Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma - FDA Press Releases

Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma

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Mid Valley Pharmaceutical LLC Issues Voluntary Recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup Due to Potential Contamination with Burkholderia Cepacia. - FDA Safety Alerts & Drug Recalls

Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.

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Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient - FDA Safety Alerts & Drug Recalls

Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.

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Dedinas Franzak Enterprises Issues Allergy Alert On Undeclared Milk In "Butter Flavored Popcorn" - FDA Safety Alerts & Drug Recalls

Dedinas Franzak Enterprises of Grand Rapids, MI, is recalling several brands of butter flavored popcorn because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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Rajbhog Distributors GA Inc. Issues Allergy Alert on Undeclared Almonds in JALEBI - FDA Safety Alerts & Drug Recalls

Rajbhog Distributors GA. Inc. of Tucker GA-30084 is recalling 1467 packets of Jalebi because it may contain undeclared Almond pcs. People who have an allergy or severe sensitivity to Almonds run the risk of serious or life- threatening allergic reaction if they consume these products.

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FDA approval brings first gene therapy to the United States - FDA Press Releases

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

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Aging Research: Collaborations Forge a Promising Future - American Geriatric Society

The National Institute on Aging (NIA), one of 27 institutes and centers at the National Institutes of Health (NIH), was founded in 1974 to conduct and support research on aging and the health and well-being of older people. The Institute's interests span the fundamental processes that contribute to aging and their impact on systems; diseases and conditions for which aging is a risk factor; and interventions that may prevent, delay, or treat these conditions or otherwise contribute to an extension of healthy, active years of life. Multiple fruitful research collaborations within and outside the federal government, spanning the breadth of the Institute's research activities, have marked NIA's growth over the past 40 years, as well as its current areas of ongoing research. This article discusses several highlights of these collaborations, including the Health and Retirement Study, geroscience research, falls injury prevention in elderly adults, and implementation of the National Plan to Address Alzheimer's Disease, from the perspective of past accomplishments and trends for the future.

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High Symptom Burden and Low Functional Status in the Setting of Multimorbidity - American Geriatric Society

Objectives

To enhance understanding of the relationship between multimorbidity, symptom burden, and functional status in individuals with life-limiting illness.

Design

Secondary analysis of baseline data from a randomized clinical trial conducted in the Palliative Care Research Cooperative Group. Group differences were tested using a t-test; multivariate regression analysis was used to determine the effect of multiple variables on functional status and symptom burden.

Setting

Fifteen Palliative Care Research Cooperation sites.

Participants

Adults who participated in a parent statin-discontinuation clinical trial were included in the analysis (N = 381). Inclusion criteria were diagnosis of a life-limiting illness, statin use for 3 months or longer, life expectancy longer than 1 month, and declining functional status.

Measurements

Cancer diagnosis (solid organ and hematologic malignancies), multimorbidity (Charlson Comorbidity Index (CCI) score), symptom burden (Edmonton Symptom Assessment Scale (ESAS) score, number of symptoms with ESAS severity score >4), functional status (Australia-modified Karnofsky Performance Scale (AKPS)).

Results

Fifty-one percent had a primary diagnosis of cancer; mean age 74.1 ± 11.6. Participants had multiple comorbid illnesses (CCI score 4.9 ± 2.8), multiple symptoms (ESAS score 27.2 ± 15.9), and poor functional status (AKPS = 53 ± 13). In univariate and multivariate analyses, multimorbidity was associated with greater symptom burden (4.2 vs 3.1 moderate or severe symptoms (t = −3.2, P = .002), 12% vs 6% with severe symptoms (t = −3.7, P < .001)), but cancer diagnosis was not. In univariate and multivariate analyses, higher symptom burden was associated with poorer functional status (F = 11.6, P < .001), but multimorbidity was not.

Conclusion

Symptoms cannot be attributed solely to a diagnosis of cancer. The association between symptom burden and functional status underscores the importance of clinical attention to symptoms in individuals with multimorbidity.

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FDA approves new antibacterial drug - FDA Press Releases

The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

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FDA approves first U.S. treatment for Chagas disease - FDA Press Releases

The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.

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Dedinas-Franzak Enterprises Issues Allergy Alert On Undeclared Milk In Big Win Butter Popcorn - FDA Safety Alerts & Drug Recalls

Dedinas-Franzak Enterprises is recalling Big Win, Butter Popcorn Artificially Flavored 5 OZ, UPC #0-11822-58492-0, This product is artificially flavored and milk is not specifically called out in the Allergen Statement. The product may contain milk and people who have an allergy or severe sensitivity to Milk may run the risk of serious or life-threatening allergic reaction if they consume this product. The concern was identified through a non-illness consumer complaint in relation to flavor.

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Is Alzheimer's Prevention Possible Today? - American Geriatric Society

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Development and Validation of a Geriatrics Knowledge Test to Evaluate Geriatrics Fellowship Programs - American Geriatric Society

Background/Objectives

Although the Accreditation Council for Graduate Medical Education requires that geriatrics fellowship programs be evaluated, evaluation is challenging because of lack of appropriate instruments. The purpose of this study was to develop and validate a geriatrics knowledge test appropriate for evaluation of geriatrics fellowship programs.

Design

Initial and replication cross-sectional validation studies.

Setting

Academic medical center.

Participants

Initial study: 11 postgraduate year (PGY)-2 and five PGY-3 internal medicine residents, eight incoming and eight graduating geriatrics fellows, and 11 geriatrics faculty (N = 43). Replication study: nine graduating fellows and three mid-year fellow cohorts (n = 11, 8, and 9) (N = 37).

Measurements

A geriatrics knowledge test was developed consisting of 31 multiple-choice questions (MCQs) selected from a 54-item pool of MCQs that the authors created. Selection criteria included content appropriateness, item correlation with total score, item discriminatory power, and item difficulty.

Results

The instrument demonstrated high reliability (Cronbach alpha = 0.83) and known group validity. The mean percentage correct scores on the knowledge test were progressively higher with more geriatrics training (P < .001). The replication study continued to show patterns of progressive increases in score with additional training. There were no floor or ceiling effects.

Conclusion

A 31-item geriatrics knowledge test demonstrates sound reliability and validity. The findings support that it is appropriate as a tool for evaluation of geriatrics fellowship programs.

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Do Safety Culture Scores in Nursing Homes Depend on Job Role and Ownership? Results from a National Survey - American Geriatric Society

Objectives

To identify facility- and individual-level predictors of nursing home safety culture.

Design

Cross-sectional survey of individuals within facilities.

Setting

Nursing homes participating in the national Agency for Healthcare Research and Quality Safety Program for Long-Term Care: Healthcare-Associated Infections/Catheter-Associated Urinary Tract Infections Project.

Participants

Responding nursing home staff (N = 14,177) from 170 (81%) of 210 participating facilities.

