P < .01) and with receipt of instrumental help (P < .10), social stressors (P < .03), and neighborhood disadvantage (P < .01) in unadjusted analysis; race fully explained neighborhood disadvantage.

Conclusion

Intrinsic (personality) characteristics and personally close extrinsic characteristics (contacts with family and friends, personal stressors) are associated with laboratory test–based frailty, as is neighborhood disadvantage, although in this accessible, health service–rich environment, race fully explained association with neighborhood disadvantage, suggesting that interventions to reduce frailty in residents in such an environment should pay particular attention to characteristics that immediately affect the individual.

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FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas - FDA Press Releases

The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).

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FDA unveils plan to eliminate orphan designation backlog - FDA Press Releases

Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.

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A novel neutralizing monoclonal antibody targeting the N-terminal domain of the MERS-CoV spike protein

A novel neutralizing monoclonal antibody targeting the N-terminal domain of the MERS-CoV spike protein

Emerging Microbes & Infections 6, e60 (June 2017). doi:10.1038/emi.2017.50

Authors: Yingzhu Chen, Shuai Lu, Hao Jia, Yao Deng, Jianfang Zhou, Baoying Huang, Yueyang Yu, Jiaming Lan, Wenling Wang, Yongliang Lou, Kun Qin & Wenjie Tan

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PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira products.

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Global Lamsheng Kee Inc. Issues Allergy Alert on Undeclared Egg in Frozen Fish Tofu, Frozen Fried Fish Ball and Frozen White Fish Ball - FDA Safety Alerts & Drug Recalls

Global Lamsheng Kee Inc., Brooklyn, NY is recalling Frozen Fish Tofu, Frozen Fried Fish Ball and Frozen White Fish Ball because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA Tackles Drug Competition to Improve Patient Access - FDA Press Releases

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.

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Biosynthetic studies on terpenoids produced by Streptomyces - Journal of Antibiotics

Biosynthetic studies on terpenoids produced by Streptomyces

The Journal of Antibiotics 70, 811 (July 2017). doi:10.1038/ja.2017.12

Author: Tomohisa Kuzuyama

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Cytotoxic rearranged angucycline glycosides from deep sea-derived Streptomyces lusitanus SCSIO LR32 - Journal of Antibiotics

Cytotoxic rearranged angucycline glycosides from deep sea-derived Streptomyces lusitanus SCSIO LR32

The Journal of Antibiotics 70, 819 (July 2017). doi:10.1038/ja.2017.17

Authors: Xiangcheng Zhu, Yanwen Duan, Zhaomeng Cui, Zhen Wang, Zengxia Li, Yun Zhang, Jianhua Ju & Hongbo Huang

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New chlorinated xanthone and anthraquinone produced by a mangrove-derived fungus Penicillium citrinum HL-5126 - Journal of Antibiotics

New chlorinated xanthone and anthraquinone produced by a mangrove-derived fungus Penicillium citrinum HL-5126

The Journal of Antibiotics 70, 823 (July 2017). doi:10.1038/ja.2017.52

Authors: Ke-Yao He, Cheng Zhang, Yi-Ru Duan, Guo-Lei Huang, Chun-Yan Yang, Xing-Rui Lu, Cai-Juan Zheng & Guang-Ying Chen

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Nutritional control of antibiotic production by Streptomyces platensis MA7327: importance of l-aspartic acid - Journal of Antibiotics

Nutritional control of antibiotic production by Streptomyces platensis MA7327: importance of l-aspartic acid

The Journal of Antibiotics 70, 828 (July 2017). doi:10.1038/ja.2017.49

Authors: Maria Falzone, Emmanuel Crespo, Klarissa Jones, Gulaba Khan, Victoria L Korn, Amreen Patel, Mira Patel, Krishnaben Patel, Carrie Perkins, Sana Siddiqui, Drew Stenger, Eileen Yu, Michael Gelber, Robert Scheffler, Vasyl Nayda, Ariela Ravin, Ronica Komal, Jeffrey D Rudolf, Ben Shen, Vincent Gullo & Arnold L Demain

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Synthesis and biological evaluation of indole core-based derivatives with potent antibacterial activity against resistant bacterial pathogens - Journal of Antibiotics

Synthesis and biological evaluation of indole core-based derivatives with potent antibacterial activity against resistant bacterial pathogens

The Journal of Antibiotics 70, 832 (July 2017). doi:10.1038/ja.2017.55

Authors: Wei Hong, Jingyang Li, Zhe Chang, Xiaoli Tan, Hao Yang, Yifan Ouyang, Yanhui Yang, Sargit Kaur, Ian C Paterson, Yun Fong Ngeow & Hao Wang

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Sonochemical synthesis of pyrido[2,3-d:6,5-d′]-dipyrimidines catalyzed by [HNMP]+[HSO4]− and their antimicrobial activity studies - Journal of Antibiotics

Sonochemical synthesis of pyrido[2,3-d:6,5-d′]-dipyrimidines catalyzed by [HNMP]+[HSO4]− and their antimicrobial activity studies

The Journal of Antibiotics 70, 845 (July 2017). doi:10.1038/ja.2017.47

Authors: Hossein Naeimi, Asieh Didar, Zahra Rashid & Zohreh Zahraie

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Aurachin SS, a new antibiotic from Streptomyces sp. NA04227 - Journal of Antibiotics

Aurachin SS, a new antibiotic from Streptomyces sp. NA04227

The Journal of Antibiotics 70, 853 (July 2017). doi:10.1038/ja.2017.50

Authors: Mei Zhang, Cheng Long Yang, Yong Sheng Xiao, Bo Zhang, Xin Zhao Deng, Li Yang, Jing Shi, Yi Shuang Wang, Wei Li, Rui Hua Jiao, Ren Xiang Tan & Hui Ming Ge

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Unique prostate cancer-toxic polyketides from marine sediment-derived fungus Isaria felina - Journal of Antibiotics

Unique prostate cancer-toxic polyketides from marine sediment-derived fungus Isaria felina

The Journal of Antibiotics 70, 856 (July 2017). doi:10.1038/ja.2017.53

Authors: Olga F Smetanina, Anton N Yurchenko, Elena V Ivanets, Anatoly I Kalinovsky, Yuliya V Khudyakova, Sergey A Dyshlovoy, Gunhild von Amsberg, Ekaterina A Yurchenko & Shamil Sh Afiyatullov

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Heterologous expression of diverse propionyl-CoA carboxylases affects polyketide production in Escherichia coli - Journal of Antibiotics

Heterologous expression of diverse propionyl-CoA carboxylases affects polyketide production in Escherichia coli

The Journal of Antibiotics 70, 859 (July 2017). doi:10.1038/ja.2017.38

Authors: Gergana A Vandova, Robert V O'Brien, Brian Lowry, Thomas F Robbins, Curt R Fischer, Ronald W Davis, Chaitan Khosla, Colin JB Harvey & Maureen E Hillenmeyer

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Treatment of Sarcopenia with Bimagrumab: Results from a Phase II, Randomized, Controlled, Proof-of-Concept Study - American Geriatric Society

Objectives

To assess the effects of bimagrumab on skeletal muscle mass and function in older adults with sarcopenia and mobility limitations.

