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Adverse Drug Event

Paolo Girardi, Roberto Brugnoli, Giovanni Manfredi, Gabriele Sani
Lithium has been a gold standard in the treatment of bipolar disorder (BD) for several decades. Despite a general reduction in the use of lithium over the past several years, it is effective in the management of both manic and depressive episodes in BD and continues to be recommended as a first-line mood stabilizer. This review provides an overview of the pharmacology of lithium and highlights its clinical profile in the management of BD, focusing on the potential advantages of prolonged-release (PR) versus immediate-release (IR) formulations of lithium...
October 21, 2016: Drugs in R&D
Kathryn Schnippel, Rebecca H Berhanu, Andrew Black, Cynthia Firnhaber, Norah Maitisa, Denise Evans, Edina Sinanovic
BACKGROUND: According to the World Health Organization, South Africa ranks as one of the highest burden of TB, TB/HIV co-infection, and drug-resistant TB (DR-TB) countries. DR-TB treatment is complicated to administer and relies on the use of multiple toxic drugs, with potential for severe adverse drug reactions. We report the occurrence of adverse events (AEs) during a standardised DR-TB treatment regimen at two outpatient, decentralized, public-sector sites in Johannesburg, South Africa...
October 21, 2016: BMC Infectious Diseases
David C Classen, William Munier, Nancy Verzier, Noel Eldridge, David Hunt, Mark Metersky, Chesley Richards, Yun Wang, P Jeffrey Brady, Amy Helwig, James Battles
The explicit declaration in the landmark 1999 Institute of Medicine report "To Err Is Human" that, in the United States, 44,000 to 98,000 patients die each year as a consequence of "medical errors" gave widespread validation to the magnitude of the patient safety problem and catalyzed a number of U.S. federal government programs to measure and improve the safety of the national healthcare system. After more than 10 years, one of those federal programs, the Medicare Patient Safety Monitoring System (MPSMS), has reached a level of maturity and stability that has made it useful for the consistent measurement of the safety of inpatient care...
October 20, 2016: Journal of Patient Safety
Peter G Alexander, Karen L Clark, Rocky S Tuan
Limb congenital defects afflict approximately 0.6:1000 live births. In addition to genetic factors, prenatal exposure to drugs and environmental toxicants, represents a major contributing factor to limb defects. Examples of well-recognized limb teratogenic agents include thalidomide, warfarin, valproic acid, misoprostol, and phenytoin. While the mechanism by which these agents cause dymorphogenesis is increasingly clear, prediction of the limb teratogenicity of many thousands of as yet uncharacterized environmental factors (pollutants) remains inexact...
October 21, 2016: Birth Defects Research. Part C, Embryo Today: Reviews
Yin J Wong
Data sourcesThe Cochrane Database of Systematic Reviews on the Cochrane Library.Study selectionAll Cochrane reviews of RCTs between 1999 to 2015, conducted in adults examining the adverse events associated with single dose oral analgesics used for acute post-operative pain were considered.Data extraction and synthesisStudies were searched, reviewed and assessed independently by two reviewers and standard data items extracted. Methodological quality was assessed using criteria adapted from AMSTAR (Assessing the Methodological Quality of Systematic Reviews)...
September 2016: Evidence-based Dentistry
Ryan Eshleman, Rahul Singh
BACKGROUND: Adverse drug events (ADEs) constitute one of the leading causes of post-therapeutic death and their identification constitutes an important challenge of modern precision medicine. Unfortunately, the onset and effects of ADEs are often underreported complicating timely intervention. At over 500 million posts per day, Twitter is a commonly used social media platform. The ubiquity of day-to-day personal information exchange on Twitter makes it a promising target for data mining for ADE identification and intervention...
October 6, 2016: BMC Bioinformatics
Shuyang Yao, Xiuyi Zhi, Ruotian Wang, Kun Qian, Mu Hu, Yi Zhang
BACKGROUND: Epidermal growth factor receptor (EGFR) mutations occur in about 50% of Asian patients with non-small cell lung cancer (NSCLC). Patients with advanced NSCLC and EGFR mutations derive clinical benefit from treatment with EGFR-tyrosine kinase inhibitors (TKIs). This study assessed the efficacy and safety of adjuvant icotinib without chemotherapy in EGFR-mutated NSCLC patients undergoing resection of stage IB-IIIA. METHODS: Our retrospective study enrolled 20 patients treated with icotinib as adjuvant therapy...
September 2016: Thoracic Cancer
Matt Shirley, Lesley J Scott
Isavuconazole is a second-generation triazole with activity against a broad spectrum of clinically important fungi. Its water-soluble prodrug, isavuconazonium sulfate (Cresemba(®)), available in interchangeable intravenous and oral formulations, is approved in the USA and EU for the treatment of adults with invasive aspergillosis and mucormycosis. In international phase III clinical trials, isavuconazole was efficacious and generally well tolerated in the treatment of these life-threatening diseases. In the phase III SECURE trial, isavuconazole was non-inferior to voriconazole for the primary treatment of invasive mould disease (primarily aspergillosis) and was associated with fewer drug-related treatment-emergent adverse events (TEAEs) than voriconazole...