Measurements

Staff responses to the Nursing Home Survey on Patient Safety Culture (NHSOPS), focused on five domains (teamwork, training and skills, communication openness, supervisor expectations, organizational learning) and individual respondent characteristics (occupation, tenure, hours worked), were merged with data on facility characteristics (from the Certification and Survey Provider Enhanced Reporting): ownership, chain membership, percentage residents on Medicare, bed size. Data were analyzed using multivariate hierarchical models.

Results

Nursing assistants rated all domains worse than administrators did (P < .001), with the largest differences for communication openness (24.3 points), teamwork (17.4 points), and supervisor expectations (16.1 points). Clinical staff rated all domains worse than administrators. Nonprofit ownership was associated with worse training and skills (by 6.0 points, P =.04) and communication openness (7.3 points, P =.004), and nonprofit and chain ownership were associated with worse supervisor expectations (5.2 points, P =.001 and 3.2 points, P =.03, respectively) and organizational learning (5.6 points, P =.009 and 4.2 points, P = .03). The percentage of variation in safety culture attributable to facility characteristics was less than 22%, with ownership having the strongest effect.

Conclusion

Perceptions of safety culture vary widely among nursing home staff, with administrators consistently perceiving better safety culture than clinical staff who spend more time with residents. Reporting safety culture scores according to occupation may be more important than facility-level scores alone to describe and assess barriers, facilitators, and changes in safety culture.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine - FDA Press Releases

One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair strategies is a tangible reality. This promise is reinforced by the strong commitment of the investment and scientific communities in exploring the potential applications across a wide range of vexing diseases and conditions, such as cancer, Parkinson’s disease, and diabetes, among many others.

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FDA warns US Stem Cell Clinic of significant deviations - FDA Press Releases

The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.

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FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients - FDA Press Releases

The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.

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Trichopeptides A and B, trichocyclodipeptides A–C, new peptides from the ascomycete fungus Stagonospora trichophoricola - Journal of Antibiotics

Trichopeptides A and B, trichocyclodipeptides A–C, new peptides from the ascomycete fungus Stagonospora trichophoricola

The Journal of Antibiotics 70, 923 (August 2017). doi:10.1038/ja.2017.76

Authors: Zhengkun Chen, Xiuli Xu, Jinwei Ren, Wenzhao Wang, Xingzhong Liu & Erwei Li

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Allantopyrone A interferes with multiple components of the TNF receptor 1 complex and blocks RIP1 modifications in the TNF-α-induced signaling pathway - Journal of Antibiotics

Allantopyrone A interferes with multiple components of the TNF receptor 1 complex and blocks RIP1 modifications in the TNF-α-induced signaling pathway

The Journal of Antibiotics 70, 929 (August 2017). doi:10.1038/ja.2017.74

Authors: Hue Tu Quach, Riho Tanigaki, Junpei Yokoigawa, Yuriko Yamada, Masamitsu Niwa, Seiya Hirano, Yoshihito Shiono, Ken-ichi Kimura & Takao Kataoka

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The salicylidene acylhydrazide INP0341 attenuates Pseudomonas aeruginosa virulence in vitro and in vivo - Journal of Antibiotics

The salicylidene acylhydrazide INP0341 attenuates Pseudomonas aeruginosa virulence in vitro and in vivo

The Journal of Antibiotics 70, 937 (August 2017). doi:10.1038/ja.2017.64

Authors: Pia Uusitalo, Ulrik Hägglund, Elin Rhöös, Henrik Scherman Norberg, Mikael Elofsson & Charlotta Sundin

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Insight into synergetic mechanisms of tetracycline and the selective serotonin reuptake inhibitor, sertraline, in a tetracycline-resistant strain of Escherichia coli - Journal of Antibiotics

Insight into synergetic mechanisms of tetracycline and the selective serotonin reuptake inhibitor, sertraline, in a tetracycline-resistant strain of Escherichia coli

The Journal of Antibiotics 70, 944 (August 2017). doi:10.1038/ja.2017.78

Authors: Lili Li, Sofie Kromann, John Elmerdahl Olsen, Søren Wedel Svenningsen & Rikke Heidemann Olsen

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Coumarin–benzimidazole hybrids as a potent antimicrobial agent: synthesis and biological elevation - Journal of Antibiotics

Coumarin–benzimidazole hybrids as a potent antimicrobial agent: synthesis and biological elevation

The Journal of Antibiotics 70, 954 (August 2017). doi:10.1038/ja.2017.70

Authors: L Ravithej Singh, Srinivasa Rao Avula, Sneha Raj, Akanksha Srivastava, Gopala Reddy Palnati, C K M Tripathi, Mukesh Pasupuleti & Koneni V Sashidhara

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Antimicrobial sulfonamides clear latent Kaposi sarcoma herpesvirus infection and impair MDM2–p53 complex formation - Journal of Antibiotics

Antimicrobial sulfonamides clear latent Kaposi sarcoma herpesvirus infection and impair MDM2–p53 complex formation

The Journal of Antibiotics 70, 962 (August 2017). doi:10.1038/ja.2017.67

Authors: Fabrizio Angius, Enrica Piras, Sabrina Uda, Clelia Madeddu, Roberto Serpe, Rachele Bigi, Wuguo Chen, Dirk P Dittmer, Raffaello Pompei & Angela Ingianni

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A 2,4′-linked tetrahydroxanthone dimer with protein tyrosine phosphatase 1B inhibitory activity from the Okinawan freshwater Aspergillus sp. - Journal of Antibiotics

A 2,4′-linked tetrahydroxanthone dimer with protein tyrosine phosphatase 1B inhibitory activity from the Okinawan freshwater Aspergillus sp.

The Journal of Antibiotics 70, 967 (August 2017). doi:10.1038/ja.2017.72

Authors: Henki Rotinsulu, Hiroyuki Yamazaki, Tomohito Miura, Satomi Chiba, Defny S Wewengkang, Deiske A Sumilat & Michio Namikoshi

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NC1404, a novel derivative of Bleomycin with modified sugar moiety obtained during the preparation of Boningmycin - Journal of Antibiotics

NC1404, a novel derivative of Bleomycin with modified sugar moiety obtained during the preparation of Boningmycin

The Journal of Antibiotics 70, 970 (August 2017). doi:10.1038/ja.2017.63

Authors: Xin Qi, Xinwei Wang, Hao Ren, Feng Zhang, Xiumin Zhang, Ning He, Wenqiang Guo, Ruxian Chen, Yunying Xie & Qiyang He

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Effect of the meropenem MIC on the killing activity of meropenem and polymyxin B in combination against KPC-producing Klebsiella pneumoniae - Journal of Antibiotics

Effect of the meropenem MIC on the killing activity of meropenem and polymyxin B in combination against KPC-producing Klebsiella pneumoniae

The Journal of Antibiotics 70, 974 (August 2017). doi:10.1038/ja.2017.73

Authors: Brandon Kulengowski, Jeffrey J Campion, David J Feola & David S Burgess

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Corrigendum: γ-Ionylidene-type sesquiterpenoids possessing antimicrobial activity against Porphyromonas gingivalis from Phellinus linteus and their absolute structure determination - Journal of Antibiotics

Corrigendum: γ-Ionylidene-type sesquiterpenoids possessing antimicrobial activity against Porphyromonas gingivalis from Phellinus linteus and their absolute structure determination

The Journal of Antibiotics 70, 979 (August 2017). doi:10.1038/ja.2017.71

Authors: Tatsuya Shirahata, Chieko Ino, Fumi Mizuno, Yoshihisa Asada, Masao Hirotani, George A Petersson, Satoshi Ōmura, Takafumi Yoshikawa & Yoshinori Kobayashi

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty - FDA Press Releases

As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation’s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels.