Design

A 24-week, randomized, double-blind, placebo-controlled, parallel-arm, proof-of-concept study.

Setting

Five centers in the United States.

Participants

Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m² or less for men and 5.67 kg/m² or less for women.

Intervention

Intravenous bimagrumab 30 mg/kg (n = 19) or placebo (n = 21).

Measurements

Change from baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, appendicular and total lean body mass, grip strength, gait speed, and 6-minute walk distance (6MWD).

Results

Thirty-two (80%) participants completed the study. TMV increased by Week 2, was sustained throughout the treatment period, and remained above baseline at the end of study in bimagrumab-treated participants, whereas there was no change with placebo treatment (Week 2: 5.15 ± 2.19% vs −0.34 ± 2.59%, P < .001; Week 4: 6.12 ± 2.56% vs 0.16 ± 3.42%, P < .001; Week 8: 8.01 ± 3.70% vs 0.35 ± 3.32%, P < .001; Week 16: 7.72 ± 5.31% vs 0.42 ± 5.14%, P < .001; Week 24: 4.80 ± 5.81% vs −1.01 ± 4.43%, P = .002). Participants with slower walking speed at baseline receiving bimagrumab had clinically meaningful and statistically significantly greater improvements in gait speed (mean 0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo at Week 16. Adverse events in the bimagrumab group included muscle-related symptoms, acne, and diarrhea, most of which were mild in severity and resolved by the end of study.

Conclusion

Treatment with bimagrumab over 16 weeks increased muscle mass and strength in older adults with sarcopenia and improved mobility in those with slow walking speed.

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Improving Management of Urinary Tract Infections in Older Adults: A Paradigm Shift or Therapeutic Nihilism? - American Geriatric Society

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the importance of the Drug Quality and Security Act and overseeing the safety of compounded drugs - FDA Press Releases

In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.

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Publix Recalls Publix Tropical Medley Mix Due to Possible Contamination with Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Publix Super Markets is issuing a voluntary recall for Publix Tropical Medley Mix because it may be adulterated with Listeria monocytogenes. Publix received notification of the potential contamination from our supplier of dried apricot, The 5.7oz clear plastic containers of the mix were sold from Publix retail produce departments in Florida, Georgia, South Carolina, Alabama, Tennessee and North Carolina with a UPC of 41415088586. All use by dates are being recalled.

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Polypharmacy and Gait Performance in Community–dwelling Older Adults - American Geriatric Society

Objectives

To examine the relationship between polypharmacy and gait performance during simple (normal walk (NW)) and complex (walking while talking (WWT)) locomotion.

Design

Cross-sectional.

Setting

Community.

Participants

Community-dwelling older adults (N = 482).

Measurements

Polypharmacy, defined as use of five or more medications and a cohort-specific alternate definition of eight or more medications, was examined. Velocity (cm/s) measured quantitatively during NW and WWT conditions.

Results

The 164 participants (34%) with polypharmacy of five or more medications were older (77.0 ± 6.6 vs 76.0 ± 6.4) and more likely to have hypertension, congestive heart failure, diabetes mellitus, myocardial infarction, and higher body mass index (BMI) and to have fallen within the last year than the remaining 318 without polypharmacy and walked 6 cm/s slower (P = .004) during NW and 4 cm/s slower during WWT (P = .07), adjusting for age, sex, and education. Group differences were not statistically significant after adjusting for comorbidities. Prevalence of polypharmacy of eight or more medications was 10%. This group walked 11 cm/s slower during NW (P < .001) and 8.6 cm/s slower during WWT (P = .01) than those without polypharmacy, adjusted for age, sex, and education. Participants taking eight or more medications had slower NW (8.5 cm/s; P = .01), and WWT (6.9 cm/s; P = .07), compared to those without polypharmacy, adjusting for comorbidities. Adjustments for BMI, high-risk drugs, falls, and comorbidities yielded slower NW (9.4 cm/s, P = .005) and WWT (7.9 cm/s, P = .04 among those with polypharmacy compared to those without polypharmacy).

Conclusion

These results suggest an association between polypharmacy and locomotion that medical comorbidities only partly explained.

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StaRI Aims to Overcome Knowledge Translation Inertia: The Standards for Reporting Implementation Studies Guidelines - American Geriatric Society

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ADM Animal Nutrition Recalls Rough-N-Ready Cattle Feed A specific lot of product contains elevated levels of monensin, could harm cattle - FDA Safety Alerts & Drug Recalls

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death.

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Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential For Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product.

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Teleflex’s (TFX) Vascular Solutions, Inc. Issues Recall of Venture® Catheters - FDA Safety Alerts & Drug Recalls

Teleflex Incorporated (NYSE: TFX), announces a worldwide recall of Venture® Catheters was voluntarily initiated by its Vascular Solutions, Inc. subsidiary on April 25, 2017. Vascular Solutions, Inc. is the manufacturer of Venture Catheters, which are designed for use in catheterization procedures, to direct, steer, control, and support a guidewire to access discrete regions of the coronary and peripheral vasculature. Two versions may also be used for manual delivery of saline solution or diagnostic contrast agents.

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Comment On: Geriatricians: The Super Specialist - American Geriatric Society

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FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease - FDA Press Releases

The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received.

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Advanced Pharma, Inc. d/b/a Avella of Houston Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Repacked and/or Compounded at its Houston Location as a Result of Hospira, Inc’s June 15, 2017 Recall of Such Products Due to a Potential Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance.

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Catechol-O-Methyltransferase Genotype and Gait Speed Changes over 10 Years in Older Adults - American Geriatric Society

Objectives

To determine the association between catechol-O-methyltransferase (COMT) genotype and 6-m walk time and to determine whether these associations are quadratic in nature, similar to previously reported U-shaped associations between dopamine and gait and cognition.

Design

Prospective cohort study.

Setting

Health, Aging and Body Composition Study.

Participants

Black (n = 850) and white (n = 1,352) men and women with a mean age of 73.5 ± 2.85 at baseline.

Measurements

Mixed models were used to assess the association between the COMT genotype and 6-m walk time, cross-sectionally and longitudinally over 10 years. Models were assessed unstratified and stratified according to race because allele distributions were different between white and black participants.

Results

There was a significant U-shaped association between COMT genotype and 6-m walk time: those with higher (Val/Val) and lower (Met/Met) dopamine slowed more over 10 years (0.22 ± 0.02 seconds per visit and 0.23 ± 0.02 seconds per visit, respectively) than those with the intermediate (Met/Val) dopamine (0.20 ± 0.02 seconds per visit) (P = .005). Stratified results showed a significant relationship in black (P = .01) but not white (P = .15) participants.

