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https://www.readbyqxmd.com/read/28073851/increased-risk-of-adverse-neurocognitive-outcomes-with-proprotein-convertase-subtilisin-kexin-type-9-inhibitors
#1
Abdur Rahman Khan, Chirag Bavishi, Haris Riaz, Talha A Farid, Sobia Khan, Michel Atlas, Glenn Hirsch, Sohail Ikram, Roberto Bolli
BACKGROUND: There is encouraging evidence of the efficacy of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors; however, their long-term safety remains unclear. We performed a meta-analysis of studies to evaluate the long-term safety of PCSK9 inhibitors. METHODS AND RESULTS: Our search strategy yielded 11 studies (9 smaller early-phase and 2 larger outcome trials). The outcomes assessed were cumulative serious adverse events, musculoskeletal adverse events, neurocognitive adverse events, and stroke...
January 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28073687/adverse-event-detection-using-the-fda-post-marketing-drug-safety-surveillance-system-cardiotoxicity-associated-with-loperamide-abuse-and-misuse
#2
Kimberley A Swank, Eileen Wu, Cindy Kortepeter, Jana McAninch, Robert L Levin
OBJECTIVE: The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. METHODS: We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016...
January 7, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28060547/the-safety-of-sacubitril-valsartan-for-the-treatment-of-chronic-heart-failure
#3
Jeffrey M Tyler, John R Teerlink
Sacubitril-valsartan is a combination drug that contains the neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In 2015, the US Food and Drug Administration approved sacubitril-valsartan for treatment of heart failure patients with reduced ejection fraction and New York Heart Association class II-IV symptoms following a large, Phase III clinical trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary end-point of death from cardiovascular cause or hospitalization for heart failure compared to enalapril...
January 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28048780/tu-ab-204-00-cdrh-fda-regulatory-processes-and-device-science-activities
#4
Anita Nosratieh
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28048121/tu-ab-204-01-device-approval-process
#5
J Delfino
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28048009/tu-ab-204-03-research-activities-in-medical-physics
#6
A Badano
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047465/tu-ab-204-02-device-adverse-events-and-compliance
#7
S Gonzales
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28047346/tu-ab-204-04-partnerships
#8
R Ochs
: The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/28034354/recombinant-activated-factor-vii-eptacog-alfa-activated-novoseven-%C3%A2-in-patients-with-rare-congenital-bleeding-disorders-a-systematic-review-on-its-use-in-surgical-procedures
#9
Matteo Nicola Dario Di Minno, Pasquale Ambrosino, Veronika A Myasoedova, Manuela Amato, Itala Ventre, Elena Tremoli, Alessandro Di Minno
In the absence of definite guidelines in the area, we have carried a systemic review to provide a thorough overview concerning the efficacy and safety of recombinant activated factor VII (rFVIIa, NovoSeven®, Novo Nordisk A/S, Bagsværd, Denmark) in patients with Glanzmann's thrombasthenia (GT) and FVII deficiency, undergoing surgical procedures. PubMed, Web of Science, Scopus and EMBASE databases was employed for the search. Three multicenter registries were identified: the Glanzmann's Thrombasthenia Registry (GTR), the Seven Treatment Evaluation Registry (STER), and a German post-marketing surveillance registry (the WIRK study)...
December 30, 2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28008577/-licensing-of-pharmaceuticals-and-medical-devices-in-germany-weaknesses-and-opportunities
#10
D Reinhardt, M Wildner
The purpose of this study is to describe and compare the licensing of pharmaceuticals and medical devices in Germany. Weaknesses and opportunities of the respective processes are identified. Methods: To describe and compare the two approaches, a systematic literature review was conducted, followed by an archival analysis, guided by experts. Unstructured interviews were conducted with experts (users, financers, surveillants and producers) personally or by telephone to identify weaknesses and opportunities. The data were evaluated by content analysis according to Mayring and MAXQDA 11...