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Cook Medical Issues Recall Correction of Zenith Alpha™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market - FDA Safety Alerts & Drug Recalls

Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase.

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Recall of Certain Frozen Organic Dark Sweet Pitted Cherry Products Due to Possible Contamination by Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Out of an abundance of caution, SunOpta Inc’s subsidiary, Sunrise Growers Inc., has issued a voluntary recall of certain frozen organic dark sweet pitted cherry products due to 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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Centurion Labs Issues Voluntary Nationwide Recall of Ninjacof (Lot # 200N1601) and Ninjacof A (Lot# 201NA1601) Products Due to Potential Burkholderia Cepacia Contamination - FDA Safety Alerts & Drug Recalls

Centurion Labs is voluntarily recalling, as a precautionary measure, 1 lot of Ninjacof (Lot# 200N1601) and 1 lot of Ninjacof A (Lot# 201NA1601) manufactured by Vilvet (Dania Beach, FL) and distributed by Centurion Labs to the retail level due to potential contamination with Burkholderia cepacia. Centurion was notified by the FDA regarding the potential contamination as they discovered this product may have been manufactured in a Pharmatech, FDA registered facility, in Davie, FL. that was found to have a product that contained B. cepacia.

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Zika virus infects renal proximal tubular epithelial cells with prolonged persistency and cytopathic effects

Zika virus infects renal proximal tubular epithelial cells with prolonged persistency and cytopathic effects

Emerging Microbes & Infections 6, e77 (August 2017). doi:10.1038/emi.2017.67

Authors: Jian Chen, Yi-feng Yang, Jun Chen, Xiaohui Zhou, Zhaoguang Dong, Tianyue Chen, Yu Yang, Peng Zou, Biao Jiang, Yunwen Hu, Lu Lu, Xiaoyan Zhang, Jia Liu, Jianqing Xu & Tongyu Zhu

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Origin and invasion of the emerging infectious pathogen Sphaerothecum destruens

Origin and invasion of the emerging infectious pathogen Sphaerothecum destruens

Emerging Microbes & Infections 6, e76 (August 2017). doi:10.1038/emi.2017.64

Authors: Salma Sana, Emilie A Hardouin, Rodolphe E Gozlan, Didem Ercan, Ali Serhan Tarkan, Tiantian Zhang & Demetra Andreou

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Red blood cells release microparticles containing human argonaute 2 and miRNAs to target genes of Plasmodium falciparum

Red blood cells release microparticles containing human argonaute 2 and miRNAs to target genes of Plasmodium falciparum

Emerging Microbes & Infections 6, e75 (August 2017). doi:10.1038/emi.2017.63

Authors: Zhensheng Wang, Juemin Xi, Xiao Hao, Weiwei Deng, Juan Liu, Chunyan Wei, Yuhui Gao, Lianhui Zhang & Heng Wang

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Identification of a natural recombinant transmissible gastroenteritis virus between Purdue and Miller clusters in China

Identification of a natural recombinant transmissible gastroenteritis virus between Purdue and Miller clusters in China

Emerging Microbes & Infections 6, e74 (August 2017). doi:10.1038/emi.2017.62

Authors: Xin Zhang, Yunnuan Zhu, Xiangdong Zhu, Hongyan Shi, Jianfei Chen, Da Shi, Jing Yuan, Liyan Cao, Jianbo Liu, Hui Dong, Zhaoyang Jing, Jialin Zhang, Xiaobo Wang & Li Feng

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Tuberculosis/cryptococcosis co-infection in China between 1965 and 2016

Tuberculosis/cryptococcosis co-infection in China between 1965 and 2016

Emerging Microbes & Infections 6, e73 (August 2017). doi:10.1038/emi.2017.61

Authors: Wenjie Fang, Lei Zhang, Jia Liu, David W Denning, Ferry Hagen, Weiwei Jiang, Nan Hong, Shuwen Deng, Xia Lei, Danqi Deng, Wanqing Liao, Jianping Xu, Teun Boekhout, Min Chen & Weihua Pan

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Chronic Obstructive Pulmonary Disease in Elderly Patients - Geriatrics

Chronic obstructive pulmonary disease (COPD) is prevalent in the elderly population, with high impact on quality of life, morbidity, and mortality. The diagnosis is usually made based on symptoms and spirometry values that support the presence of airflow obstruction. However, the condition is frequently underdiagnosed. COPD is associated with premature aging and several other medical conditions that can partially explain its underdiagnosis and management. There are several pharmacologic and nonpharmacologic interventions proven to be effective in ameliorating the symptoms of COPD. Appropriate drug delivery and reduction of side effects is also pivotal in the management of patients with COPD.

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The true strength of our healthcare system is its people - CMS Blog

By Seema Verma, Administrator for the Centers for Medicare & Medicaid Services

As a wife and mother, my family’s health is always foremost on my mind. That is why a recent personal experience will forever shape the impact I want to have while serving as Administrator of the Centers for Medicare and Medicaid Services.

Earlier this month, while at an airport with our two children, my husband collapsed and went into cardiac arrest. He’s home now and his prognosis is excellent. However, if it weren’t for the courageous bystanders who administered CPR and the dedicated medical professionals at the Hospital of the University of Pennsylvania where he was admitted, he wouldn’t be with us today.

I wasn’t at the airport when my husband collapsed. I arrived at the hospital as soon as I could, and as I met the team of professionals who were caring for him, I was amazed by their skill and compassion. From the hospital administrators to the physicians, nurses, and many others who took charge of his care, I witnessed the true greatness of our healthcare system: the remarkable people who serve within it.

My life would be very different if it weren’t for the diligence and expertise of the first responders at the airport and the healthcare professionals at the hospital. Even in our age of advanced technology, procedures, and therapies, it’s the people that make our healthcare system one that we feel we can entrust with the care of our loved ones.

My husband is a physician, and I have many relatives and close friends who are healthcare professionals as well.  To a person these caregivers are some of the smartest and most selfless people I know. They have put in long hours and made many sacrifices along the path of medical education and training. What motivates them isn’t a promise of high salaries, or a quest for esteem, but a genuine drive to help patients and their families when they are most vulnerable.

Our healthcare system is made up of a community of professionals who want to do good.  As a wife and a mother I am so grateful for this, because these professionals saved my husband and my children’s father. As the Administrator of CMS, I am inspired by this and feel compelled to do everything I can to support these caregivers. Our agency must make it easier for them to focus on doing the work that patients and families need them to do without causing them to be subject to excessive regulatory and administrative burden.