Conclusion

These findings indicate a role of dopaminergic regulation of gait speed in community-dwelling older adults and of prefrontal cortex involvement in gait performance. Future work should investigate the molecular integrity of dopaminergic networks and gait changes over time and structural changes in the brain with COMT and gait decline in older adults.

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Functional Impairment: An Unmeasured Marker of Medicare Costs for Postacute Care of Older Adults - American Geriatric Society

Objectives

To assess the effects of preadmission functional impairment on Medicare costs of postacute care up to 365 days after hospital discharge.

Design

Longitudinal cohort study.

Setting

Health and Retirement Study (HRS).

Participants

Nationally representative sample of 16,673 Medicare hospitalizations of 8,559 community-dwelling older adults from 2000 to 2012.

Measurements

The main outcome was total Medicare costs in the year after hospital discharge, assessed according to Medicare claims data. The main predictor was functional impairment (level of difficulty or dependence in activities of daily living (ADLs)), determined from HRS interview preceding hospitalization. Multivariable linear regression was performed, adjusted for age, race, sex, income, net worth, and comorbidities, with clustering at the individual level to characterize the association between functional impairment and costs of postacute care.

Results

Unadjusted mean Medicare costs for 1 year after discharge increased with severity of impairment in a dose-response fashion (P < .001 for trend); 68% had no functional impairment ($25,931), 17% had difficulty with one ADL ($32,501), 7% had dependency in one ADL ($39,928), and 8% had dependency in two or more ADLs ($45,895). The most severely impaired participants cost 77% more than those with no impairment; adjusted analyses showed attenuated effect size (33% more) but no change in trend. Considering costs attributable to comorbidities, only three conditions were more expensive than severe functional impairment (lymphoma, metastatic cancer, paralysis).

Conclusion

Functional impairment is associated with greater Medicare costs for postacute care and may be an unmeasured but important marker of long-term costs that cuts across conditions.

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H-E-B Issues Recall for Undeclared Allergen. H-E-B Creamy Creations Cherry Vanilla Light Churn Style Ice Cream being recalled from five stores for undeclared allergen - FDA Safety Alerts & Drug Recalls

H-E-B, committed to the quality of its products, is issuing a recall for H-E-B Creamy Creations Cherry Vanilla Light Churn Style Half-Gallon Ice Cream from five potentially impacted stores because it may contain an undeclared nut allergen. There have been no reported illnesses related to this recall.

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Using Chief Complaint in Addition to Diagnosis Codes to Identify Falls in the Emergency Department - American Geriatric Society

Objectives

To compare incidence of falls in an emergency department (ED) cohort using a traditional International Classification of Diseases, Ninth Revision (ICD-9) code–based scheme and an expanded definition that included chief complaint information and to examine the clinical characteristics of visits “missed” in the ICD-9-based scheme.

Design

Retrospective electronic record review.

Setting

Academic medical center ED.

Participants

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

Measurements

Two fall definitions were applied (individually and together) to the cohort: an ICD-9-based definition and a chief complaint definition. Admission rates and 30-day mortality (per encounter) were measured for each definition.

Results

Twenty-three thousand eight hundred eighty older adult visits occurred during the study period. Using the most-inclusive definition (ICD-9 code or chief complaint indicating a fall), 4,363 visits (18%) were fall related. Of these visits, 3,506 (80%) met the ICD-9 definition for a fall-related visit, and 2,664 (61%) met the chief complaint definition. Of visits meeting the chief complaint definition, 857 (19.6%) were missed when applying the ICD-9 definition alone. Encounters missed using the ICD-9 definition were less likely to lead to an admission (42.9%, 95% confidence interval (CI) = 39.7–46.3%) than those identified (54.4%, 95% CI = 52.7–56.0%).

Conclusion

Identifying individuals in the ED who have fallen based on diagnosis codes underestimates the true burden of falls. Individuals missed according to the code-based definition were less likely to have been admitted than those who were captured. These findings call attention to the value of using chief complaint information to identify individuals who have fallen in the ED—for research, clinical care, or policy reasons.

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HIV-1 gp41-targeting fusion inhibitory peptides enhance the gp120-targeting protein-mediated inactivation of HIV-1 virions

HIV-1 gp41-targeting fusion inhibitory peptides enhance the gp120-targeting protein-mediated inactivation of HIV-1 virions

Emerging Microbes & Infections 6, e59 (June 2017). doi:10.1038/emi.2017.46

Authors: Qianqian Qi, Qian Wang, Weizao Chen, Lanying Du, Dimiter S Dimitrov, Lu Lu & Shibo Jiang

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Astroviruses in bats, Madagascar

Astroviruses in bats, Madagascar

Emerging Microbes & Infections 6, e58 (June 2017). doi:10.1038/emi.2017.47

Authors: Camille Lebarbenchon, Beza Ramasindrazana, Léa Joffrin, Sandra Bos, Erwan Lagadec, Gildas Le Minter, Yann Gomard, Pablo Tortosa, David A Wilkinson, Steven M Goodman & Patrick Mavingui

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Primary osteomyelitis caused by an NDM-1-producing K. pneumoniae strain of the highly virulent sequence type 23

Primary osteomyelitis caused by an NDM-1-producing K. pneumoniae strain of the highly virulent sequence type 23

Emerging Microbes & Infections 6, e57 (June 2017). doi:10.1038/emi.2017.43

Authors: Fabrice Compain, Alexis Vandenberghe, Marie Gominet, Nathalie Genel, David Lebeaux, Astrid Ramahefasolo, Isabelle Podglajen & Dominique Decré

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Longitudinal study of Middle East Respiratory Syndrome coronavirus infection in dromedary camel herds in Saudi Arabia, 2014–2015

Longitudinal study of Middle East Respiratory Syndrome coronavirus infection in dromedary camel herds in Saudi Arabia, 2014–2015

Emerging Microbes & Infections 6, e56 (June 2017). doi:10.1038/emi.2017.44

Authors: Maged Gomaa Hemida, Abdulmohsen Alnaeem, Daniel KW Chu, Ranawaka APM Perera, Samuel MS Chan, Faisal Almathen, Emily Yau, Brian CY Ng, Richard J Webby, Leo LM Poon & Malik Peiris

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Differences in sequences between HBV-relaxed circular DNA and covalently closed circular DNA

Differences in sequences between HBV-relaxed circular DNA and covalently closed circular DNA

Emerging Microbes & Infections 6, e55 (June 2017). doi:10.1038/emi.2017.41

Authors: Magda Rybicka, Anna Woziwodzka, Tomasz Romanowski, Piotr Stalke, Marcin Dręczewski & Krzysztof Piotr Bielawski

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An outbreak of echovirus 18 encephalitis/meningitis in children in Hebei Province, China, 2015