December 2016: Das Gesundheitswesen
https://www.readbyqxmd.com/read/27977317/disproportionality-analysis-of-buprenorphine-transdermal-system-and-cardiac-arrhythmia-using-fda-and-who-postmarketing-reporting-system-data
#11
Nelson E Sessler, Ekaterina Walker, Harsha Chickballapur, James Kacholakalayil, Paul M Coplan
OBJECTIVE: Positive-controlled clinical studies have shown a dose dependent effect of buprenorphine transdermal system on QTc interval prolongation. This study provides assessment of the buprenorphine transdermal system and cardiac arrhythmia using US FDA and WHO postmarketing reporting databases. METHODS: Disproportionality analysis of spontaneously reported adverse events to assess whether the reporting rate of cardiac arrhythmia events was disproportionately elevated relative to expected rates of reporting in both FDA and WHO databases...
January 2017: Postgraduate Medicine
https://www.readbyqxmd.com/read/27960593/rapid-safety-assessment-of-a-seasonal-intradermal-trivalent-influenza-vaccine
#12
Marc Demeulemeester, Nathalie Lavis, Yohan Balthazar, Patrice Lechien, Stéphane Heijmans
Seasonal influenza vaccine formulations must be updated annually to correspond to the influenza viruses in circulation. This was an uncontrolled, open-label, multi-center phase IV study conducted in Belgium to comply with interim European Medicines Agency (EMA) guidelines for rapidly evaluating the safety of newly formulated seasonal influenza vaccines. Adult volunteers received one dose of the 2014-2015 Northern Hemisphere formulation of licensed intradermal trivalent influenza vaccine at either the standard dose (9 µg hemagglutinin/strain for 18-59 year-olds) or the high dose (15 µg hemagglutinin/strain for ≥ 60 year-olds)...
December 14, 2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/27958663/effectiveness-and-safety-of-tolvaptan-in-liver-cirrhosis-patients-with-edema-interim-results-of-samsca-post-marketing-surveillance-in-liver-cirrhosis-start-study
#13
Isao Sakaida, Shuji Terai, Masayuki Kurosaki, Moriyoshi Yasuda, Mitsuru Okada, Kosuke Bando, Yasuhiko Fukuta
AIM: Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large scale post-marketing surveillance study has been performed to evaluate the effectiveness and safety of tolvaptan in real-world clinical settings. METHODS: Hepatic cirrhosis with insufficient response to conventional diuretics was enrolled...
December 13, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/27957745/exploring-new-zealand-prescription-data-using-sequence-symmetry-analyses-for-predicting-adverse-drug-reactions
#14
P S Nishtala, T-Y Chyou
WHAT IS KNOWN AND OBJECTIVE: Prescription sequence symmetry analyses (PSSA) is a ubiquitous tool employed in pharmacoepidemiological research to predict adverse drug reactions (ADRs). Several studies have reported the advantage of PSSA as a method that can be applied to a large prescription database with computational ease. The objective of this study was to validate New Zealand (NZ) prescription database as a potential source for identifying ADRs using the PSSA method. METHODS: We analysed de-identified individual-level prescription data for people aged 65 years and above for the period 2005 to 2014 from the pharmaceutical collections supplied by the NZ Ministry of Health...
December 13, 2016: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/27923380/quality-evaluation-of-commercially-available-male-condoms-in-rio-de-janeiro-brazil-2009-2011
#15
Janete Teixeira Duarte, Antonio Eugenio C C de Almeida, Shirley de Mello Pereira Abrantes
BACKGROUND: The increased incidence of sexually transmitted infections (STIs) in Brazil represents a significant public health issue. This issue has raised awareness among health authorities regarding the quality of condoms. In Brazil, male condoms need to be certified. The certification process evaluates in detail the manufacturing and quality of the final product; however, post-market surveillance is not part of the normal certification practice. METHODS: From 2009 to 2011, we evaluated 20 male condoms brands per lot of 8 manufactures-both domestic and imported-marketed in Rio de Janeiro, Brazil...