That’s why in all of our recent proposed rules, CMS has asked healthcare providers for their thoughts on how to simplify our regulations. And over the next few months we will be announcing additional initiatives to ease the burden our government places on healthcare providers. We will continue to engage with our providers on their concerns.

Some regulations are necessary in order to ensure patient safety and well-being, and to protect the integrity of federal health care programs.  However, over the past few years, regulations have tilted more towards creating burdens than towards serving as a safeguard for the programs.  This shift is now having a negative impact on patient care, hindering innovation, and increasing healthcare costs.

To make sure we are addressing the actual pain points that doctors feel, we are visiting them where they work, listening to their stories about the challenges they face, and bringing those lessons back to CMS. We have heard time and again that documentation for payment and for quality reporting is unnecessarily time-consuming and keeps clinicians working late into the night just to keep up on paperwork. Electronic health records that were supposed to make providers’ lives easier by freeing up more time to spend on patient care have distanced them from their patients. New payment structures that were meant to increase coordination have added yet another layer of rules and requirements.

No one went into medicine to become a paperwork expert. We are listening, integrating the feedback we hear into our work at CMS, and making changes that will make it easier for doctors, nurses, and other clinicians to do what they entered medicine to do: take care of those in need.

It can be easy to forget how important our healthcare system is, to forget that every day, men and women are hard at work treating, comforting, and healing. For those of us whose families have received lifesaving care, we are forever grateful. The entire CMS team and I are committed to doing our part to make sure that these caring professionals can do their job without the burden of unnecessary regulation.

Filed under: Uncategorized

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Reply to Comment on: QOL, Perceptions, and Health Satisfaction of Older Adults with End Stage Renal Disease - American Geriatric Society

This letter comments on the Letter by Nancy G. Kutner

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Comment on: Quality of Life, Perceptions, and Health Satisfaction of Older Adults with End-Stage Renal Disease - American Geriatric Society

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Function But Not Multimorbidity at The Cornerstone of Geriatric Medicine - American Geriatric Society

See the Reply by Debora Rizzuto et al.

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Reply to: Function but not Multimorbidity at the Cornerstone of Geriatric Medicine - American Geriatric Society

This letter comments on the Letter by Pedro Abizanda et al.

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Vitamin D-mentia: Is Vitamin D Optional or Essential for Preventing Late-Life Cognitive Decline? - American Geriatric Society

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Reliability of an Online Geriatric Assessment Procedure Using the interRAI Acute Care Assessment System - American Geriatric Society

Objectives

To determine whether geriatric triage decisions made using a comprehensive geriatric assessment (CGA) performed online are less reliable than face-to-face (FTF) decisions.

Design

Multisite noninferiority prospective cohort study. Two specialist geriatricians assessed individuals sequentially referred for an acute care geriatric consultation. Participants were allocated to one FTF assessment and an additional assessment (FTF or online (OL)), creating two groups—two FTF (FTF-FTF, n = 81) or online and FTF (OL-FTF, n = 85).

Setting

Three acute care public hospitals in two Australian states.

Participants

Admitted individuals referred for CGA.

Intervention

Nurse-administered CGA, based on the interRAI Acute Care assessment system accessed online and other online clinical data such as pathology results and imaging enabling geriatricians to review participants’ information and provide input into their care from a distance.

Measurements

The primary decision subjected to this analysis was referral for permanent residential care. Geriatricians also recorded recommendations for referrals and variations for medication management and judgment regarding prognosis at discharge and after 3 months.

Results

Overall percentage agreement was 88% (n = 71) for the FTF-FTF group and 91% (n = 77) for the OL-FTF group. The difference in agreement between the FTF-FTF and OL-FTF groups was −3%, indicating that there was no difference between the methods of assessment. Judgements made regarding diagnoses of geriatric syndromes, medication management, and prognosis (with regard to hospital outcome and location at 3 months) were found to be equally reliable in each mode of consultation.

Conclusion

Geriatric assessment performed online using a nurse-administered structured CGA system was no less reliable than conventional assessment in making clinical triage decisions.

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Effect of New Oral Anticoagulants on Prescribing Practices for Atrial Fibrillation in Older Adults - American Geriatric Society

Objectives

To determine the effect of new oral anticoagulants (NOACs) on prescribing practices in older adults with atrial fibrillation (AF).

Design

Retrospective observational cohort study.

Setting

Academic medical center in St. Louis, Missouri.

Participants

Individuals aged 75 and older with AF admitted to the hospital from October 2010 through September 2015 (N = 6,568, 50% female, 15% non-white).

Measurements

Information on NOACs and warfarin prescribed at discharge was obtained from hospital discharge summaries, and linear regression was used to examine quarterly trends in their use. Multivariable logistic regression was used to assess independent predictors of anticoagulant use.

Results

NOAC use increased over time (correlation coefficient (r) = 0.87, P < .001), warfarin use did not change (r = −0.16, P = .50), and overall anticoagulant use (NOACs and warfarin) increased (r = 0.68, P = .001). NOAC use increased over time in all age groups (75–79, 80–84, 85–89) except aged 90 and older, but increasing age attenuated the rate of NOAC uptake. There was no consistent relationship between age and warfarin or overall anticoagulant use, except that individuals aged 90 and older had consistently lower use. Overall, fewer than 45% of participants were prescribed an anticoagulant. In multivariable analysis, younger age, white race, female sex, higher hemoglobin, higher creatinine clearance, being on a medical service, hypertension, stroke or transient ischemic attack, no history of intracranial hemorrhage, and a modified HAS-BLED score of less than 3 increased the likelihood of receiving NOACs.

Conclusion

Prescription of anticoagulants for AF increased in older adults primarily because of an increase in the use of NOACs. Nonetheless, fewer than 45% of participants were prescribed an anticoagulant. Additional research is needed to optimize prescribing practices for older adults with AF.

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Thoracic Kyphosis and Physical Function: The Framingham Study - American Geriatric Society

Objective

To evaluate the association between thoracic kyphosis and physical function.

Design

Prospective cohort.

Setting

Framingham, Massachusetts.

Participants

Framingham Heart Study Offspring and Third Generation cohort members who had computed tomography (CT) performed between 2002 and 2005 and physical function assessed a mean 3.4 years later (N = 1,100; mean age 61 ± 8, range 50–85).

Measurements

Thoracic kyphosis (Cobb angle, T4-T12) was measured in degrees using supine CT scout images. Participants were categorized according to Cobb angle to compare those in the highest quartile (Q4, most-severe kyphosis) with those in the lowest quartiles (Q1-Q3). Quick walking speed (m/s), chair-stand time (seconds), grip strength (kg), and self-reported impairments were assessed using standardized procedures. Analyses were adjusted for age, height, weight, smoking, follow-up time, vertebral fractures, and prevalent spinal degeneration.

Results

Thoracic kyphosis was not associated with physical function in women or men, and these results were consistent in those younger than 65 and those aged 65 and older. For example, walking speed was similar in adults younger than 65 with and without severe kyphosis (women, Q4: 1.38 m/s, Q1-Q3: 1.40 m/s, P = .69; men, Q4: 1.65 m/s, Q1-Q3: 1.60 m/s; P = .39).