An outbreak of echovirus 18 encephalitis/meningitis in children in Hebei Province, China, 2015

Emerging Microbes & Infections 6, e54 (June 2017). doi:10.1038/emi.2017.39

Authors: Xiangpeng Chen, Jingjie Li, Jiayun Guo, Wenbo Xu, Suzhen Sun & Zhengde Xie

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Coronavirus HKU15 in respiratory tract of pigs and first discovery of coronavirus quasispecies in 5′-untranslated region

Coronavirus HKU15 in respiratory tract of pigs and first discovery of coronavirus quasispecies in 5′-untranslated region

Emerging Microbes & Infections 6, e53 (June 2017). doi:10.1038/emi.2017.37

Authors: Patrick CY Woo, Susanna KP Lau, Chi-Ching Tsang, Candy CY Lau, Po-Chun Wong, Franklin WN Chow, Jordan YH Fong & Kwok-Yung Yuen

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Infections of horses and shrews with Bornaviruses in Upper Austria: a novel endemic area of Borna disease

Infections of horses and shrews with Bornaviruses in Upper Austria: a novel endemic area of Borna disease

Emerging Microbes & Infections 6, e52 (June 2017). doi:10.1038/emi.2017.36

Authors: Herbert Weissenböck, Zoltán Bagó, Jolanta Kolodziejek, Barbara Hager, Günter Palmetzhofer, Ralf Dürrwald & Norbert Nowotny

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Reply To: Higher Intelligence and Later Maternal Age: Which Way Does the Causal Direction Go? - American Geriatric Society

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JFC International Inc. Issues Missing English Label and Allergy Alert on Undeclared Wheat, Soybean, and Fish (Bonito) in Futaba Sesame Hijiki Rice Seasoning - FDA Safety Alerts & Drug Recalls

JFC International Inc. of Los Angeles, CA is voluntarily recalling a rice seasoning product because it was found to be missing the English Product Label for sale in the United States. In addition, due to the missing English label, the product has undeclared Wheat, Soybean, and Fish (Bonito) allergens. People who have allergies to wheat, soybeans, or fish (bonito) run the risk of a serious life-threatening allergic reaction if they consume the product. No illnesses have been reported to date in connection with this problem.

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United Natural Trading LLC Announces Voluntary Recall of Products Containing Organic and Natural Chopped Dates Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

United Natural Trading LLC, Edison, NJ, is voluntarily recalling a limited number of products containing Organic and Natural dates (see below) and sold under the Nature’s Promise, Woodstock, Market Basket, and Wholesome Pantry brands due to a possible health risk from 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 symptoms.

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Batch of Fat Cat Purry-Purry Sauce Hot Sauce Recalled Due to Undeclared Allergens in Per-Peri Pepper Ingredient - FDA Safety Alerts & Drug Recalls

A single production batch of Fat Cat Purry-Purry Sauce Hot Sauce, sold specifically to Winn-Dixie Supermarkets, BI-LO Supermarkets and Harvey’s Supermarkets in the Southeastern U.S., has been recalled due to a potential peanut contamination found in the product. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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U.S. Marshals seize adulterated food from a Minnesota warehouse - FDA Press Releases

The U.S. Food and Drug Administration announced that on June 15, the U.S. Marshals Service seized food products held at Professional Warehouse and Distribution, Inc., in St. Paul, Minnesota. The food products seized are worth approximately $73,000 and include, among other things, barley flour, spices, pasta, dried beans, tea and cookies.

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House of Thaller Recalls Selected Pine Nut Hummus Products Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

House of Thaller, a Knoxville Tennessee company, is voluntarily recalling selected 10 ounce packages of Hummus with Pine Nut Topping, because an ingredient supplier notified us that their ingredient has the potential to be contaminated with Listeria monocytogenes.

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Recall Expansion in New Jersey on Fewer than 650 units of Ava’s Brand Organic Roasted Unsalted Cashews and Organic Roasted Unsalted Almonds - FDA Safety Alerts & Drug Recalls

Hampton Farms is expanding its voluntary recall to include Ava’s Brand Organic Roasted Unsalted Cashews and Ava’s Brand Organic Roasted Unsalted Almonds distributed only in New Jersey. This is the result of a recall expansion from Hampton Farms’ supplier, Hudson Valley Foods, Inc. of Highland, NY advising Hampton Farms that ingredients sold to the company have the potential to be contaminated with Listeria monocytogenes.

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Higher Intelligence and Later Maternal Age: Which Way Does the Causal Direction Go? - American Geriatric Society

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Kabir’s Bakery issues allergy alert on undeclared milk in “Kabir’s Bakery Cinnamon Twist” and “Kabir’s Bakery Cinnamon Raisin Danish” in four ounce plastic packages, all container codes. - FDA Safety Alerts & Drug Recalls

Kabir’s Bakery of Brooklyn, NY is recalling “Kabir’s Bakery Cinnamon Twist“ and “Kabir’s Bakery Cinnamon Raisin Danish” in four ounce plastic packages, all container codes, due to the presence of undeclared milk. Consumers who are allergic to milk run the risk of serious life threatening allergic reactions if they consume this product

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Rikki USA, Inc. Issues Allergy Alert on Undeclared Milk in Masa’s Gourmet Sweet and Sour Sauce, Masa’s Gourmet Curry Coconut Sauce and Masa’s Gourmet Pulled Pork BBQ Sauce - FDA Safety Alerts & Drug Recalls

Rikki USA, Inc. of Redmond, WA is recalling Masa’s Gourmet Sweet and Sour Sauce, Masa’s Gourmet Curry Coconut Sauce and Masa’s Gourmet Pulled Pork BBQ Sauce because it contains 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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Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps for Potential Electrical Test Failure Code - FDA Safety Alerts & Drug Recalls

Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corp. for a potential electrical test failure code.

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Discharge Against Medical Advice of Elderly Inpatients in the United States - American Geriatric Society

Discharge against medical advice (DAMA) is associated with greater risk of hospital readmission and higher morbidity, mortality, and costs, but with a rapidly increasing elderly inpatient population, there is a lack of national data on DAMA in this subgroup. The National Inpatient Sample (2003–2013 for trends, 2013 for multivariable analysis, n = 29,290,852) was used to describe trends in DAMA in elderly inpatients, to study diagnosis codes associated with admission, and to assess factors associated with DAMA using multivariable logistic regression. Odds ratios (ORs) and 95% confidence intervals (CIs) are reported for risk factors of interest. Although DAMA rates in individuals aged 65 and older were one fourth of those found in individuals aged 18 to 64, an increasing trend was found in both groups. From 2003 to 2013, rates increased in individuals aged 18 to 64 (from 1.44% to 1.78%) and in those aged 65 and older (from 0.37% to 0.42% (both P < .001). In both age groups, individuals admitted for mental illness had the highest risk of DAMA. Factors associated with higher adjusted odds of DAMA were generally similar between age groups, although risk of DAMA was higher in elderly adults than in those aged 18 to 64 for blacks (OR 1.65, 95% CI 1.49–1.82 vs OR 1.16, 95% CI 1.12–1.20), Hispanics (OR 1.58, 95% CI 1.41–1.77 vs OR 0.83, 95% CI 0.79–0.87), and those in the lowest income quartile (OR 1.57, 95% CI 1.43–1.72 vs OR 1.12, 95% CI 1.08–1.17), suggesting that race/ethnicity and poverty are more pronounced as risk factors for DAMA in elderly inpatients.