October 20, 2016: Drugs
Marc Jansen, Sophie Em Veldhuijzen van Zanten, Dannis G Van Vuurden, Marc Huisman, Danielle J Vugts, Otto S Hoekstra, Guus A M S van Dongen, Gert-Jan Jl Kaspers
: Predictive tools to guide therapy in children with brain tumors are urgently needed. We introduced molecular imaging to facilitate this. We investigated whether bevacizumab can reach the tumor in children with diffuse intrinsic pontine glioma (DIPG) by measuring the tumor uptake of zirconium-89((89)Zr)-labeled bevacizumab by PET. In addition we evaluated the safety of the procedure in children and determined the optimal timing of imaging. METHODS: Patients received 0...
October 20, 2016: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
S Kanda, K Goto, H Shiraishi, E Kubo, A Tanaka, H Utsumi, K Sunami, S Kitazono, H Mizugaki, H Horinouchi, Y Fujiwara, H Nokihara, N Yamamoto, H Hozumi, T Tamura
BACKGROUND: The human IgG4 monoclonal antibody nivolumab targets programmed cell death-1 (PD-1) and promotes antitumor response by blocking the interaction of PD-1 with its ligands. This single-center phase Ib study investigated the tolerability, safety, and pharmacokinetics of nivolumab combined with standard chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients who had stage IIIB without indication for definitive radiotherapy, stage IV, or recurrent NSCLC were eligible...
October 20, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Aditya H Gaur, Hilda Kizito, Wasana Prasitsueubsai, Natella Rakhmanina, Mohammed Rassool, Rana Chakraborty, Jagmohan Batra, Pope Kosalaraksa, Wicharn Luesomboon, Danielle Porter, Yongwu Shao, Michael Myers, Lillian Ting, Devi SenGupta, Erin Quirk, Martin S Rhee
BACKGROUND: The prodrug tenofovir alafenamide is associated with improved renal and bone safety compared with tenofovir disoproxil fumarate. We aimed to assess safety, pharmacokinetics, and efficacy of this single-tablet, fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-infected, treatment-naive adolescents. METHODS: We did a 48 week, single-arm, open-label trial in treatment-naive adolescents with HIV from ten hospital clinics in South Africa, Thailand, Uganda, and the USA...
October 17, 2016: Lancet HIV
Roberto Gandini, Costantino Del Giudice
OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of percutaneous catheter-delivered ultrasound energy to improve local paclitaxel delivery effects in patients with critical limb ischemia (CLI) treated for femoral-popliteal arterial disease. BACKGROUND: Treatment of patients with CLI continues to be the greatest challenge in peripheral artery disease; in particular, treatment of femoral-popliteal chronic total occlusion is characterized by poor primary patency...
October 24, 2016: JACC. Cardiovascular Interventions
Yoshio Nakamura, Shigehisa Kitano, Akira Takahashi, Arata Tsutsumida, Kenjiro Namikawa, Keiji Tanese, Takayuki Abe, Takeru Funakoshi, Noboru Yamamoto, Masayuki Amagai, Naoya Yamazaki
BACKGROUND: An anti-programmed cell death protein 1 monoclonal antibody, nivolumab, is one of the most effective drugs for advanced melanoma. Tumor cell-derived or immune cell-derived markers and clinical predictors such as serum lactate dehydrogenase (LDH) and cutaneous adverse events, have already been described as prognostic factors for advanced melanoma treated with nivolumab. We sought to identify further clinical predictors that can be determined in routine clinical practice. METHODS: We retrospectively analyzed clinical findings of 98 consecutive patients with unresectable stage III or IV melanoma treated with nivolumab, at the National Cancer Center Hospital or at Keio University Hospital, in Tokyo, Japan, between July 2014 and July 2016...
October 15, 2016: Oncotarget
Abdunoor M Kabanywanyi, Rita Baiden, Ali M Ali, Muhidin K Mahende, Bernhards R Ogutu, Abraham Oduro, Halidou Tinto, Margaret Gyapong, Ali Sie, Esperanca Sevene, Eusebio Macete, Seth Owusu-Agyei, Alex Adjei, Guillaume Compaoré, Innocent Valea, Isaac Osei, Abena Yawson, Martin Adjuik, Raymond Akparibo, Mwaka A Kakolwa, Salim Abdulla, Fred Binka
The antimalarial drug piperaquine is associated with delayed ventricular depolarization, causing prolonged QT interval (time taken for ventricular de-polarisation and re-polarisation). There is a lack of safety data regarding dihydroartemisinin/piperaquine (DHA/PPQ) for the treatment of uncomplicated malaria, which has limited its use. We created a platform where electrocardiograms (ECG) were performed in public hospitals for the safety assessment of DHA/PPQ, at baseline before the use of dihydroartemisinin/piperaquine (Eurartesim®), and on day 3 (before and after administration of the final dose) and day 7 post-administration...