Conclusion

In healthy relatively high-functioning women and men, kyphosis severity was not associated with subsequent physical function. Individuals at risk of functional decline cannot be targeted based on supine CT thoracic curvature measures alone.

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Innovation in a Learning Health Care System: Veteran-Directed Home- and Community-Based Services - American Geriatric Society

A path-breaking example of the interplay between geriatrics and learning healthcare systems is the Veterans Health Administration's (VHA's) planned roll-out of a program for providing participant-directed home- and community-based services to veterans with cognitive and functional limitations. We describe the design of a large-scale, stepped-wedge, cluster-randomized trial of the Veteran-Directed Home- and Community-Based Services (VD-HCBS) program. From March 2017 through December 2019, up to 77 Veterans Affairs Medical Centers will be randomized to times to begin offering VD-HCBS to veterans at risk of nursing home placement. Services will be provided to community-dwelling participants with support from Aging and Disability Network Agencies. The VHA Partnered Evidence-based Policy Resource Center (PEPReC) is coordinating the evaluation, which includes collaboration from operational stakeholders from the VHA and Administration for Community Living and interdisciplinary researchers from the Center of Innovation in Long-Term Services and Supports and the Center for Health Services Research in Primary Care. For older veterans with functional limitations who are eligible for VD-HCBS, we will evaluate health outcomes (hospitalizations, emergency department visits, nursing home admissions, days at home) and healthcare costs associated with VD-HCBS availability. Learning healthcare systems facilitate diffusion of innovation while enabling rigorous evaluation of effects on patient outcomes. The VHA's randomized rollout of VD-HCBS to veterans at risk of nursing home placement is an example of how to achieve these goals simultaneously. PEPReC's experience designing an evaluation with researchers and operations stakeholders may serve as a framework for others seeking to develop rapid, rigorous, large-scale evaluations of delivery system innovations targeted to older adults.

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That's What Doctors Do, Right? - American Geriatric Society

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Reply to: Some Concerns About Diagnostic Test Accuracy for Infections - American Geriatric Society

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Some Concerns About Diagnostic Test Accuracy for Infections - American Geriatric Society

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Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluating prescription opioid medications approved to treat cough in children - FDA Press Releases

There’s perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health. There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms. Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks – especially for younger children – because they may contain opioids. Other times medication might not be necessary at all.

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Sleep in the Elderly - Geriatrics

Sleep normally changes with aging, with implications for healthy elderly individuals as well as for those with disease states. Less slow wave sleep (deep sleep) is expected, along with more awakenings, and a tendency toward earlier sleep times. Rapid eye movement sleep behavior disorder is seen primarily in elderly individuals, and it often represents the earliest sign of a chronic and progressive neurologic disease. Complaints of difficulty initiating and maintaining sleep (insomnia) become more common with aging. Irregular breathing with sleep also becomes more common, with an increased Apnea Hypopnea Index that may not always be clinically important.

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Lung Cancer in the Older Patient - Geriatrics

Cancers of the lung and bronchus are the leading cause of cancer deaths in men and women in the United States, and two-thirds of new lung cancer cases are diagnosed in patients over age 65. There are few dedicated clinical trials in the elderly, leading to both undertreatment and overtreatment biases. Even fit older adults experience age-related decline in physiologic reserve, and additional issues of polypharmacy, geriatric syndromes, and inadequate social support are not uncommon, leading to disparities in treatment and survival. This review discusses the challenges in balancing benefits and harms in management of lung cancer in elderly patients.

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Pulmonary Vascular Diseases in the Elderly - Geriatrics

Pulmonary hypertension is a pathologic hemodynamic condition defined by a mean pulmonary arterial pressure of 25 mm Hg or greater at rest. Because of age-associated stiffening of the heart and the pulmonary vasculature and the higher prevalence in the elderly of comorbidities associated with the development of pulmonary hypertension, it is an increasingly common finding in this patient population. A right heart catheterization is necessary for the diagnosis and characterization of pulmonary hypertension. The general management is to treat the underlying conditions responsible for the development of the disorder. Pulmonary vasodilators are indicated in patients with pulmonary arterial hypertension.

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The Effects of Aging on Lung Structure and Function - Geriatrics

Growth of the segment of the population older than 65 years has led to intensified interest in understanding the biology of aging. This article is focused on age-related alterations in lung structure that produce predictable changes in physiologic function, both at rest and during exercise. Increased insight into the physiology of the healthy aging lung should ultimately lead to improved methods of lung function assessment in the elderly (defined as those older than 65 years) as well as better understanding of the manifestations and possibly even the treatment of geriatric lung disease.

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Lung Diseases of the Elderly - Geriatrics

Natural lung aging is characterized by molecular and cellular changes in multiple lung cell populations. These changes include shorter telomeres, increased expression of cellular senescence markers, increased DNA damage, oxidative stress, apoptosis, and stem cell exhaustion. Aging, combined with the loss of protective repair processes, correlates with the development and incidence of chronic respiratory diseases, including idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease. Ultimately, it is the interplay of age-related changes in biology and the subsequent responses to environmental exposures that largely define the physiology and clinical course of the aging lung.

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Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

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Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. The compounded injectable prescription medications have been found to lack sterility assurance. Atlantic Pharmacy and Compounding became aware of this issue during an FDA (Food and Drug Administration) inspection of the pharmacy.

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Systematic Review of Sex-Specific Reporting of Data: Cholinesterase Inhibitor Example - American Geriatric Society

Objectives

To improve the value of research for older adults, we examine sex-specific reporting of data from drug trials for the management of dementia. These data are important because they may influence considerations ranging from the health of populations to shared decision-making by individual patient and caregiver about the risk and benefit of a drug therapy.

Methods

Randomized controlled trials of cholinesterase inhibitors (i.e., donepezil, rivastigmine, or galantamine) with clinical outcomes were identified from searches of MEDLINE, EMBASE, and the Cochrane Library. Sex-specific data were extracted from nine sections (title, abstract, introduction, methods, outcomes, results, discussion, limitations, and conclusion). Among the donepezil trials only, more detailed harms data were obtained.

Findings

Thirty-three randomized controlled trials were identified evaluating 15,971 participants (9,103 (57%) female). Trials were highly cited (median citations 158, interquartile range 62–441) and published in high impact journals (median impact factor 7.4, interquartile range 3.4–8.2). Sex was not mentioned in the title, introduction, limitations, or conclusion section of any trial. Only three trials (9%) mentioned sex in the abstract (all as a demographic characteristic), and 8 (24%) in the methods. Almost all (32 (97%)) trials mentioned sex in the results as a demographic variable. One trial reported a sex difference for a secondary outcome. Among the 16 trials studying donepezil, adverse events were frequently reported and often dose-related. No trial provided sex-specific reporting of adverse events.