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Update to Voluntary Recall of Eliquis® (apixaban) 5 mg Tablets (#HN0063) - Recall to retail/dispensing level only - FDA Safety Alerts & Drug Recalls

On June 10, Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquis 5 mg tablets. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a single customer complaint that a bottle labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets. No other lots are impacted by this recall.

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United Pet Group Expands Voluntary Recall of Multiple Brands of Rawhide Chew Products for Dogs to Also Include Private Label Brands Due to Possible Chemical Contamination - FDA Safety Alerts & Drug Recalls

United Pet Group, a division of Spectrum Brands, Inc. is voluntarily expanding its recall of multiple brands of packages of rawhide dog chew products to include our retail partners’ private label brands. The recall involves the brands and products described below.

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Alvogen Issues Voluntary Nationwide Recall of Clindamycin Injection Due to a Potential for a Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

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Vitakraft Sun Seed Issues Voluntary Recall of Certain Rabbit and Macaw Diets Due To Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling certain Sunseed Parrot Fruit & Vegetable diet and Sunseed SunSations Rabbit Food due to a potential Listeria monocytogenes contamination. 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. Healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Chic-A-Peas, LLC Recalls Product Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Chic-a-Peas, LLC is voluntarily recalling a limited number of Chic-a-Peas Baked Crunchy Chickpeas 2 oz. packages because the product has 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 high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Willis Ocean Inc Issues Alert on Uneviscerated Scomber Fish - FDA Safety Alerts & Drug Recalls

Willis Ocean Inc., Brooklyn, NY, is recalling its “the duck” brand “frozen steamed scomber fish”, because the product was found to be uneviscerated. The steamed scomber fish were distributed nationwide through retail stores.

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NOW Health Group Inc. Expands Voluntary Recall of Ellyndale® Nutty Infusions™ Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is expanding the voluntary recall of Ellyndale® Nutty Infusions™ Roasted Cashew Butter – Product Code E0540, Lot# 2125155, and Ginger Wasabi Cashew Butter -- Product Code E0541, Lot# 2124118, to include Roasted Almond Butter – Product Code E0545, Lot# 2124119, and Mango Chili Cashew Butter – Product Code E0542, Lot# 2125156. An FDA follow-up inspection of the Nutty Infusions supplier’s facility revealed these lots 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 high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Hospira Issues a Voluntary Nationwide Recall For 8.4% Sodium Bicarbonate Injection, USP, Neut tm (Sodium Bicarbonate 4% Additive Solution), QUELICIN tm (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due To a Potential For Lack Of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

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Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency - FDA Safety Alerts & Drug Recalls

Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of compounded NitroGlycerin Injection which would lead to a lower dose being administered.

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New England Natural Bakers Issues Voluntary Recall Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

NEW ENGLAND NATURAL BAKERS of Greenfield MA, is issuing a voluntary recall, the company has been notified by an ingredient supplier that an ingredient used in these products has the potential to be contaminated with Listeria monocytogenes.

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Teva Pharmaceuticals, USA Extends Voluntary Nationwide Recall to Consumer/User Level for One Lot of Paliperidone Extended-Release Tablets, 3mg, 90 Count Bottles Distributed Under the Actavis Pharma Inc. Label Due to Dissolution Test Failure - FDA Safety Alerts & Drug Recalls

Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the CONSUMER/USER level.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the 2016 National Youth Tobacco Survey results - FDA Press Releases

While the latest numbers from the 2016 National Youth Tobacco Survey are encouraging, it is critical that we work to ensure this downward trend continues over the long term across all tobacco products. Every day in the U.S., more than 2,500 youth under the age of 18 smoke their first cigarette and more than 400 youth become daily cigarette smokers. It is also clear from these most recent numbers that youth are continuing to experiment with, or becoming regular users of, a wide range of other tobacco products.

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Sonar Products ordered to cease operations, Stratus Pharmaceuticals ordered to cease distributing unapproved drugs - FDA Press Releases

Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.

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Kroger Expands Recall of 12 oz. packages of Simple Truth Dry Roasted Macadamia Nuts because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

The Kroger Co. (NYSE: KR) today announced it has expanded the recall of its 12 oz. packages of Simple Truth Dry Roasted Macadamia Nuts due to potential Listeria monocytogenes contamination. 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.

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Gomacro Recalls Limited Number of Macrobars and Thrive Bars Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

GoMacro, of Viola, Wis., is recalling a limited number of MacroBars and Thrive Bars 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 high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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Bulletproof 360, Inc. Recalls Collagen Protein Bars and Bites Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

– Bulletproof 360, Inc. (“Bulletproof”) of Bellevue, Washington is recalling five Collagen Protein Bar and Bite products 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.

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Wildway LLC Issues Voluntary Recall of Certain Grain-Free Granola Products - FDA Safety Alerts & Drug Recalls

Wildway LLC is voluntarily recalling certain grain-free granola codes, because the Company has been notified by an ingredient supplier that an ingredient used in these products has the potential to be contaminated with Listeria monocytogenes.

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Loving Pets Voluntarily Recalls Limited Lot Numbers of Air-Puffed Dog Treats Because of Possible Salmonella Health Risk - FDA Safety Alerts & Drug Recalls

Loving Pets of Cranbury, NJ is voluntarily recalling a limited number of dog treats because of 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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Phillips Company Issues Voluntary Worldwide Recall of All Topical Products Due to Concerns of Manufacturing Practices - FDA Safety Alerts & Drug Recalls

Phillips Company is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed distributed by Phillips Company, with business offices located in Sun City, Arizona, to the retail level. The products are being recalled after an FDA inspection found significant manufacturing practices that calls into question the safety, identity, strength, quality and purity of unexpired drug products made at the firm during the past three years.

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Bristol-Myers Squibb Voluntarily Recalls One Lot of Eliquis (apixaban) 5 mg Tablets - FDA Safety Alerts & Drug Recalls

Bristol-Myers Squibb Company (NYSE: BMY) is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.

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Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties - FDA Press Releases

Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction.

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Giant Eagle Voluntarily Recalls Select Items Due to an Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls

Giant Eagle, Inc. has announced a voluntary recall of Market District Toasted Crumb Tilapia and Giant Eagle Toasted Crumb Tilapia sold fresh from the seafood department of its supermarkets, and Giant Eagle Breaded Chicken Breast sold in the prepared foods department, due to an undeclared milk allergen. People who have an allergy, or severe sensitivity to milk, may experience serious or life-threatening allergic reactions if they consume these products.