2016: PloS One
J L NDiaye, B Cissé, E H Ba, J F Gomis, C T Ndour, J F Molez, F B Fall, C Sokhna, B Faye, E Kouevijdin, F K Niane, M Cairns, J F Trape, C Rogier, O Gaye, B M Greenwood, P J M Milligan
BACKGROUND: It is recommended that children aged 3 months to five years of age living in areas of seasonal transmission in the sub-Sahel should receive Seasonal Malaria Chemoprevention (SMC) with sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) during the malaria transmission season. The purpose of this study was to evaluate the safety of SMC with SPAQ in children when delivered by community health workers in three districts in Senegal where SMC was introduced over three years, in children from 3 months of age to five years of age in the first year, then in children up to 10 years of age...
2016: PloS One
Masahiro Ohgami, Masato Homma, Yoshiharu Suzuki, Kanako Naito, Motoko Yamada, Shoichi Mitsuhashi, Fumie Fujisawa, Hiroshi Kojima, Takayuki Kaburagi, Keiko Uchiumi, Yutaka Yamada, Hiroko Bando, Hisato Hara, Keiji Takei
BACKGROUND: Lapatinib and erlotinib are used for cancer treatment, showing large interindividual variability. Therapeutic drug monitoring may be useful for assessing the clinical outcomes and adverse events. A simple high-performance liquid chromatography ultraviolet method was developed for the determination of lapatinib and erlotinib in human plasma. METHODS: An aliquot of plasma sample spiked with IS was treated with acetonitrile to precipitate the proteins. Lapatinib and erlotinib were separated on an octadecylsilyl silica-gel column using a mobile phase consisting of acetonitrile, methanol, water, and trifluoroacetic acid (26:26:48:0...
October 17, 2016: Therapeutic Drug Monitoring
Lawrence C Ku, Huali Wu, Rachel G Greenberg, Kevin D Hill, Daniel Gonzalez, Christoph P Hornik, Alysha Berezny, Jeffrey T Guptill, Wenlei Jiang, Nan Zheng, Michael Cohen-Wolkowiez, Chiara Melloni
BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic drug monitoring and electronic health record (EHR) data with pharmacokinetic (PK) modeling. This approach was first tested on phenytoin, which has a known TI, and then applied to lamotrigine, which lacks a defined TI. METHODS: Retrospective EHR data from patients in a tertiary hospital were used to develop phenytoin and lamotrigine population PK models and to identify adverse events (anemia, thrombocytopenia, and leukopenia) and efficacy outcomes (seizure-free)...
October 19, 2016: Therapeutic Drug Monitoring
Lauren E Arthur, Russell S Kizor, Adrian G Selim, Mieke L van Driel, Leonardo Seoane
BACKGROUND: Ventilator-associated pneumonia (VAP) is a significant cause of morbidity and mortality, complicating the medical course of approximately 10% of mechanically-ventilated patients, with an estimated attributable mortality of 13%. To treat VAP empirically, the American Thoracic Society currently recommends antibiotic therapy based on the patients' risk of colonisation by an organism with multidrug resistance. The selection of initial antibiotic therapy in VAP is important, as inappropriate initial antimicrobial treatment is associated with higher mortality and longer hospital stay in intensive care unit (ICU) patients...
October 20, 2016: Cochrane Database of Systematic Reviews
H S Rehan, M Andley, P Nagar, V Maharshi
A 29 year male, with an inoperable adenocarcinoma of gall bladder was initiated on gemcitabine and a platinum compound based chemotherapy. During 4th cycle of chemotherapy, patient complained of chest pain following cisplatin and gemcitabine infusion. ECG was suggestive of acute coronary syndrome, which was successfully managed by antianginal therapy. Fifth cycle of chemotherapy was uneventful. Patient died of cardiovascular collapse before receiving the 6th cycle of chemotherapy. As per Naranjo adverse drug reaction probability scale, causal association of the event with cisplatin and gemcitabine was probable and possible respectively...
September 2016: Journal of the Association of Physicians of India
Omesh Goyal, Sandeep Singh Sidhu, Natasha Sehgal, Sandeep Puri
OBJECTIVES: Hepatorenal syndrome (HRS) is a functional renal failure occurring in end stage liver disease, which is associated with poor prognosis. Terlipressin has been shown to be effective in treatment of HRS. More recently, it was suggested that noradrenaline, an alpha-adrenergic drug may be also effective in HRS. We aimed to compare the efficacy of noradrenaline versus terlipressin in treatment of HRS type 1. METHODS: Consecutive patients with cirrhosis and HRS type 1 were enrolled and randomised into 2 groups- Group A received intravenous noradrenaline infusion (0...
September 2016: Journal of the Association of Physicians of India
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