Conclusions

There is an almost complete lack of sex-specific reporting of data in clinical trials for dementia drug therapies, and no sex-specific reporting of adverse events. Sex-specific reporting of data should be required in drug trials to increase research value and ultimately inform more tailored prescribing for older adults.

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FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection - FDA Press Releases

As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection.

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FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia - FDA Press Releases

The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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United Trading Inc. Issues Allergy Alert on Undeclared Sulfites in “Gazab Green Raisins (Chinese)” - FDA Safety Alerts & Drug Recalls

United Trading Inc of Des Plaines, IL, is recalling its 7 ounce and 14 ounce packages of “Gazab Green Raisins (Chinese)”, because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

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Seven Sundays LLC. Recalls Vanilla Cherry Pecan Muesli Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Seven Sundays LLC of Minneapolis, MN is recalling their Vanilla Cherry Pecan Muesli 12 oz. pouches because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.

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Amneal Pharmaceuticals Issues Voluntary Nationwide Recall of Lorazepam Oral Concentrate, USP 2mg/mL, Due to Misprinted Dosing Droppers Supplied with the Product - FDA Safety Alerts & Drug Recalls

Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party.

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Grand BK Corp. Issues Allergy Alert on Undeclared Tree Nuts (Almonds, Walnuts and Cashews) in "California Aloha Mix" - FDA Safety Alerts & Drug Recalls

GRAND BK CORP. of Maspeth, New York is recalling its 14 ounce packages of "CALIFORNIA ALOHA MIX" because they may contain undeclared tree nuts (Almonds, Walnuts and Cashews). People who have allergies or severe sensitivity to tree nuts (Almonds, Walnuts and Cashews) run the risk of serious or life-threatening allergic reaction if they consume these products.

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Dierbergs Markets Issues Allergy Alert on Undeclared Fish (Bonito and Cod), Lobster, Crab, Shrimp, Soy and Wheat in Product - FDA Safety Alerts & Drug Recalls

St Louis-based Dierbergs Markets is recalling two Deli Products with multiple use by dates in all 25 retail stores due to the presence of undeclared fish (bonito, cod), undeclared lobster, crab, and shrimp in scampi butter and undeclared soy and wheat in cabernet grille butter. People who have allergies to fish, lobster, crab, shrimp, soy, or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

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Litehouse Inc. Issues Allergy Alert on Undeclared Egg In Product - FDA Safety Alerts & Drug Recalls

Litehouse Inc. is voluntarily recalling a limited quantity of its OPA by Litehouse Ranch because it may contain undeclared eggs. The Food and Drug Administration has been made aware of this recall which is limited to one production day from a single manufacturing location.

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Myelodysplastic Syndrome and Giant Cell Arteritis: A Nonfortuitous Association that Geriatricians Should Know About - American Geriatric Society

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Effect of the Tool to Reduce Inappropriate Medications on Medication Communication and Deprescribing - American Geriatric Society

Objectives

To examine the effect of the Tool to Reduce Inappropriate Medications (TRIM), a web tool linking an electronic health record (EHR) to a clinical decision support system, on medication communication and prescribing.

Design

Randomized clinical trial.

Setting

Primary care clinics at a Veterans Affairs Medical Center.

Participants

Veterans aged 65 and older prescribed seven or more medications randomized to receipt of TRIM or usual care (N = 128).

Intervention

TRIM extracts information on medications and chronic conditions from the EHR and contains data entry screens for information obtained from brief chart review and telephonic patient assessment. These data serve as input for automated algorithms identifying medication reconciliation discrepancies, potentially inappropriate medications (PIMs), and potentially inappropriate regimens. Clinician feedback reports summarize discrepancies and provide recommendations for deprescribing. Patient feedback reports summarize discrepancies and self-reported medication problems.

Measurements

Primary: subscales of the Patient Assessment of Care for Chronic Conditions (PACIC) related to shared decision-making; clinician and patient communication. Secondary: changes in medications.

Results

29.7% of TRIM participants and 15.6% of control participants provided the highest PACIC ratings; this difference was not significant. Adjusting for covariates and clustering of patients within clinicians, TRIM was associated with significantly more-active patient communication and facilitative clinician communication and with more medication-related communication among patients and clinicians. TRIM was significantly associated with correction of medication discrepancies but had no effect on number of medications or reduction in PIMs.

Conclusion

TRIM improved communication about medications and accuracy of documentation. Although there was no association with prescribing, the small sample size provided limited power to examine medication-related outcomes.

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Validation of a Geriatric Trauma Prognosis Calculator: A P.A.L.Li.A.T.E. Consortium Study - American Geriatric Society

Background/Objectives

The P.A.L.Li.A.T.E. (prognostic assessment of life and limitations after trauma in the elderly) consortium has previously created a prognosis calculator for mortality after geriatric injury based on age, injury severity, and transfusion requirement called the geriatric trauma outcome score (GTOS). Here, we sought to create and validate a prognosis calculator called the geriatric trauma outcome score ii (GTOS II) estimating probability of unfavorable discharge.

Design

Retrospective cohort.

Setting

Four geographically diverse Level 1 trauma centers.

Participants

Trauma admissions aged 65 to 102 years surviving to discharge from 2000 to 2013.

Intervention

None.

Measurements

Age, injury severity score (ISS), transfusion at 24 hours post-admission, discharge dichotomized as favorable (home/rehabilitation) or unfavorable (skilled nursing/long term acute care/hospice). Training and testing samples were created using the holdout method. A multiple logistic mixed model (GTOS II) was created to estimate the odds of unfavorable disposition then re-specified using the GTOS II as the sole predictor in a logistic mixed model using the testing sample.

Results

The final dataset was 16,114 subjects (unfavorable discharge status = 15.4%). Training (n = 8,057) and testing (n = 8,057) samples had similar demographics. The formula based on the training sample was (GTOS II = Age + [0.71 × ISS] + 8.79 [if transfused by 24 hours]). Misclassification rate and AUC were 15.63% and 0.67 for the training sample, respectively, and 15.85% and 0.67 for the testing sample.

Conclusion

GTOS II estimates the probability of unfavorable discharge in injured elders with moderate accuracy. With the GTOS mortality calculator, it can help in goal setting conversations after geriatric injury.

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Trends in Aging-Related Services During Nephrectomy: Implications for Surgery in an Aging Population - American Geriatric Society

Objectives

To characterize the extent to which geriatric and related healthcare services are provided to older adults undergoing surgery for kidney cancer, a potential growth area in geriatrics and oncology.

Design

Population-based observational study.

Setting

Surveillance, Epidemiology, and End Results cancer data linked with Medicare claims.

Participants

Adults aged 65 and older with kidney cancer treated surgically from 2000 to 2009 (N = 19,129).

Measurements

Receipt of geriatric consultation, medical comanagement during the surgical hospitalization, inpatient physical or occupational therapy (PT/OT), and postacute PT/OT during the surgical care episode. Multivariable, mixed-effects models were used to identify associated participant and hospital characteristics, examine trends over time, and characterize hospital-level variation.