December 7, 2016: Reproductive Health
https://www.readbyqxmd.com/read/27916532/primary-total-hip-arthroplasty-in-catalonia-what-is-the-clinical-evidence-that-supports-our-prosthesis
#16
D Chaverri-Fierro, L Lobo-Escolar, M Espallargues, O Martínez-Cruz, L Domingo, M Pons-Cabrafiga
INTRODUCTION: The implementation of National Prostheses Registries allows us to obtain a large amount of data and make conclusions in order to improve the use of them. Sweden was the first country to implement a National Prostheses Registry in 1979. Catalonia has been doing this since 2005. The aim of our study is to analyse the evidence that supports primary total hip replacement in Catalonia in the last 9 years, based on the Arthroplasty Registry of Catalonia (RACat). MATERIAL AND METHODS: A review of the literature was carried out of the prosthesis (acetabular cups/stems) reported in the RACat between the period 2005 to 2013 in the following databases: ODEP (Orthopaedic Data Evaluation Panel), TRIP database, PubMed, and Google Scholar...
December 1, 2016: Revista Española de Cirugía Ortopédica y Traumatología
https://www.readbyqxmd.com/read/27890848/postmarket-clinical-experience-with-the-incraft-aaa-stent-graft-system-for-challenging-access-routes
#17
Masayuki Sugimoto, Giovanni F Torsello, Giovanni B Torsello, Martin Austermann, Arne Stachmann, Theodosios Bisdas
BACKGROUND: The INCRAFT system is a new device that has become available in Europe in September 2014 after the announcement of the 2-year results of the INNOVATION trial. However, no data in the "real-world" practice exist. Herein, we report our early series of consecutive patients treated with the INCRAFT after its launch on the market. METHODS: Prospectively collected data of patients enrolled in the INNOVATION trial (group IT) and consecutive patients from CE Mark approval to April 2015 (group CM) were retrospectively evaluated and compared...
November 25, 2016: Annals of Vascular Surgery
https://www.readbyqxmd.com/read/27888478/examining-the-quality-of-medicines-at-kenyan-healthcare-facilities-a-validation-of-an-alternative-post-market-surveillance-model-that-uses-standardized-patients
#18
Francis Wafula, Amy Dolinger, Benjamin Daniels, Njeri Mwaura, Guadalupe Bedoya, Khama Rogo, Ana Goicoechea, Jishnu Das, Bernard Olayo
BACKGROUND: Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. OBJECTIVE: The aim of this study was to validate an alternative post-market surveillance model to complement existing models. METHODS: The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition...
November 25, 2016: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/27875916/new-era-in-treatment-options-of-chronic-hepatitis-c-focus-on-safety-of-new-direct-acting-antivirals-daas
#19
Cristina Scavone, Liberata Sportiello, Concetta Rafaniello, Annamaria Mascolo, Maurizio Sessa, Francesco Rossi, Annalisa Capuano
New direct-acting antivirals have changed hepatitis C virus infection management extremely. Areas covered: The pharmacological management of HCV infection and the main characteristics of new DAA therapies have been discussed. In order to analyse safety data regarding DAA therapies, a narrative review was performed searching for safety results of main second generation DAAs pivotal and post-marketing studies. Data on main DAAs drug-drug interactions have also been discussed. Results of main DAAs pivotal studies revealed that these drugs were frequently associated to adverse events such as asthenia, headache, nausea, and insomnia...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27862608/assessing-prescription-drug-abuse-using-functional-principal-component-analysis-fpca-of-wastewater-data
#20
Stefania Salvatore, Jo Røislien, Jose A Baz-Lomba, Jørgen G Bramness
BACKGROUND: Wastewater-based epidemiology is an alternative method for estimating the collective drug use in a community. We applied functional data analysis, a statistical framework developed for analysing curve data, to investigate weekly temporal patterns in wastewater measurements of three prescription drugs with known abuse potential: methadone, oxazepam and methylphenidate, comparing them to positive and negative control drugs. METHODS: Sewage samples were collected in February 2014 from a wastewater treatment plant in Oslo, Norway...
November 11, 2016: Pharmacoepidemiology and Drug Safety
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