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Slade Gorton Co. Inc. Issues Allergy Alert On Undeclared Milk - FDA Safety Alerts & Drug Recalls

Slade Gorton, Boston, MA is recalling the following products because they may 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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CC Kitchens Announces Recall of Limited Number of Salad and Slaw Kits Containing Leafy Greens Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

CC Kitchens is recalling a limited number of salad and slaw kits due to a possible health risk from Listeria. No contamination has been reported to have occurred on any product, nor have any illnesses been reported to date in association with the recall. Rather, the recall was initiated by the processor of certain leafy greens in an abundance of caution due to instances of positive test results for the presence of Listeria being identified by the processor during environmental testing of portions of their facility.

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Dietary Pattern Associated with Frailty: Results from Nutrition and Health Survey in Taiwan - American Geriatric Society

Objectives

To investigate whether dietary patterns are associated with frailty phenotypes in an elderly Taiwanese population.

Design

Cross-sectional.

Setting

Nutrition and Health Survey in Taiwan (NAHSIT), 2014–2016.

Participants

Noninstitutionalized Taiwanese nationals aged 65 years and older enrolled in the NAHSIT (N = 923).

Measurements

Dietary intake was assessed using a 79-item food-frequency questionnaire (FFQ). Presence of 5 frailty phenotypes was determined using modified Fried criteria and are summed into a frailty score. Using data from the NAHSIT (2014–15), reduced rank regression was used to find a dietary pattern that explained maximal degree of variation of the frailty scores. Logistic regression models were used to estimate the association between frailty and dietary pattern. The findings were validated with data from 2016.

Results

The derived dietary pattern was characterized with a high consumption of fruit, nuts and seeds, tea, vegetables, whole grains, shellfish, milk, and fish. The prevalence of frailty was 7.8% and of prefrailty was 50.8%, defined using the modified Fried criteria. Using data from the NAHSIT (2014–15), the dietary pattern score showed an inverse dose-response relationship with prevalence of frailty and pre-frailty. Individuals in the second dietary pattern tertile were one-third as likely to be frail as those in the first tertile (adjusted odds ratio (aOR) = 0.32, 95% confidence interval (CI) = 0.12−0.85), and those in the third tertile were 4% as likely to be frail as those in the first tertile (aOR = 0.04, 95% CI = 0.01−0.18). The dietary pattern score estimated using FFQ data from the NAHSIT 2016 was also significantly and inversely associated with frailty.

Conclusion

Individuals with a dietary pattern with more phytonutrient-rich plant foods, tea, omega-3-rich deep-sea fish, and other protein-rich foods such as shellfish and milk had a reduced prevalence of frailty. Further research is necessary to confirm these findings and investigate whether related dietary interventions can reduce frailty in older adults.

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United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew Products for Dogs Due to Possible Chemical Contamination - FDA Safety Alerts & Drug Recalls

United Pet Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S. The recall involves the brands and products described below.

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Club Chef LLC Announces Recall of Limited Number of Snack Kits - FDA Safety Alerts & Drug Recalls

Club Chef LLC is recalling a limited number of cases of Retail Snacks due to a possible health risk from Listeria.

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The Geriatrician Circa 2030 - American Geriatric Society

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Periodontal Disease Associated with Higher Risk of Dementia: Population-Based Cohort Study in Taiwan - American Geriatric Society

Objectives

To determine the magnitude and temporal aspect of the effect of poor dental health and periodontal disease (PD) on dementia.

Design

Retrospective cohort study

Setting

Taiwan National Health Insurance Research Database.

Participants

Individuals with newly diagnosed PD (N = 182,747)

Measurements

Participants were followed from January 1, 2000, to December 31, 2010. Participants were assigned to dental prophylaxis, intensive periodontal treatment, tooth extraction, or no treatment, according to International Classification of Diseases codes and PD treatment codes. The incidence rate of dementia of the groups was compared. The association between PD and dementia was analyzed using Cox regression, with adjustments for age, sex, monthly income, residential urbanicity, and comorbidities.

Results

The incidence of dementia was significantly higher in the group with PD that did not receive treatment (0.76% per year) and in the group that had teeth extracted (0.57% per year) than in the group that underwent intensive PD treatment (0.35% per year) and the group that received dental prophylaxis (0.39% per year) (P < .001). After adjusting for confounders, the Cox proportional hazards model revealed a higher risk of dementia in the group with PD who did not undergo treatment (hazard ratio (HR) = 1.14, 95% confidence interval (CI) = 1.04–1.24) and the group that had teeth extracted (HR = 1.10, 95% CI = 1.04–1.16) than in the group that received dental prophylaxis.

Conclusion

Subjects who had more severe PD or did not receive periodontal treatment were at greater risk of developing dementia.

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Functional Impairment and Risk of Venous Thrombosis in Older Adults - American Geriatric Society

Objectives

To determine the role of age-specific risk factors for thrombosis in older age, such as functional impairment.

Design

Case-control study.

Setting

The Age and Thrombosis—Acquired and Genetic risk factors in the Elderly Study, a two-center study conducted in the Netherlands and the United States from 2008 to 2011.

Participants

Individuals aged 70 and older with a first-time deep venous thrombosis in the leg or pulmonary embolism (n = 401) and controls aged 70 and older (n = 431) without a history of thrombosis. Exclusion criteria were active malignancy and severe cognitive disorders.

Measurements

The thrombotic risk associated with functional impairment, defined as impairment in two or more activities of daily living (ADLs), impaired mobility (inability to walk outside), sedentary lifestyle (≥20 h/d sleeping or sitting), and low handgrip strength (<15th percentile), was assessed. Odds ratios (ORs) adjusted for age, sex, and study center with 95% confidence intervals (95% CI) and population attributable risks (PAR) were calculated.

Results

Risk of venous thrombosis was 2.9 times greater (OR = 2.9, 95% CI = 1.6–5.3) in individuals with impairment in ADLs, three times as great (OR = 3.0, 95% CI = 1.9–4.7) in those with impaired mobility, four times as great (OR = 4.0, 95% CI = 2.5–6.3) in those with a sedentary life style, and 2.3 times as great (OR = 2.3, 95% CI = 1.5–3.4) in those with weak handgrip strength. PARs were 8% for ADL disability, 13% for inability to walk outside for 15 minutes, 29% for sedentary lifestyle, and 13% for weak hand grip strength.

Conclusion

In individuals aged 70 and older, functional impairments are a major risk factor for venous thrombosis. These findings may help providers caring for older people be more aware of venous thrombosis risk.