Results

Geriatric consultation occurred rarely in the perioperative period (2.6%). Medical comanagement (15.8%), inpatient PT/OT (34.2%), and postacute PT/OT (15.6%) occurred more frequently. In our mixed-effects models, participant age and comorbidity burden appeared to be consistent determinants of use of services, although hospital-level variation was also noted (P < .001). Use of geriatric consultation increased modestly in the latter years of the study period (P < .05). In contrast, medical comanagement (183%), inpatient PT/OT (73%), and postacute PT/OT (71%) increased substantially over the study period (P < .001).

Conclusion

Although geriatric consultation remained sparse, use of medical comanagement and rehabilitation services has grown considerably for older adults undergoing surgery for kidney cancer. Efforts to reorganize cancer and surgery care should explore reasons for variation and the potential for these service elements to meet the health needs of an aging population.

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MADHAVA Natural Sweeteners Issues Allergy Alert on Undeclared Milk in its 13.8 oz. MMM... Chocolate Chip Cookie Mix - FDA Safety Alerts & Drug Recalls

Madhava Natural Sweeteners of LONGMONT, CO is recalling its 13.8 oz. box of MMM... Chocolate Chip Cookie Mix 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 this product.

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FDA warns of potential contamination in multiple brands of drugs, dietary supplements - FDA Press Releases

The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection.

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Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Due to Possible Product Contamination - FDA Safety Alerts & Drug Recalls

As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.

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International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Pravastatin Sodium Tablets USP, 40mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-925-16; Lot # 115698A - FDA Safety Alerts & Drug Recalls

International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets.

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Schnucks Bakery Issues Allergy Alert on Undeclared Pecans in German Chocolate Cake Labeled as “Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow” - FDA Safety Alerts & Drug Recalls

Schnucks Bakery, a St. Louis, Mo. establishment, is issuing an allergy alert on 13 German Chocolate Cakes labeled as “Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow” that contain pecans that are not listed on the ingredient label. Those with an allergy or severe sensitivity to pecans run the risk of a serious or life-threatening allergic reaction if they consume this product.

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Role of domestic ducks in the emergence of a new genotype of highly pathogenic H5N1 avian influenza A viruses in Bangladesh

Role of domestic ducks in the emergence of a new genotype of highly pathogenic H5N1 avian influenza A viruses in Bangladesh

Emerging Microbes & Infections 6, e72 (August 2017). doi:10.1038/emi.2017.60

Authors: Subrata Barman, Atanaska Marinova-Petkova, M Kamrul Hasan, Sharmin Akhtar, Rabeh El-Shesheny, Jasmine CM Turner, John Franks, David Walker, Jon Seiler, Kimberly Friedman, Lisa Kercher, Trushar Jeevan, Daniel Darnell, Ghazi Kayali, Lisa Jones-Engel, Pamela McKenzie, Scott Krauss, Richard J Webby, Robert G Webster & Mohammed M Feeroz

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Identification of a second encephalitis-associated astrovirus in cattle

Identification of a second encephalitis-associated astrovirus in cattle

Emerging Microbes & Infections 6, e71 (August 2017). doi:10.1038/emi.2017.56

Authors: Torsten Seuberlich, Daniel Wüthrich, Senija Selimovic-Hamza, Cord Drögemüller, Anna Oevermann, Rémy Bruggmann & Ilias Bouzalas

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Dengue burden in India: recent trends and importance of climatic parameters

Dengue burden in India: recent trends and importance of climatic parameters

Emerging Microbes & Infections 6, e70 (August 2017). doi:10.1038/emi.2017.57

Authors: Srinivasa Rao Mutheneni, Andrew P Morse, Cyril Caminade & Suryanaryana Murty Upadhyayula

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Zika virus replication in the mosquito Culex quinquefasciatus in Brazil

Zika virus replication in the mosquito Culex quinquefasciatus in Brazil

Emerging Microbes & Infections 6, e69 (August 2017). doi:10.1038/emi.2017.59

Authors: Duschinka RD Guedes, Marcelo HS Paiva, Mariana MA Donato, Priscilla P Barbosa, Larissa Krokovsky, Sura W dos S Rocha, Karina LA Saraiva, Mônica M Crespo, Tatiana MT Rezende, Gabriel L Wallau, Rosângela MR Barbosa, Cláudia MF Oliveira, Maria AV Melo-Santos, Lindomar Pena, Marli T Cordeiro, Rafael F de O Franca, André LS de Oliveira, Christina A Peixoto, Walter S Leal & Constância FJ Ayres

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Apathy: Risk Factor for Mortality in Nursing Home Patients - American Geriatric Society

Objectives

To determine the prognostic value of apathy for mortality in patients of somatic (SC) and dementia special care (DSC) nursing home (NH) units.

Design

Longitudinal design, secondary analyses of a 2-year, cluster-randomized trial with six measurements, approximately 4 months in between.

Setting

SC and DSC-units of Dutch NHs.

Participants

NH-patients of seventeen SC-units (n = 342) and sixteen DCS-units (n = 371).

Measurements

Data were available for 713 NH-patients, 266 of whom died during the study. Apathy was assessed using the 10-item Apathy Evaluation Scale (AES-10) and applied as categorical variable using known cut-off scores as well as dimensional variable. Additionally, depressive symptoms were assessed using the Cornell Scale for Depression in Dementia.

Results

Mixed effects cox models using the coxme package in R revealed a higher risk of mortality between two measurements, if apathy was present (hazard ratio (HR) = 1.77; 95% confidence interval (CI] = 1.35–2.31, P < .001). Results remained significant (HR = 1.64; 95% CI = 1.23–2.19, P < .001) when controlled for depressive symptoms. DSC-units and SC-units did not differ (P > .05) in the effect of apathy on mortality. Male gender (HR = 1.67; 95% CI = 1.23–2.27, P < .001), and higher age in years (HR = 1.06; 95% CI = 1.04–1.08, P < .001) were also predictors of mortality. Regarding apathy as a dimensional construct, one standard deviation increase of AES-10 scores was associated with a 62% increase of mortality risk (HR = 1.62, 95% CI = 1.40–1.88, P < .001).

Conclusions

Apathy was associated with mortality over a 4-month period in NH patients, even when controlling for depression. These data suggest that screening and treatment strategies for apathy should be developed for this patient population.

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Taylor Farms Retail, Inc. Recalls Coleslaw Kits Due To Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls

Taylor Farms Retail, Inc. in Salinas is conducting a limited recall of 293 cases of Taylor Farms Creamy Homestyle Coleslaw Kits due to an undeclared milk allergen. Milk is an ingredient in the dressing packet included in the salad kit. This recall is limited to one production day from a single location which distributes to Raley’s in California and Savemart in California. The recall did not apply to any other Taylor Farms products.

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The Comfy Cow Recalls Pints of Ice Cream Due To Possible E. Coli Contamination and/or High Coliform Counts - FDA Safety Alerts & Drug Recalls

The Comfy Cow is recalling pints of Banana Puddin Y’all, Chocolate Squared2, Cookies and Cream, Cow Trax, Double Fold Vanilla, Georgia Butter Pecan, Intense Dark Chocolate, Salted Caramel, Strawberry Fields Forever due to a potential contamination of E. coli. E. coli bacteria can cause diarrhea and dehydration. Most people who are infected recover, but the bacteria can be deadly.