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FDA requests removal of Opana ER for risks related to abuse - FDA Press Releases

Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

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Happy Sprout Inc. Recalls Soybean Sprouts Due To Possible Health Risk - FDA Safety Alerts & Drug Recalls

Happy Sprout Inc. of Springfield, VA is voluntarily recalling all packages of soybean sprouts because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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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Proton Pump Inhibitors and Risk of Mild Cognitive Impairment and Dementia - American Geriatric Society

Objectives

To examine the risk associated with the use of proton pump inhibitors (PPIs) of conversion to mild cognitive impairment (MCI), dementia, and specifically Alzheimer's disease (AD).

Design

Observational, longitudinal study.

Setting

Tertiary academic Alzheimer's Disease Centers funded by the National Institute on Aging.

Participants

Research volunteers aged 50 and older with two to six annual visits; 884 were taking PPIs at every visit, 1,925 took PPIs intermittently, and 7,677 never reported taking PPIs. All had baseline normal cognition or MCI.

Measurements

Multivariable Cox regression analyses evaluated the association between PPI use and annual conversion of baseline normal cognition to MCI or dementia or annual conversion of baseline MCI to dementia, controlling for demographic characteristics, vascular comorbidities, mood, and use of anticholinergics and histamine-2 receptor antagonists.

Results

Continuous (always vs never) PPI use was associated with lower risk of decline in cognitive function (hazard ratio (HR) = 0.78, 95% confidence interval (CI) =0.66–0.93, P = .005) and lower risk of conversion to MCI or AD (HR = 0.82, 95% CI = 0.69–0.98, P = .03). Intermittent use was also associated with lower risk of decline in cognitive function (HR = 0.84, 95% CI = 0.76–0.93, P = .001) and risk of conversion to MCI or AD (HR = 0.82, 95% CI = 0.74–0.91, P = .001). This lower risk was found for persons with normal cognition or MCI.

Conclusion

Proton pump inhibitors were not associated with greater risk of dementia or of AD, in contrast to recent reports. Study limitations include reliance on self-reported PPI use and lack of dispensing data. Prospective studies are needed to confirm these results to guide empirically based clinical treatment recommendations.

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Comparative epidemiology of Middle East respiratory syndrome coronavirus (MERS-CoV) in Saudi Arabia and South Korea

Comparative epidemiology of Middle East respiratory syndrome coronavirus (MERS-CoV) in Saudi Arabia and South Korea

Emerging Microbes & Infections 6, e51 (June 2017). doi:10.1038/emi.2017.40

Authors: Xin Chen, Abrar Ahmad Chughtai, Amalie Dyda & Chandini Raina MacIntyre

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Human infections with novel reassortant H5N6 avian influenza viruses in China

Human infections with novel reassortant H5N6 avian influenza viruses in China

Emerging Microbes & Infections 6, e50 (June 2017). doi:10.1038/emi.2017.38

Authors: Ye Zhang, Minmei Chen, Yiwei Huang, Wenfei Zhu, Lei Yang, Lidong Gao, Xiaodan Li, Fuyin Bi, Chaoyang Huang, Ning Kang, Hengjiao Zhang, Zi Li, Hong Bo, Dayan Wang & Yuelong Shu

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Additional molecular testing of saliva specimens improves the detection of respiratory viruses

Additional molecular testing of saliva specimens improves the detection of respiratory viruses

Emerging Microbes & Infections 6, e49 (June 2017). doi:10.1038/emi.2017.35

Authors: Kelvin KW To, Lu Lu, Cyril CY Yip, Rosana WS Poon, Ami MY Fung, Andrew Cheng, Daniel HK Lui, Deborah TY Ho, Ivan FN Hung, Kwok-Hung Chan & Kwok-Yung Yuen

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Identification and evaluation of the novel immunodominant antigen Rv2351c from Mycobacterium tuberculosis

Identification and evaluation of the novel immunodominant antigen Rv2351c from Mycobacterium tuberculosis

Emerging Microbes & Infections 6, e48 (June 2017). doi:10.1038/emi.2017.34

Authors: Xuezhi Wang, Shuangshuang Chen, Yongjuan Xu, Huajun Zheng, Tongyang Xiao, Yuqing Li, Xing Chen, Mingxiang Huang, Haifeng Zhang, Xijing Fang, Yi Jiang, Machao Li, Haican Liu & Kanglin Wan

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Mycobacterium tuberculosis Beijing genotype family strain isolated from naturally infected plateau zokor (Myospalax baileyi) in China

Mycobacterium tuberculosis Beijing genotype family strain isolated from naturally infected plateau zokor (Myospalax baileyi) in China

Emerging Microbes & Infections 6, e47 (June 2017). doi:10.1038/emi.2017.33

Authors: Lin Sun, Xiang Chen, Wenhai Zhang, Gencheng Huang, Yuanyuan Zhang, Zhengzhong Xu, Baofa Yin, Wanhong Wei, Xinan Jiao & Kanglin Wan

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T-cell-dependent mechanisms promote Ebola VLP-induced antibody responses, but are dispensable for vaccine-mediated protection

T-cell-dependent mechanisms promote Ebola VLP-induced antibody responses, but are dispensable for vaccine-mediated protection

Emerging Microbes & Infections 6, e46 (June 2017). doi:10.1038/emi.2017.31

Authors: Christopher L Cooper, Karen A Martins, Sabrina M Stronsky, David P Langan, Jesse Steffens, Sean Van Tongeren & Sina Bavari

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Predictors of seropositivity for human herpesvirus type 8 in patients with mild cirrhosis

Predictors of seropositivity for human herpesvirus type 8 in patients with mild cirrhosis

Emerging Microbes & Infections 6, e45 (June 2017). doi:10.1038/emi.2017.32

Authors: Kuo-Chih Tseng, Ming-Nan Lin, Tang-Yuan Chu, Jen-Pi Tsai & Cheng-Chuan Su

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Isolation and characterization of Listeria species from rodents in natural environments in China

Isolation and characterization of Listeria species from rodents in natural environments in China

Emerging Microbes & Infections 6, e44 (June 2017). doi:10.1038/emi.2017.28

Authors: Yan Wang, Liang Lu, Ruiting Lan, Joelle K Salazar, Jingli Liu, Jianguo Xu & Changyun Ye

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Seroprevalence of neutralizing antibodies against adenovirus type 14 and 55 in healthy adults in Southern China

Seroprevalence of neutralizing antibodies against adenovirus type 14 and 55 in healthy adults in Southern China

Emerging Microbes & Infections 6, e43 (June 2017). doi:10.1038/emi.2017.29

Authors: Xuehua Zheng, Xia Rong, Ying Feng, Xikui Sun, Liang Li, Qian Wang, Min Wang, Wenkuan Liu, Chufang Li, Yiyu Yang, Rong Zhou, Jiahai Lu, Liqiang Feng & Ling Chen

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Recombinant feline parvovirus infection of immunized tigers in central China