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FDA to expand public education campaign to focus on prevention of youth e-cigarette use - FDA Press Releases

Today, the U.S. Food and Drug Administration announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids. The agency plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.

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Freshtex Produce Recalls “Valery” Brand Maradol Papayas Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Freshtex Produce of Alamo, TX is voluntarily recalling “Valery” brand Maradol Papayas grown and packed by Carica de Campeche, 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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Agroson’s LLC Recalls Maradol Papaya Cavi Brand Grown and Packed by Carica De Campeche Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Agroson’s LLC of Bronx, NY is recalling 2,483 boxes of Maradol Papaya Cavi Brand, grown and packed by Carica de Campeche, as a precaution because other brands that also buy from this farm have been tested positive for 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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Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions - FDA Press Releases

U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah, two of the company’s co-owners, William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown.

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FDA approves Mavyret for Hepatitis C - FDA Press Releases

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.

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Rugby Laboratories Issues Voluntary Nationwide Recall of Diocto Liquid and Diocto Syrup Manufactured By PharmaTech, LLC Due to Possible Product Contamination - FDA Safety Alerts & Drug Recalls

Rugby® Laboratories of Livonia, MI is voluntarily recalling all lots within the expiry of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC of Davie, FL due to a risk of product contamination with Burkholderia cepacia. If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at-risk patient population.

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Longitudinal Cognitive Profiles in Diabetes: Results From the National Alzheimer's Coordinating Center's Uniform Data - American Geriatric Society

Background

Diabetes is a risk factor for the development of cognitive impairment and possibly for accelerated progression to Alzheimer disease (AD) and other dementias, though the trajectory of cognitive decline in general and in specfic cognitive domains by diabetes is unclear.

Methods

Using the National Alzheimer's Coordinating Center's Uniform Data Det (NACC-UDS) to identify cohorts of elders with normal cognition (N = 7,663) and mild cognitive impairment (MCI, N = 4,114), we compared overall cognitive composite and domain specific sub-scores and their progression over time between diabetic and non-diabetic subjects.

Results

Diabetes was more common among those with MCI (14.7%) than among subjects who were cognitively normal (11.7%). In subjects who were cognitively normal, baseline cognitive composite scores, attention, and executive function sub-scores were lower in diabetics than non-diabetics (by 0.098, 0.066, and 0.015 points, respectively). Over time, cognitive composite score showed subtle worsening in non-diabetics (0.025 points every 6 months), with an additional worsening of 0.01 points every 6 months in diabetics compared to non-diabetics. In the MCI groups, baseline cognitive composite as well as attention and executive domain sub-scores were lower in diabetics than non-diabetics (by 0.078, 0.092, and 0.032 points, respectively). Over time, cognitive composite (by 0.103 points every 6 months) and all domain specific sub-scores showed subtle worsening in non-diabetics, but diabetics had significantly slower worsening than non-diabetics on both cognitive composite (by 0.028 points) and domain specific sub-scores.

Discussion

Among elders, diabetes may be associated with lower cognitive performance, primarily in non-memory domains. However it is not associated with continued worsening, suggesting a static deficit with minimal memory involvement. This data suggest that diabetes may contribute more to a vascular profile of cognitive impairment than a profile more typical of AD.

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FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia - FDA Press Releases

The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.

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Comorbidities of Lung Disease in the Elderly - Geriatrics

Comorbidities are common in elderly individuals with chronic respiratory diseases. They can affect disease manifestations and severity and can even impact management. Comorbidities can affect the treatment of the lung disease, particularly because of the interaction with the respiratory drugs. Thus, a multidimensional approach with multidisciplinary intervention is suggested for elderly respiratory patients, switching from a disease-oriented scheme to a dysfunction-oriented approach. Unfortunately, older individuals are often excluded from clinical trials because of advanced age and comorbidities. This article reviews the role of comorbidities in the management of respiratory diseases in the elderly.

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Amrita Health Foods Voluntarily Recalls Protein Bars For Possible Health Risk - FDA Safety Alerts & Drug Recalls

Amrita Health Foods is recalling a limited number of Amrita 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. No confirmed illnesses have been reported to public health authorities to date.

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Fairway ‘‘Like No Other Market’’ ® Recalls Fairway Brand Cookies Blondie Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Fairway ‘‘Like No Other Market’’® of New York, NY is voluntarily recalling Fairway brand Cookies Blondie, because the product may contain undeclared ingredient, walnuts. People who have an allergy or severe sensitivity to nuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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Grande Produce Issues Voluntary Recall of Limited Quantity of Papaya “Caribeña” Due to Potential Health Risk (Spanish Version) - FDA Safety Alerts & Drug Recalls

Salmonella is an organism that 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, nausea, vomiting and abdominal pain.

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Commonwealth Dairy, LLC Issues Allergy Alert On Undeclared Almond In Aldi Key Lime Crunch Tilts - FDA Safety Alerts & Drug Recalls

Commonwealth Dairy of Brattleboro, VT is recalling Friendly Farms Key Lime Crunch Tilts because it may contain undeclared almond pieces. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA approves treatment for chronic graft versus host disease - FDA Press Releases

The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.

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Prevention of Alzheimer's Disease: Lessons Learned and Applied - American Geriatric Society

Alzheimer's disease (AD) affects more than 5 million Americans, with substantial consequences for individuals with AD, families, and society in terms of morbidity, mortality, and healthcare costs. With disease-modifying treatment trials unsuccessful at the present time and only medications to treat symptoms available, an emerging approach is prevention. Advances in diagnostic criteria, biomarker development, and greater understanding of the biophysiological basis of AD make these initiatives feasible. Ongoing pharmacological trials using anti-amyloid therapies are underway in sporadic and genetic forms of AD, although a large number of modifiable risk factors for AD have been identified in observational studies, many of which do not appear to exert effects through amyloid or tau. This suggests that prevention studies focusing on risk reduction and lifestyle modification may offer additional benefits. Rather than relying solely on large-sample, long-duration, randomized clinical trial designs, a precision medicine approach using N-of-1 trials may provide more-rapid information on whether personalized prevention plans can improve person-centered outcomes. Because there appear to be multiple pathways to developing AD, there may also be multiple ways to prevent or delay the onset of AD. Even if these precision approaches alone are not successful in preventing AD, they may greatly improve the likelihood of amyloid- or tau-specific therapies to reach their endpoints by reducing comorbidities. Keeping this in mind, dementia may be a disorder that develops over a lifetime, with individualized ways to build a better brain as we age.

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The AMPT Life, LLC Issues Voluntary Nationwide Recall of AMPT Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk - FDA Safety Alerts & Drug Recalls

The AMPT Life, LLC is voluntarily recalling all lots of AMPT Coffee to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED). AMPT Coffee also contains undeclared milk.

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FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia - FDA Press Releases

The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

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