Recombinant feline parvovirus infection of immunized tigers in central China

Emerging Microbes & Infections 6, e42 (June 2017). doi:10.1038/emi.2017.25

Authors: Xingang Wang, Tongyi Li, Hongying Liu, Jimei Du, Feng Zhou, Yanming Dong, Xiuyuan He, Yongtao Li & Chuanqing Wang

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West Nile virus infection in suspected febrile typhoid cases in Xinjiang, China

West Nile virus infection in suspected febrile typhoid cases in Xinjiang, China

Emerging Microbes & Infections 6, e41 (June 2017). doi:10.1038/emi.2017.27

Authors: Lei Cao, Shihong Fu, Zhi Lv, Chengjun Tang, Shiheng Cui, Xiaolong Li, Xiaoyan Gao, Minghua Li, Yuxi Cao, Wenwen Lei, Ying He, Huanyu Wang & Guodong Liang

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A novel preventive strategy against HIV-1 infection: combinatorial use of inhibitors targeting the nucleocapsid and fusion proteins

A novel preventive strategy against HIV-1 infection: combinatorial use of inhibitors targeting the nucleocapsid and fusion proteins

Emerging Microbes & Infections 6, e40 (June 2017). doi:10.1038/emi.2017.26

Authors: Yu Yang, Jingyu Zhu, Matthew Hassink, Lisa M Miller Jenkins, Yanmin Wan, Daniel H Appella, Jianqing Xu, Ettore Appella & Xiaoyan Zhang

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Star Snacks Co. is voluntarily recalling two lots of Southern Grove Cashew Halves and Pieces with Sea Salt due to the potential presence of glass pieces - FDA Safety Alerts & Drug Recalls

Star Snacks Co. of Jersey City, NJ is voluntarily recalling two lots of Southern Grove Cashew Halves and Pieces with Sea Salt due to the potential presence of glass pieces.

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FDA Investigates Findings of Hepatitis A Linked to Frozen Tuna - FDA Safety Alerts & Drug Recalls

Please find more information about the Outbreak of Hepatitis A Illnesses Linked to Raw Scallops here: http://ift.tt/2qLzbpp

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Reply to: Estimating the Full Value of the High-Dose Influenza Vaccine - American Geriatric Society

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Estimating the Full Value of High-Dose Influenza Vaccine - American Geriatric Society

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Male Centenarians: How and Why Are They Different from Their Female Counterparts? - American Geriatric Society

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The Geriatrics 5M's: A new way of communicating what we do - American Geriatric Society

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Seventeen Hours - American Geriatric Society

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Global Garlic Inc. Recalls "Queso Freso/Whole Milk Cheese" Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Global Garlic Inc., 11501 NW 107th ST, Miami, FL, is recalling its 16oz packages of “Queso Fresco/ Whole Milk” and (“Queso Fresco x LB(Barra)/Whole Milk Cheese” because they have the potential to be contaminated with Listeria monocytogenes, and 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 stillbirth among pregnant women.

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Fry’s Food Stores Issues Allergy Alert on Undeclared Pecans and Tree Nuts in Bakehouse Bread Cranberry Orange Bread - FDA Safety Alerts & Drug Recalls

Fry’s Food Stores has recalled Bakehouse Bread Cranberry Orange Bread sold in its retail stores because it contains undeclared pecans and tree nuts.

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FDA expands use of Sapien 3 artificial heart valve for high-risk patients - FDA Press Releases

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.

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Naturally Wholesome Products LLC Wholesome Country Creamery LLC Voluntary recall of Half & Half in plastic gallon and pint bottles, due to the presence of Alkaline Phosphatase in samples - FDA Safety Alerts & Drug Recalls

Naturally Wholesome Products LLC is voluntarily recalling gallon and pint containers of Half & Half labeled under the brand name Wholesome Country Creamery due to the presence of Alkaline Phosphatase found in samples during routine testing. Naturally Wholesome Products LLC has received no reports of illnesses related to the affected product and is removing the product from the market out of the abundance of caution.

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Gilster-Mary Lee Corp. Issues a Recall For Undeclared Egg Noodles in Western Family Onion Soup Mix - FDA Safety Alerts & Drug Recalls

Gilster-Mary Lee of Chester, Illinois, is voluntarily recalling one lot of Western Family Onion Soup Mix, UPC 15400-03604 because it may contain undeclared egg. 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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Influence of Hospital Type on Outcomes of Individuals Aged 80 and Older with Stroke Treated Using Intravenous Thrombolysis - American Geriatric Society

Objectives

The aim of the study was to confirm the safety and effectiveness of using intravenous thrombolysis (IVT) with individuals aged 80 and older in routine practice in different hospital settings.

Design

Observasional registry.

Setting

Prospective multicenter population-based registry of acute stroke patients treated with reperfusion therapies in Catalonia, Spain (Sistema Online d'Informació de l'Ictus Agut).

Participants

Individuals treated only with IVT (N = 3,231; 1,189 (36.8%) aged ≥80).

Measurements

Symptomatic intracranial hemorrhage, mortality, and favorable outcome (modified Rankin Scale (mRS) score = 0–2) at 3 months were evaluated according to hospital characteristics. Treating hospitals were classified in three categories: comprehensive stroke centers (CSCs), primary stroke centers (PSCs), and community hospitals operating a telestroke system (TS). First individuals aged 80 and older were compared with those younger than 80, and then participants aged 80 and older were focused on.

Results

Participants aged 80 and older had significantly higher baseline National Institute of Health Stroke Scale (NIHSS) scores, longer onset to treatment times, and worse outcomes than younger participants. For participants aged 80 and older, 90-day mortality was 23.2%, with 38.7% having favorable outcomes at 3 months. Symptomatic intracranial hemorrhage (SICH; Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy definition) was observed in 4.7% of subjects. None of the risk factors differed significantly between participants treated in different types of hospitals. Basal stroke severity measured according to NIHSS score was not significantly different either. The three different types of hospitals achieved similar outcomes, although the TS and PSC hospitals had significantly higher proportions of SICH (6.3% and 6.3%, respectively) than the CSC (3.2%).

Conclusion

Older adults with acute stroke treated with IVT had similar outcomes regardless of hospital characteristics.

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Schnucks Bakery Issues Allergy Alert on Undeclared Walnuts in Cinnamon Pudding Half Cakes and Cake Slices - FDA Safety Alerts & Drug Recalls

Cinnamon Pudding Half Cakes and Cake Slices

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Hannaford Supermarkets Issues Allergy Alert on Undeclared Milk in Taste of Inspirations Greek Pasta Salad Net. Weight 10 oz. (284g) - FDA Safety Alerts & Drug Recalls

A.S.K. Foods, Inc. of Palmyra, Pennsylvania is voluntarily recalling one lot of Hannaford Supermarkets’ TASTE OF INSPIRATIONS GREEK PASTA SALAD Net Wt. 10 oz. (284g) because it may 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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